Madrigal Pharmaceuticals: The GLP-1 Threat May Be Overcooked
- Madrigal Pharmaceuticals, Inc. stock has enjoyed peaks and troughs as it has pursued its path to the approval of NASH drug Rezdiffra. The company's stock was buoyant yesterday, enjoying a 15% gain after Wolfe Research initiated positive coverage. Competition from GLP-1 agonists like Eli Lilly's tirzepatide and Novo Nordisk's semaglutide are expected to pose a threat to Rezdiffra's commercial success.
- 06/12/2024
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Better Biotech Stock: Viking Therapeutics vs. Madrigal Pharmaceuticals
- Madrigal Pharmaceuticals has a monopoly in its main market -- for the moment. Viking Therapeutics has a good candidate, but it could face powerful competitors.
- 06/10/2024
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Madrigal Pharmaceuticals Announces New Data from the Phase 3 MAESTRO-NASH Study of Rezdiffra™ (resmetirom) Presented at the EASL Congress
- CONSHOHOCKEN, Pa., June 06, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced results from new analyses of the Phase 3 MAESTRO-NASH trial of Rezdiffra being presented at the EASL Congress, which takes place from June 5-8, 2024 in Milan, Italy.
- 06/06/2024
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Is Madrigal Pharmaceuticals Stock a Buy?
- Madrigal Pharmaceuticals recently earned an impressive approval from the FDA. The biotech still has work to do to reach its peak potential with this medicine.
- 05/21/2024
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Amalgamated Bank Raises Stock Holdings in Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL)
- Amalgamated Bank boosted its holdings in Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL – Free Report) by 2.8% during the 4th quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The fund owned 2,119 shares of the biopharmaceutical company’s stock after purchasing an additional 57 shares during the period. Amalgamated Bank’s holdings in Madrigal Pharmaceuticals were worth $490,000 as of its most recent SEC filing. A number of other institutional investors have also recently bought and sold shares of the business. Tower Research Capital LLC TRC boosted its holdings in shares of Madrigal Pharmaceuticals by 21.7% in the 3rd quarter. Tower Research Capital LLC TRC now owns 2,060 shares of the biopharmaceutical company’s stock worth $301,000 after buying an additional 367 shares during the last quarter. Glenmede Trust Co. NA boosted its stake in Madrigal Pharmaceuticals by 53.2% in the third quarter. Glenmede Trust Co. NA now owns 1,567 shares of the biopharmaceutical company’s stock valued at $229,000 after acquiring an additional 544 shares during the last quarter. J.P. Morgan Private Wealth Advisors LLC purchased a new position in Madrigal Pharmaceuticals in the third quarter valued at about $314,000. Charles Schwab Investment Management Inc. grew its position in shares of Madrigal Pharmaceuticals by 11.3% during the 3rd quarter. Charles Schwab Investment Management Inc. now owns 109,501 shares of the biopharmaceutical company’s stock valued at $15,992,000 after acquiring an additional 11,083 shares during the period. Finally, Vanguard Group Inc. increased its stake in shares of Madrigal Pharmaceuticals by 7.4% during the 3rd quarter. Vanguard Group Inc. now owns 1,573,338 shares of the biopharmaceutical company’s stock worth $229,770,000 after purchasing an additional 107,816 shares during the last quarter. Institutional investors own 98.50% of the company’s stock. Madrigal Pharmaceuticals Stock Performance NASDAQ MDGL opened at $220.06 on Monday. The company’s 50 day simple moving average is $234.43 and its two-hundred day simple moving average is $221.25. The company has a debt-to-equity ratio of 0.14, a current ratio of 9.39 and a quick ratio of 9.39. Madrigal Pharmaceuticals, Inc. has a 1 year low of $119.76 and a 1 year high of $302.68. The stock has a market capitalization of $4.69 billion, a PE ratio of -9.53 and a beta of -0.33. Madrigal Pharmaceuticals (NASDAQ:MDGL – Get Free Report) last issued its quarterly earnings data on Tuesday, May 7th. The biopharmaceutical company reported ($7.38) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of ($6.06) by ($1.32). During the same period in the prior year, the firm posted ($4.23) earnings per share. Analysts predict that Madrigal Pharmaceuticals, Inc. will post -27.62 earnings per share for the current fiscal year. Wall Street Analyst Weigh In Several equities analysts have weighed in on the company. StockNews.com raised Madrigal Pharmaceuticals to a “sell” rating in a report on Friday, April 12th. B. Riley cut their price target on Madrigal Pharmaceuticals from $270.00 to $200.00 and set a “neutral” rating for the company in a research note on Friday, May 10th. TD Cowen boosted their price objective on Madrigal Pharmaceuticals from $349.00 to $390.00 and gave the company an “outperform” rating in a research note on Friday, March 15th. UBS Group increased their target price on shares of Madrigal Pharmaceuticals from $337.00 to $410.00 and gave the stock a “buy” rating in a research report on Friday, March 15th. Finally, Piper Sandler reiterated an “overweight” rating and issued a $336.00 target price on shares of Madrigal Pharmaceuticals in a research note on Thursday, March 14th. Two equities research analysts have rated the stock with a sell rating, one has assigned a hold rating and nine have given a buy rating to the stock. According to MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average target price of $345.09. Read Our Latest Report on Madrigal Pharmaceuticals Insider Buying and Selling at Madrigal Pharmaceuticals In related news, Director Richard S. Levy sold 11,000 shares of the company’s stock in a transaction that occurred on Monday, April 1st. The shares were sold at an average price of $257.48, for a total value of $2,832,280.00. Following the transaction, the director now directly owns 10,298 shares in the company, valued at $2,651,529.04. The transaction was disclosed in a document filed with the SEC, which can be accessed through the SEC website. In other news, CMO Rebecca Taub sold 2,676 shares of Madrigal Pharmaceuticals stock in a transaction on Monday, April 8th. The shares were sold at an average price of $245.99, for a total transaction of $658,269.24. Following the completion of the sale, the chief marketing officer now directly owns 458,999 shares of the company’s stock, valued at approximately $112,909,164.01. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through this hyperlink. Also, Director Richard S. Levy sold 11,000 shares of the company’s stock in a transaction on Monday, April 1st. The stock was sold at an average price of $257.48, for a total transaction of $2,832,280.00. Following the completion of the transaction, the director now owns 10,298 shares of the company’s stock, valued at $2,651,529.04. The disclosure for this sale can be found here. Insiders have sold a total of 168,985 shares of company stock valued at $36,149,878 in the last 90 days. Corporate insiders own 23.92% of the company’s stock. Madrigal Pharmaceuticals Company Profile (Free Report) Madrigal Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company, focuses on the development of therapeutics for the treatment of non-alcoholic steatohepatitis (NASH) in the United States. Its lead product candidate is resmetirom, a liver-directed thyroid hormone receptor beta agonist, which is in Phase 3 clinical trials for treating NASH.
- 05/20/2024
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Madrigal Pharmaceuticals (MDGL) Q1 2024 Earnings Call Transcript
- Madrigal Pharmaceuticals (NASDAQ:MDGL ) Q1 2024 Results Conference Call May 7, 2024 8:00 AM ET Company Participants Tina Ventura - Chief IRO Bill Sibold - CEO Mardi Dier - CFO Conference Call Participants Yasmeen Rahimi - Piper Sandler Eli Merle - UBS Liisa Bayko - Evercore Jay Olson - Oppenheimer Ritu Baral - TD Cowen Thomas Smith - Leerink Partners Akash Tewari - Jefferies Jon Wolleben - Citizens Andrea Tan - Goldman Sachs Operator Good day, and thank you for standing by. Welcome to Madrigal Pharmaceuticals First Quarter 2024 Earnings Conference Call.
- 05/07/2024
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Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates
- CONSHOHOCKEN, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today reports first-quarter 2024 financial results and provides corporate updates.
- 05/07/2024
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Madrigal: Rezdiffra Launch Gets Underway, The Only Competition Is Off-Label
- MDGL has launched Rezdiffra, the first drug approved for nonalcoholic steatohepatitis (NASH). Rezdiffra faces competition from potential off-label use of GLP-1RA drugs like semaglutide and tirzepatide, but there is potential for combination therapy too. Shortages of semaglutide and tirzepatide could help Rezdiffra's initial launch.
- 04/30/2024
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Madrigal Statement on the Passing of Dr. Stephen Harrison
- CONSHOHOCKEN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- The Madrigal team is shocked and saddened to learn of the passing of Dr. Stephen Harrison.
- 04/24/2024
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Madrigal Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
- CONSHOHOCKEN, Pa., April 16, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the company granted equity awards to 7 new employees, in each case with a grant date of April 15, 2024, as equity inducement awards under the terms of the company's 2023 Inducement Plan. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
- 04/16/2024
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7 Stocks Analysts Are Loving Right Now (And You Should Too): April 2024
- Many investors have one or more preferred fundamental or technical indicator. These help to cut through the noise surrounding a stock.
- 04/15/2024
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2 Under-the-Radar Growth Stocks to Consider
- Madrigal Pharmaceuticals recently earned a groundbreaking therapy approval. Axsome Therapeutics is getting closer to transforming its lineup of medicines.
- 04/10/2024
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Better Booming Biotech Stock: Madrigal Pharmaceuticals vs. Viking Therapeutics
- Madrigal Pharmaceuticals just commercialized its first medicine. Viking Therapeutics has a mid-stage candidate with great potential.
- 04/05/2024
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Madrigal Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
- CONSHOHOCKEN, Pa., April 03, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the company granted equity awards to 30 new employees, in each case with a grant date of April, 1 2024, as equity inducement awards under the terms of the company's 2023 Inducement Plan. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
- 04/03/2024
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1 No-Brainer Growth Stock to Buy Now
- Madrigal Pharmaceuticals scored a historical regulatory approval last month. Even so, the market has been taking a cautious approach to Madrigal's shares.
- 04/03/2024
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The 3 Best Biotech Stocks to Buy in April 2024
- Right now, biotech is one of the hottest sectors on the market, creating big opportunities for some of the best biotech stocks to buy in April. All of this is thanks to new innovation, millions of retiring baby boomers, demand for better care, pharmaceutical companies nearing patent expirations, a resurgence of mergers and acquisitions, and even new treatments that'll help you shed weight.
- 04/01/2024
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Better Buy: Viking Therapeutics vs. Madrigal Pharmaceuticals
- Viking's drug candidate has shown promise in clinical studies as a potential weight loss medicine. Madrigal just launched the first (and so far only) medicine approved by the U.S. for NASH.
- 03/29/2024
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Is This Healthcare Stock a Screaming Buy After Scoring a Huge Drug Approval?
- The Food and Drug Administration recently granted accelerated approval for Rezdiffra, a potential blockbuster for Madrigal Pharmaceuticals. At its peak, the drug could bring in more than $5 billion in revenue per year.
- 03/29/2024
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2 Top Biotech Buyout Candidates
- After a strong resurgence in the back half of 2023 and continued momentum into the first quarter of 2024, biotech stocks are back in vogue. “Hawkish” Federal Reserve Policy, a brutal bear market in 2022, and investor preference for big tech stocks have meant underperformance for biotech stocks.
- 03/28/2024
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This Under-the-Radar Stock Just Hit a Major Milestone: Time to Buy?
- Madrigal earned the first approval for a medicine in an area with a high unmet need. The commercial opportunity for this therapy, which treats a liver disease, looks exciting.
- 03/22/2024
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Is Madrigal Pharmaceuticals Stock a Better Buy Than Eli Lilly and Novo Nordisk After Its Huge FDA Win?
- Last week's FDA approval of Rezdiffra in treating NASH is a huge milestone for Madrigal. Lilly and Novo Nordisk look much more impressive than Madrigal in most ways.
- 03/19/2024
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Madrigal Pharmaceuticals Announces Pricing of Upsized $600 Million Public Offering
- CONSHOHOCKEN, Pa., March 18, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced the pricing of its underwritten public offering of 750,000 shares of its common stock at a public offering price of $260.0000 per share, and, to certain investors, pre-funded warrants to purchase 1,557,692 shares of common stock at a price of $259.9999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The size of the offering was increased by $100 million subsequent to the initial announcement of the offering. The gross proceeds to Madrigal from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $600 million. Madrigal has granted the underwriters of the offering a 30-day option to purchase up to an additional 346,153 shares of common stock from the company at the public offering price, less underwriting discounts and commissions.
- 03/18/2024
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7 Biotech Stocks Ready to Ride the Sector's Resurgence
- Why do you want to consider biotech stocks? Simply, the narrative comes down to numbers and a possible rotation.
- 03/18/2024
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Madrigal Pharmaceuticals Announces Proposed Public Offering
- CONSHOHOCKEN, Pa., March 18, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has commenced an underwritten public offering of $500 million in shares of its common stock and pre-funded warrants to purchase common stock. The purchase price of each pre-funded warrant will equal the price per share at which shares of common stock are being sold to the public in this offering, minus $0.0001, which will be the per share exercise price of each pre-funded warrant. Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares in the proposed offering are to be sold by Madrigal.
- 03/18/2024
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Madrigal: Accelerated Rezdiffra Approval Puts It In The NASH Lead
- On March 14, Madrigal Pharmaceuticals, Inc. announced that the FDA has granted accelerated approval for Rezdiffra, for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis. This accelerated approval makes Rezdiffra the first and only FDA-approved NASH treatment, which will become available in April 2024 in the US. I discuss Madrigal Pharmaceutical as an investment opportunity in this article.
- 03/18/2024
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Madrigal Pharmaceuticals Wins Approval for the First Drug Targeting the Multibillion-Dollar NASH Market. Is the Stock a Screaming Buy?
- Madrigal just won a milestone approval for Rezdiffra in treating NASH. NASH presents a massive potential market that could be worth tens of billions of dollars annually.
- 03/17/2024
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Biotech Stock Soars on FDA Drug Approval
- Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) stock is taking off today, after the U.S. Food & Drug Administration (FDA) approved the biotech company's drug for the treatment of non-alcoholic steatohepatitis (NASH), a fatty liver disease.
- 03/15/2024
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Madrigal Pharmaceuticals wins FDA approval for liver disease drug; shares soar
- Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) shares soared after the biopharmaceutical firm revealed its live disease drug Rezdiffra has won US Food and Drug Administration (FDA) approval. Shares of the company gained 18.9% at about $290 in early trade on Friday.
- 03/15/2024
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Madrigal (MDGL) Stock Up as FDA Approves First Drug for NASH
- Madrigal Pharmaceuticals' (MDGL) Rezdiffra (resmetirom) is the first and only medicine approved by the FDA for the treatment of NASH.
- 03/15/2024
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MDGL Stock Alert: The Historic Reason Madrigal Is Up 19% Today
- Madrigal Pharmaceuticals (NASDAQ: MDGL ) stock is rising higher on Friday after the company got positive news from the Food and Drug Administration (FDA)! The big news here is the FDA granting accelerated approval for Rezdiffra as a treatment for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
- 03/15/2024
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FDA approves Madrigal Pharmaceuticals drug as first treatment for common NASH liver disease
- The FDA's decision means Madrigal has succeeded in a disease area that several larger companies have failed — or are still trying to break into.
- 03/14/2024
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Madrigal Pharmaceuticals gets first FDA approval for drug targeting liver disease MASH
- Madrigal Pharmaceuticals Inc. on Thursday received the first Food and Drug Administration approval for a drug designed to treat a severe liver disease known as MASH.
- 03/14/2024
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Missed Out on Eli Lilly? 3 Healthcare Stocks With Big Catalysts on the Horizon.
- Madrigal Pharmaceuticals could be days away from winning its first FDA approval. Regeneron Pharmaceuticals expects several key regulatory decisions this year.
- 03/09/2024
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1 Wall Street Analyst Thinks Madrigal Pharmaceuticals Stock Is Going to $347. Is It a Buy Around $247?
- Madrigal Pharmaceuticals may soon get its first regulatory approval. If it happens, it will become the first and only player in a large market.
- 03/05/2024
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1 Beaten-Down Stock That Could Soar by 40%, According to Wall Street
- Madrigal Pharmaceuticals is close to a key regulatory approval that could send its stock price soaring. However, there are important issues with the company that savvy investors will consider.
- 02/23/2024
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Analysts see over 50% gains in these 2 mid-cap biotech stocks
- In recent years, emergency Covid vaccines have ushered in several groundbreaking innovations that have changed the way drugs are developed and health care is administered. Advancements in the treatment of cancer, Alzheimer's disease and obesity have highlighted steady progress in the field.
- 02/14/2024
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Madrigal Pharmaceuticals to Present at the 42nd Annual J.P. Morgan Healthcare Conference
- CONSHOHOCKEN, Pa., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced today that the Company will present at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 4:30 pm PT.
- 01/03/2024
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3 Biotech Bull Cases To Consider In 2024 - And 2 Wildcard Recommendations
- The biotech sector is finishing 2023 on a high after a difficult couple of years, buoyed by Big Pharma M&A activity. The SPDR® S&P Biotech ETF has been soaring as a result of the M&A spree. Despite a challenging year, there have been some winners in the biotech sector - I have been fortunate to share a few successful tips with Seeking Alpha readers.
- 12/29/2023
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Huge Warren Buffett Purchase Highlights Hot Insider Buying
- From executives to beneficial owners, insiders are increasingly stepping up to the buy window as we approach the end of the year.
- 12/16/2023
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These 2 Stocks Could Be About to Soar: Are They Buys?
- Madrigal aims to offer a treatment in an area where success has eluded many peers. Bluebird Bio is closing in on its third U.S. approval for a gene-editing therapy.
- 12/07/2023
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The 3 Most Undervalued Biotech Stocks to Buy: November 2023
- These companies in the biotechnology sector are doing incredible work and achieving wonderful developments. The result is not not only growth and profit for the companies, but they are also offering excellent and efficient solutions for the health of each one of us.
- 11/14/2023
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Madrigal Pharmaceuticals Bolstered By $500 Million Equity Infusion Is A 'Buy' Into 2024
- Madrigal Pharmaceuticals is transitioning from clinical trials to market-ready solutions for non-alcoholic steatohepatitis (NASH) and liver fibrosis. Their leading candidate, Resmetirom, is in Phase III clinical trials and is expected to enter the market by spring 2024, pending FDA approval. A recent injection of $500 million in equity has strengthened Madrigal's financial position and supports a positive outlook for regulatory approval by 2024.
- 11/05/2023
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2 Risky Stocks With Massive Potential
- Recursion Pharmaceuticals is looking to introduce a paradigm shift in the way biotechs develop drugs. Madrigal Pharmaceuticals developed a therapy for a disease that has eluded many of its larger peers.
- 10/17/2023
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Madrigal (MDGL) to Raise Capital Via Public Offering of $500M
- Madrigal (MDGL) is raising funds through a public offering of 1.25 million shares of its common stock to use in commercial activities in the preparation of a potential launch of resmetirom in the United States.
- 10/02/2023
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Wall Street Thinks Madrigal Pharmaceuticals Could Climb 93%. Here's Why It Could Happen Soon.
- Analysts have high hopes for Madrigal Pharmaceuticals over the coming year. Its drug resmetirom seems effective for a liver disease, non-alcoholic steatohepatitis.
- 09/27/2023
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Madrigal (MDGL) Gains on NDA for NASH Therapy Acceptance by FDA
- Madrigal (MDGL) gains as new drug application for resmeritom to treat nonalcoholic steatohepatitis gets accepted by the FDA in the United States.
- 09/14/2023
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Madrigal Pharmaceuticals shares fall after new CEO named
- Shares of Madrigal Pharmaceuticals Inc. MDGL, +2.91% fell more than 7% premarket on Monday after the company appointed Bill Sibold, a former Sanofi SNY, +1.06% executive, as its new CEO. Sibold succeeds Dr. Paul Friedman, the company's CEO since 2016, who will continue to serve on the board of directors, Madrigal said in a release.
- 09/11/2023
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The 3 Best Biotech Stocks to Buy Now: September 2023
- Biotech stocks have underperformed in the U.S. stock market by a wide margin this year. The sector's most popular index, the iShares Biotechnology ETF (NASDAQ: IBB ), is down 5% since Jan. 27.
- 09/04/2023
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3 Biotech Stocks That Wall Street Analysts Can't Get Enough Of
- This year has not been kind to biotech stocks, as the sector's most popular ETF, the iShares Biotechnology ETF (NASDAQ: IBB ), has fallen about 3% so far in 2023. Investors are probably worried about the impact of higher interest rates and potential reforms by Washington, DC on the sector.
- 08/30/2023
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The 3 Most Promising Pharma Stocks to Own Now
- It is remarkable that day after day there are pharmaceutical companies working hard, researching and developing high-tech medicines for the improvement of human health and the treatment of severe diseases. These companies not only do a good job of researching and developing cures, but they also have an incredible financial performance.
- 08/30/2023
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Madrigal's Resmetirom Nears Commercialization Despite Market Concerns
- Madrigal Pharmaceuticals is developing resmetirom, a drug for non-alcoholic steatohepatitis and fatty liver disease, with promising trial results. Madrigal has a strong cash position and manageable debt, but faces rising R&D costs and competition in the NASH therapeutics field. My recommendation remains a "Buy" for risk-tolerant investors, despite concerns about weight loss drugs reducing NASH market potential.
- 08/20/2023
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Madrigal: With Successful NASH Study, Possible Accelerated Approval Is Next
- Madrigal Pharmaceuticals, Inc. dual surrogate Primary endpoint being met in phase 3 MAESTRO-NASH study allowed for the rolling NDA submission of resmetirom for the treatment of patients with NASH. Potential for rolling NDA submission of resmetirom to be granted Priority Review Status, which would cut review time from 10 months to 6 months. The phase 3 MAESTRO-NASH-OUTCOMES study would not only grant Accelerated Approval of resmetirom to full approval, but may also allow the possibility of obtaining full approval of well-compensated NASH cirrhosis.
- 07/13/2023
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Madrigal Pharmaceuticals' stock up 5% as company starts rolling submission for FDA approval of NASH treatment
- Madrigal Pharmaceuticals Inc.'s stock MDGL, +5.00% rose 5% Friday after the company said it has started a rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of its resmetirom as a treatment for, nonalcoholic steatohepatitis, or NASH, with liver fibrosis. NASH is a more severe version of nonalcoholic fatty liver disease, or NAFLD, a range of conditions that occurs when excess fat builds up in liver cells.
- 06/30/2023
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Weight-loss drugs in development aim to replace injections with pills
- Wall Street's obsession with next-generation obesity and diabetes treatments intensified over the weekend as drugmakers presented new clinical-trial data on the drugs — including weight-loss pills in development that could become alternatives to popular injectables like Wegovy and Ozempic.
- 06/26/2023
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2 Growth Stocks That Doubled in 2023 and Could Shoot 55% to 87% Higher, According to Wall Street
- Two stocks in the healthcare sector have already doubled this year, and they could climb much higher, according to Wall Street. Viking Therapeutics is a clinical-stage biotech with an experimental treatment that could treat millions of underserved liver disease patients.
- 05/30/2023
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Madrigal: Setting The Pace In The NASH Market (Rating Upgrade)
- Madrigal Pharmaceuticals' drug, resmetirom, for non-alcoholic fatty liver diseases, received FDA's Breakthrough Therapy designation. The company is now focused on the MAESTRO-NASH-OUTCOMES trial. Madrigal's Q1 2023 financial reports show a decrease in cash holdings, and an increase in operating and R&D costs due to Phase 3 trials and workforce expansion. Competitor Intercept Pharmaceuticals faced a setback for its NASH drug, obeticholic acid, emphasizing the FDA's stringent safety and efficacy standards for NASH treatments.
- 05/30/2023
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Why Madrigal Pharmaceuticals Stock Is Marching Higher Today
- The shares are continuing a yearlong winning streak today. This latest uptick appears to be the result of two tailwinds.
- 05/24/2023
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Why These 3 Nasdaq Stocks Buckled Today
- The Federal Trade Commission is suing to block the proposed merger between Amgen and Horizon Therapeutics. This adverse regulatory action rippled out across the small- and mid-cap biotech landscape today.
- 05/16/2023
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Why Madrigal Pharmaceuticals Stock Is Slumping Today
- Madrigal Pharmaceuticals stock plummeted in early-morning trading following its 2023 Q1 earnings report. Bargain hunters were quick to buy the dip, however.
- 05/09/2023
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3 Biotechs That Might Get Bought Out in 2023
- With multiple blockbuster drugs going off patent this decade, pharma companies are expected to ratchet up their M&A activities. These three companies sport high-value assets that could attract suitors soon.
- 04/26/2023
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Why Madrigal Pharmaceuticals Stock Gained 20% This Week
- On Tuesday, Madrigal won an important regulatory designation from the FDA for its NASH candidate. The biotech got another boost from the ongoing buyout bonanza in biotech.
- 04/20/2023
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Where Is The Current Bull Market? Scan Of Stocks Gaining Over 20% Over The Past Week Almost Exclusively Yields Biotech Names
- Where is the current bull market? All indications would be that it's in biotech!
- 04/20/2023
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Madrigal (MDGL) Gains on NASH Treatment's Breakthrough Therapy Tag
- Madrigal Pharmaceuticals (MDGL) gains on receiving Breakthrough Therapy designation from the FDA for resmetirom.
- 04/19/2023
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Why Top 1% Biotech Madrigal Pharmaceuticals Just Surged Closer To A Breakout
- Madrigal snagged a breakthrough therapy designation for its liver disease treatment on Tuesday and MDGL stock surged closer to a buy point. The post Why Top 1% Biotech Madrigal Pharmaceuticals Just Surged Closer To A Breakout appeared first on Investor's Business Daily.
- 04/18/2023
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These Are the Top 10 Holdings of Avoro Capital Advisors
- Avoro Capital Advisors (formerly known as venBio Select Advisor) is a global life sciences investment firm that focuses on emerging biotechnology companies.
- 04/17/2023
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5 Best Stocks to Buy in April
- Several key themes are emerging in the stock investing landscape. These five stocks are poised to benefit from these powerful trends.
- 04/01/2023
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A Perfect Storm In Pharmacotherapy: The Opportunity To Invest In NASH
- NASH, or nonalcoholic steatohepatitis, is a liver inflammatory disease that can progress to fibrosis and cirrhosis. NASH is now the second leading cause of liver transplantation, and the US patient population is forecast to increase from 16 million in 2015 to 27 million in 2030.
- 03/29/2023
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Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle
- Intercept Pharmaceuticals said Friday its experimental liver disease treatment will face an FDA panel in May, leading ICPT stock to tumble. The post Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle appeared first on Investor's Business Daily.
- 03/10/2023
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Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle
- Intercept Pharmaceuticals said Friday its experimental liver disease treatment will face an FDA panel in May, leading ICPT stock to tumble. The post Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle appeared first on Investor's Business Daily.
- 03/10/2023
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1 Incredible Growth Stock That Could Turn $200,000 Into $1 Million by 2030
- The stock market tends to be efficient at pricing equities, but not always. Experimental drug developers in particular have often turned out to be wildly mispriced by skeptical investors.
- 03/09/2023
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This "Golden" Technical Indicator is Triggering Across the Market
- A Golden Cross is a simple, yet effective technical indicator. Andrew Rocco explains how to use it and relates it back to the current market.
- 01/26/2023
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5 Best and Worst Performing Mid-Cap Stocks in Q4 2022
- Mid-cap stocks are proving to be an attractive investment option over the past few years.
- 01/19/2023
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Madrigal: Fairly Valued At These Levels
- As everyone knows, Madrigal outperformed expectations with outstanding results stemming from Maestro NASH study. I assess Madrigal's current valuation, based on future sales potential of resmetirom in the US as a basis.
- 01/17/2023
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3 Top Healthcare Stocks to Buy for January
- These healthcare stocks have a lot going for them in the new year.
- 01/11/2023
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These Were the 5 Best and Worst Performing Mid-Cap Stocks in Dec 2022
- Mid-cap companies are fast-growing, young companies that are not as volatile as small-cap and not as stable as large-cap companies.
- 01/09/2023
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Traders who bet against stocks made a killing in 2022, as short sellers netted $300 billion
- Short holdings had a return of 30.8% in 2022 as the market slid.
- 01/05/2023
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Why These 7 Healthcare Stocks Could Soar in 2023
- With the healthcare sector poised to grow significantly in the coming years, healthcare stocks to buy present a fantastic opportunity for investors. Healthcare is something that everyone will need at some point in their lives, so today's industry of $8.3 trillion spent globally is an indication of a growing, profitable sector – one that could create many opportunities for those looking to make significant investments.
- 01/02/2023
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Madrigal Pharmaceuticals Setting The Standard
- Madrigal's lead drug candidate was already expected to be successful in its pivotal trial. FDA approval would then be earned by a positive on one of the trial's dual endpoints.
- 12/26/2022
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This Stock That Tripled in 2022 Could Rocket Even Higher in 2023
- Potential suitors with heaps of cash to spend are lining up to get a closer look at this company's results.
- 12/26/2022
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Madrigal Pharmaceuticals: Upcoming Windfall Profits
- Like an early Christmas/Hanukkah present, Madrigal shares rallied over 268% in one session due to the positive MAESTRO-NASH data. The shares continue to move in the ensuing day. Coupled with the strong Phase 3 (MAESTRO-NAFLD-1) results, Madrigal is poised to file a marketing application in H1 next year.
- 12/23/2022
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Why Madrigal Pharmaceuticals Was a Top Stock This Week
- Biotech bulls stampeded the company following its latest clinical update.
- 12/23/2022
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7 Drug Stocks That Will Soar in 2023
- Choosing the best drug stocks to buy can be dicey because drug stocks have disadvantages and advantages. On the negative side, you often have to wait many years for promising drugs to prove themselves in clinical trials.
- 12/22/2022
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Madrigal: Next Steps After 'Wow' Data In NASH
- On Monday, Madrigal Pharmaceuticals announced a best-case dataset from its phase 3 trial in NASH. This opens up a Huge market for the company.
- 12/21/2022
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Madrigal Pharmaceuticals Is Still Undervalued After Resmetirom's Phase 3 Success
- Madrigal Pharmaceuticals announced positive top-line results from their phase three trial evaluating Resmetirom as a treatment for NASH fibrosis on Monday, sending shares up by almost 300 percent since. Both the 80 milligram and 100 milligram dosages achieved statistical significance over placebo for both primary endpoints — fibrotic reduction and NASH resolution.
- 12/21/2022
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Madrigal (MDGL) Soars as Resmetirom Meets Goal in NASH Study
- Madrigal's (MDGL) phase III MAESTRO-NASH study evaluating resmetirom for treating nonalcoholic steatohepatitis and liver fibrosis meets both primary endpoints. Stock rises.
- 12/20/2022
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Madrigal's Successful Late-Stage Trial Draws Options Bulls
- Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) is surging, last seen up 250.3% to trade at $223.50, after its experimental drug Resmetirom met the main goals of a late-stage study.
- 12/19/2022
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Why Madrigal Pharmaceuticals Stock Is Crushing It Today
- The company reported stellar late-stage clinical trial results for its experimental NASH (nonalcoholic steatohepatitis) drug.
- 12/19/2022
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Madrigal Pharmaceuticals Stock Is Up 200% In One Day, Here's Why
- Madrigal Pharmaceuticals announced positive results for a major clinical trial and shares are up more than 200% because of it.
- 12/19/2022
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Madrigal Pharmaceuticals shares soar on positive trial results for its NASH and liver fibrosis drug resmetirom
- Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) shares have soared more than 250% after the biopharmaceutical company shared positive topline results from its pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The company, which is pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), said that resmetirom achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses 80mg and 100mg relative to placebo in the 52-week serial biopsy trial of more than 950 patients.
- 12/19/2022
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Why Is Madrigal Pharmaceuticals (MDGL) Stock Up 216% Today?
- Madrigal Pharmaceuticals (NASDAQ: MDGL ) stock is rocketing higher on Monday after sharing results from its novel therapeutics for nonalcoholic steatohepatitis (NASH) treatment. The company reported positive topline results, including both liver histological improvement endpoints, proposed by the U.S. Food and Drug Administration (FDA).
- 12/19/2022
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Madrigal Pharma Stock Triples After Knocking NASH Study Out Of The Park
- Madrigal scored a win in the particularly tricky NASH field on Monday after its study hit both its goals, sending MDGL stock flying. The post Madrigal Pharma Stock Triples After Knocking NASH Study Out Of The Park appeared first on Investor's Business Daily.
- 12/19/2022
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Viking Therapeutics' stock rallies after Madrigal shares positive data about its liver drug
- Shares of Viking Therapeutics Inc. VKTX, +4.42% jumped 55% in premarket trading on Monday after a company that is also developing a selective thyroid hormone receptor beta agonist as a treatment for non-alcoholic steatohepatitis (NASH) and fibrosis announced positive, late-stage data. Madrigal Pharmaceuticals Inc. MDGL, +1.43% said Monday it is aiming to get an accelerated approval in the U.S. for its drug.
- 12/19/2022
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Madrigal's stock rallies about 200% after sharing positive data about its NASH treatment candidate
- Shares of Madrigal Pharmaceuticals Inc. MDGL, +1.43% soared 209.6% in premarket trading on Monday after the company shared positive data from a pivotal Phase 3 clinical trial assessing its experimental treatment for nonalcoholic steatohepatitis (NASH) with liver fibrosis. Madrigal said it is aiming to get an accelerated approval for the drug, resmetirom.
- 12/19/2022
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Madrigal Pharmaceuticals To Announce Topline Results from the Phase 3 MAESTRO-NASH Study of Resmetirom on Monday, December 19th
- CONSHOHOCKEN, Pa., Dec. 18, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), plans to announce topline results from the Phase 3 MAESTRO-NASH study of resmetirom on Monday, December 19th, 2022.
- 12/18/2022
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Madrigal: Binary Catalyst Unlocking
- The recent Phase 3 (MAESTRO-NAFLD-1) study delivered extremely strong results. This month, Madrigal is expected to release the data for its Phase 3 (MAESTRO-NASH) trial.
- 12/13/2022
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2 Healthcare Stocks Poised to Rocket Higher in the 4th Quarter
- These two healthcare stocks could deliver market-crushing gains by year's end.
- 11/06/2022
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Madrigal Pharmaceuticals Forecast: Not So Clear
- The biopsy readout for the pivotal MAESTRO-NASH study on lead product candidate resmetirom is slated for Q4. Many expect a successful trial based on positive Phase 2 data.
- 10/29/2022
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Wall Street Thinks These 2 Nasdaq Stocks Could Go Parabolic Soon
- NASH is a common disease, but there are no approved treatments for it. These two drug companies have promising candidates in clinical trials.
- 09/15/2022
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Madrigal: Buy And Hoard Before Q4 Data Readout
- Madrigal will have a key catalytic event in Q4. This is the data from the ~900 patient subpart H population of biopsy-proven NASH patients.
- 08/04/2022
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Trial Results Set to Make or Break Small-Cap Pharma Stocks
- One analyst is putting the odds at three to one that tests of a Karuna Therapeutics Inc. ( KRTX , Financial) schizophrenia drug will meet study objectives, paving the way to Food and Drug Administration approval. If that happens, Jefferies analyst Chris Howerton believes the treatment should have “no issue” topping annual sales of $1 billion, reported BioPharma Dive.
- 07/06/2022
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Analysts Believe Madrigal's Resmetirom Shows Impressive Overall Profile In Liver Fibrosis
- Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) presented multiple resmetirom abstracts at the European Association for the Study of the Liver's International Liver Congress. The data included new details on changes in FibroScan controlled attenuation parameter and liver stiffness.
- 06/27/2022
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Madrigal Pharmaceuticals Announces Participation at Three Upcoming Investor Conferences
- CONSHOHOCKEN, Pa., June 02, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), announced today its management team will participate in three upcoming investor conferences:
- 06/02/2022
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Madrigal Pharmaceuticals Announces Participation at Two Upcoming Investor Conferences
- CONSHOHOCKEN, Pa., May 17, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), announced today its management team will participate in two upcoming investor conferences:
- 05/17/2022
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Madrigal Pharmaceuticals, Inc. (MDGL) CEO Paul Friedman on Q1 2022 Results - Earnings Call Transcript
- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL ) Q1 2022 Results Earnings Conference Call May 9, 2022 8:00 AM ET Company Participants Paul Friedman - Chairman and Chief Executive Officer Rebecca Taub - Founder, Chief Medical Officer and President of Research & Development Remy Sukhija - Chief Commercial Officer Alex Howarth - Chief Financial Officer Stephen Harrison - M.D., Medical Director, Pinnacle Clinical Research Conference Call Participants Ritu Baral - Cowen Thomas Smith - SVB Securities Yasmeen Rahimi - Piper Sandler Andrea Tan - Goldman Sachs Liisa Bayko - Evercore ISI Operator Good day, ladies and gentlemen, and welcome to the Madrigal Pharmaceuticals First Quarter 2022 Conference Call.
- 05/09/2022
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Madrigal: Clear Path Ahead
- Among many non-alcoholic steatohepatitis (NASH) drug innovators, Madrigal Pharmaceuticals is poised to deliver the first medicine to the market sometime next year. By Q4 this year, the company is anticipated to report data for the Phase 3 (MAESTRO-NASH) trial.
- 04/22/2022
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Madrigal: NASH Data In Q4 Is The Key
- MDGL announced NAFLD data in January. The 2018 NASH data has some predictive value for the phase 3 NASH trial.
- 04/19/2022
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Madrigal Pharmaceuticals to Present at the Oppenheimer Healthcare Conference
- CONSHOHOCKEN, Pa., March 09, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), announced today its management team will participate in the 32nd Annual Oppenheimer Healthcare Conference on Tuesday, March 15, 2022 at 8:00 AM ET.
- 03/09/2022
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3 Graham's Lost Formula Stocks to Consider for February
- After seeing a sell-off for most of January, two market indexes rose for the fourth day in a row on Wednesday. The S&P 500 Index was up 13.95 points, or 0.31%, while the tech-heavy Nasdaq Composite gained 0.2%.
- 02/02/2022
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Madrigal NASH Data Is Promising, Next Study Is Key For Success
- Positive results achieved from the phase 3 MAESTRO-NAFLD-1 study using resmetirom to treat patients with NASH. Nearly half of patients in 100 mg dose arm achieved 50% reduction liver fat. Key study will be MAESTRO-NASH, which will have liver biopsy data. Results for this study expected later in 2022.
- 02/01/2022
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Why Madrigal Pharmaceuticals Stock Briefly Spiked Today
- A positive data readout from a phase 3 clinical trial propelled the drugmaker's shares higher.
- 01/31/2022
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Madrigal Pharma's Kidney Disease Candidate Improves Liver, Cardiovascular Health
- Madrigal Pharmaceuticals Inc MDGL has announced topline data from Phase 3 MAESTRO-NAFLD-1 safety study of resmetirom. [ALERT] Nic Chahine shares his Bear Market Beating options trading strategy.
- 01/31/2022
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Madrigal Pharmaceuticals (MDGL) Stock: Why The Price Jumped Up Today
- The stock price of Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) increased by over 14% pre-market today. This is why it happened.
- 01/31/2022
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Madrigal Pharmaceuticals To Announce Topline Results from the Phase 3 MAESTRO-NAFLD-1 Study of Resmetirom on Monday, January 31st
- CONSHOHOCKEN, Pa., Jan. 30, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for fatty liver diseases, plans to announce topline results from the Phase 3 MAESTRO-NAFLD-1 study of resmetirom on Monday, January 31st, 2022.
- 01/30/2022
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Madrigal: Powerful Catalyst Approaching
- Back in November, Madrigal presented superb data for the open-label portion of its Phase 3 MAESTRO-NAFLD-1 trial. Next month, the company is poised to release additional data for the blinded segment of the aforesaid study.
- 01/09/2022
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3 Biotech Stocks With Major Catalysts in January
- Binary events on the way could send these drugmaker stocks through the roof, or push them down in the dirt.
- 01/04/2022
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Madrigal Pharmaceuticals Stock (MDGL): Why The Price Increased
- The stock price of Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) increased by 2.95% in the previous trading session. This is why it happened.
- 12/31/2021
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Madrigal Pharmaceuticals Announces Participation at Two Upcoming Virtual Investor Conferences
- CONSHOHOCKEN, Pa., Nov. 23, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today its management team will participate in two upcoming virtual investor conferences:
- 11/23/2021
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Madrigal: Major Catalyst Coming Up
- Madrigal announced data at AASLD that was published earlier. They have their most important catalyst coming up.
- 11/14/2021
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Madrigal Pharmaceuticals Announces Support of Fatty Liver Foundation's Screening Fund to Improve Diagnosis and Staging of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)
- In recognition of Liver Awareness Month, Madrigal and Fatty Liver Foundation Ring Nasdaq Closing Bell to Increase Awareness of NAFLD/NASH In recognition of Liver Awareness Month, Madrigal and Fatty Liver Foundation Ring Nasdaq Closing Bell to Increase Awareness of NAFLD/NASH
- 10/04/2021
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Madrigal Pharmaceuticals Reports 2021 Second Quarter Financial Results and Provides Corporate Update
- CONSHOHOCKEN, Pa., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reports today its second quarter 2021 financial results and provides a summary of corporate accomplishments.
- 08/05/2021
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Robert Waltermire Joins Madrigal Pharmaceuticals as Chief Pharmaceutical Development Officer
- CONSHOHOCKEN, Pa., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need, announced today that Dr. Robert
- 08/02/2021
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Here's Why Madrigal (MDGL) is Poised for a Turnaround After Losing 14.9% in 4 Weeks
- Madrigal (MDGL) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.
- 07/27/2021
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Madrigal Pharmaceuticals Offers Patients Resmetirom in a Planned Open Label Active Treatment Extension of the Phase 3 MAESTRO-NAFLD-1 Clinical Study
- CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219). MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH. The study is due to complete later this year with measures of safety and efficacy including reduction in imaging and biomarker measures of NASH, as well as the lowering of LDL-cholesterol and other atherogenic lipids.
- 07/13/2021
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Madrigal Pharmaceuticals Completes Enrollment of the 52 Week Liver Biopsy Patient Population in the Phase 3 MAESTRO-NASH Study of Resmetirom
- CONSHOHOCKEN, Pa., June 30, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today achievement of the planned target enrollment in the Phase 3 clinical trial, MAESTRO-NASH. Serial liver biopsy and safety data from patients enrolled in MAESTRO-NASH coupled with safety data from MAESTRO-NAFLD-1, an additional large Phase 3 study, are expected to support the planned Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to the US Food and Drug Administration (FDA). Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.
- 06/30/2021
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Madrigal Pharmaceuticals Announces Presentation of Positive Clinical Data of Resmetirom from Open-Label Portion of Ongoing Phase 3 Clinical Trial MAESTRO-NAFLD-1 at The International Liver Congress™ 2021
- CONSHOHOCKEN, Pa., June 25, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), today announced the presentation of positive clinical data from the open-label portion of its ongoing Phase 3 MAESTRO-NAFLD-1 study of resmetirom at the European Association for the Study of the Liver Annual Meeting, The International Liver Congress™ 2021, being held virtually, June 23-26, 2021. The data continue to position resmetirom as a promising treatment option for nonalcoholic steatohepatitis (NASH) patients.
- 06/25/2021
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Madrigal Pharmaceuticals Announces Participation at Two Upcoming Virtual Investor Conferences
- WEST CONSHOHOCKEN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical- stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today its management team will participate in two upcoming virtual investor conferences:
- 06/08/2021
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20 Short Ideas With Super-Weak Momentum
- Often, weak stocks going into a market correction or bear move will decline faster than the main indexes. I have listed 20 stocks/ETFs out of a 4000+ sort universe experiencing a rush of selling since March.
- 05/31/2021
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Madrigal Pharmaceuticals to Participate in UBS Global Healthcare Virtual Conference
- WEST CONSHOHOCKEN, Pa., May 21, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today that members of its executive team, including Paul Friedman, M.D., Chief Executive Officer, Becky Taub, M.D., Chief Medical Officer and President of Research and Development, Remy Sukhija, Senior Vice President and Chief Commercial Officer and Alex Howarth, Chief Financial Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 4:00 pm ET.
- 05/21/2021
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Alex Howarth Joins Madrigal Pharmaceuticals as Chief Financial Officer
- WEST CONSHOHOCKEN, Pa., May 18, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need, announced today that Alex Howarth has joined Madrigal as Chief Financial Officer.
- 05/18/2021
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Madrigal Pharmaceuticals Reports 2021 First Quarter Financial Results and Highlights
- WEST CONSHOHOCKEN, Pa., May 06, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first quarter 2021 financial results and highlights.
- 05/06/2021
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Madrigal Pharmaceuticals: Leading The NASH Innovation
- The Phase 2 data has been excellent while the company is most likely to present strong data for its Phase 3 MAESTRO-NAFLD-1 trial in late 2021.
- 05/05/2021
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The Promises Behind Terns' Multi-Pronged Pipeline
- This pharma may be a newcomer to the stock market, but it has several innovative drugs in development for a common condition with no current treatments approved.
- 03/26/2021
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Madrigal Pharmaceuticals Reports 2020 Fourth Quarter and Full Year Financial Results and Highlights
- WEST CONSHOHOCKEN, Pa., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its fourth quarter and full year 2020 financial results and highlights.
- 02/25/2021
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Reddit playing a major role in biotech trading action, says Jefferies top health care analyst
- Jared Holz, Jefferies managing director and healthcare sector specialist, on which biotech stocks could be the next targets. With Melissa Lee and the Fast Money traders, Guy Adami, Tim Seymour, Karen Finerman and Brian Kelly.
- 02/04/2021
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Gamestopping Biopharma: These Three Stocks May See A Short Squeeze Soon
- The GameStop effect will soon come to biopharma, an usually heavily-shorted sector. Here's a list of three of biopharma's more heavily-shorted stocks.
- 01/31/2021
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Madrigal Pharma: A Look At The Early MAESTRO Trial Data
- In November, Madrigal released open label data from the MAESTRO-NAFLD study. This data was positive, and could be used to make predictions about the entire study.
- 11/27/2020
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Madrigal Pharmaceuticals Highlights Presentations at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting November 13, 2020, Including NASH Expert Insights on the Ongoing Open Label Arm of Resmetirom 52-Week Phase 3 MAESTRO-NAFLD-1 Trial
- CONSHOHOCKEN, Pa., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), announced that Dr. Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies, will make an oral presentation today at 4:30 PM ET at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting, November 2020 accessible via the Product Theaters and Satellite Symposium page. Dr. Harrison's presentation, based on data from studies with MGL-3196 (resmetirom), will also highlight key insights from three posters, which are available to registered attendees on The Liver Meeting Digital Experience™ website throughout the four-day meeting. Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist and is currently in Phase 3 development for the treatment of NASH patients both with biopsy-confirmed fibrosis stage 2-3 (ClinicalTrials.gov NCT03900429) and in presumed NASH subjects diagnosed non-invasively (ClinicalTrials.gov/NCT04197479).
- 11/13/2020
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Madrigal Pharmaceuticals Announces Completion of Enrollment in Phase 3 MAESTRO NAFLD-1 Trial and Reports 2020 Third Quarter Financial Results and Highlights
- CONSHOHOCKEN, Pa., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that it completed enrollment in its MAESTRO NAFLD-1 clinical trial of resmetirom in patients with presumed NASH who are diagnosed using non-invasive assessments. The Company also announced its third quarter 2020 financial results and highlights.
- 11/05/2020
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Terns Pharmaceuticals to Present Clinical Data on Improved TERN-101 Tablet Formulation at the Paris NASH Digital Experience
- Terns Pharmaceuticals to Present Clinical Data on Improved TERN-101 Tablet Formulation at the Paris NASH Digital Experience
- 10/22/2020
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Poxel dresse un bilan de ses activités et publie sa position de trésorerie et son chiffre d’affaires du troisième trimestre et des neuf premiers mois de 2020
- Regulatory News: POXEL (Euronext – POXEL - FR0012432516, éligible PEA-PME), société biopharmaceutique spécialisée dans le développement de traitements
- 10/20/2020
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89bio: Near And Long-Term Investment Cases Excite As Company Targets NASH Opportunity (NASDAQ:ETNB)
- 89bio has emerged as a competitive player in the race to have a treatment approved for nonalcoholic steatohepatitis (“NASH”) - a potential multi-billion dollar market.
- 10/14/2020
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Terns Pharmaceuticals to Present Positive Data on Single-Agent and Combination NASH Programs at The Liver Meeting® Digital Experience 2020
- Terns Pharmaceuticals to Present Positive Data on Single-Agent and Combination NASH Programs at The Liver Meeting® Digital Experience 2020
- 10/14/2020
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Inventiva sa : Inventiva décroche une Breakthrough Therapy dans la NASH, une première depuis 2015
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The Daily Biotech Pulse: J&J Pauses Coronavirus Vaccine Studies, Voyager's Huntington's Disease Study Placed On Hold, Altimmune Vaccine Data
- Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Oct. 12)
10X Genomics Inc (NASDAQ:...
- 10/13/2020
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Inventiva S A : reçoit le statut de « Breakthrough Therapy » de la part de la FDA pour lanifibranor, son principal candidat médicament dans la NASH | Zone bourse
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Global Nash Drugs Market 2020 Growth by Forthcoming Developments, Future Prospects, Opportunity, Industry Scope, Business Strategy and COVID-19 Market Scenario | Report by Industry Research biz
- Oct 07, 2020 (The Expresswire) --
Global “Nash Drugs Market” research report offers qualitative and quantitative insights in relation to industry growth...
- 10/07/2020
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The Daily Biotech Pulse: Mesoblast Slumps On FDA Rejection, AstraZeneca's Breakthrough Therapy Designation, 3 IPOs
- Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Oct. 1)
10X Genomics Inc (NASDAQ:...
- 10/02/2020
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GENFIT SA (GNFT) CEO Pascal Prigent on Q2 2020 Results - Earnings Call Transcript
- GENFIT SA (NASDAQ:GNFT) Q2 2020 Results Conference Call September 30, 2020 04:30 PM ET Company Participants Stefanie Magner - Deputy Director, Legal Affairs Pascal Prigent - CEO Dean Hum - Chief Scientific Officer and COO Conference Call Participants Thomas Smith - SVB Leerink Derek Archila - Stifel Thomas Yip - H.C.
- 10/01/2020
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Poxel Announces Positive Results From Phase 2a NASH Trial With PXL770, an Oral First-in-Class Direct AMPK Activator
- POXEL SA (Euronext: POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, in
- 10/01/2020
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Can-Fite Selected to Deliver Late-Breaking Oral Presentation on Namodenoson’s Treatment of NASH at American Association for the Study of Liver Diseases Conference
- Can-Fite Selected to Deliver Late-Breaking Presentation on Namodenoson’s Treatment of NASH at American Association for the Study of Liver Diseases
- 09/30/2020
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COVID-19 Forces One of the Biggest Surges in Technology Investment in History, Finds World’s Largest Technology Leadership Survey
- COVID-19 forces one of the biggest surges in tech investment in history, finds Harvey Nash/KPMG CIO Survey.
- 09/22/2020
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U.S. IPO Weekly Recap: Snowflake's IPO Breaks Records In A Diverse 15-IPO Week
- In the busiest week yet for the 2020 IPO market, 15 IPOs raised $8.7 billion. Snowflake took the spotlight, completing the largest software IPO ever and bagging the biggest billion-dollar pop in two decades.
- 09/19/2020
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Résultats financiers du 1er semestre 2020 et point sur l'activité
- Trésorerie et équivalents de trésorerie à 52,3 M€ au 30 juin 2020
Succès de l'introduction en bourse sur le Nasdaq Global Market, avec une levée de 107,7 M$ (94,9 M€) prolongeant la visibilité financière de la société jusqu'au T4 2022
Publication des résultats positifs de l'étude clinique de Phase IIb de NATIVE évaluant lanifibranor dans la NASH et décision d'entrer en étude pivot de Phase III
Publication de nouvelles données de l'étude clinique de Phase IIb NATIVE dans la NASH montrant une diminution significative des biomarqueurs de la fibrose, de l'apoptose et de l'inflammation après 24 semaines de traitement avec lanifibranor
Nomination du Dr Arun J. Sanyal au Conseil Scientifique (Scientific Advisory Board - SAB) d'Inventiva, renforçant l'expertise du Conseil dans le domaine de la NASH
Approbation par la Food and Drug Administration (FDA) américaine de la demande IND (Investigational New Drug) pour odiparcil dans la MPS VI permettant le lancement d'études cliniques aux États-Unis
Daix (France), le 16 septembre 2020 - Inventiva (Euronext Paris et Nasdaq : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de la stéatohépatite non alcoolique (NASH), des mucopolysaccharidoses (MPS) et d'autres maladies avec un besoin médical non satisfait significatif, publie aujourd'hui ses résultats financiers du premier semestre, clos au 30 juin 2020, et fait le point sur son activité
- 09/16/2020
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Résultats financiers du 1er semestre 2020 et point sur l’activité
- Trésorerie et équivalents de trésorerie à 52,3 M€ au 30 juin 2020Succès de l'introduction en bourse sur le Nasdaq Global Market, avec une levée de 107,7...
- 09/16/2020
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Poxel publie ses résultats financiers du premier semestre 2020 et dresse un bilan de ses activités
- Regulatory News: POXEL SA (Paris:POXEL) (Euronext : POXEL — FR0012432516), société biopharmaceutique spécialisée dans le développement de traitements
- 09/15/2020
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Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-297, its Highly Potent and Targeted Follow-On Farnesoid X Receptor Agonist for the Treatment of Non-Alcoholic Steatohepatitis
- Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-297, its Highly Potent and Targeted Follow-On Farnesoid X Receptor Agonist for NASH
- 09/14/2020
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Enanta Pharmaceuticals Presents New Data from its Hepatitis B and Non-Alcoholic Steatohepatitis Programs at the Digital International Liver Congress™ 2020
- Enanta Pharmaceuticals Presents New Data from its Hepatitis B and Non-Alcoholic Steatohepatitis Programs at the Digital International Liver Congress
- 08/28/2020
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Can-Fite Reports Second Quarter 2020 Financial Results & Provides Clinical Update
- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that addre
- 08/27/2020
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Madrigal Pharmaceuticals to Present Secondary Analyses of Data from Phase 2 NASH Study of Resmetirom and Symposium at the Digital International Liver Congress™ 2020
- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that on Friday, August 28, 2020 at the Digital International Liver Congress™ 2020, European
- 08/26/2020
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Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020
- Gilead Sciences, Inc. (Nasdaq: GILD) announced the presentation of more than 40 abstracts reflecting the breadth of research from the company’s progra
- 08/25/2020
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Global Non-Alcoholic Steatohepatitis (NASH) Pipeline Review, H2 2020 - ResearchAndMarkets.com
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Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) Major Shareholder Sells $786,094.92 in Stock
- Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) major shareholder Bay City Capital Llc sold 7,303 shares of the company’s stock in a transaction that occurred on Wednesday, August 19th. The shares were sold at an average price of $107.64, for a total value of $786,094.92. The transaction was disclosed in a filing with the SEC, which can be […]
- 08/22/2020
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Intercept to Present New NASH and PBC Data at the Digital International Liver Congress™ 2020
- New analyses of the interim analysis data from the Phase 3 REGENERATE study describe the benefit of obeticholic acid (OCA) on noninvasive measures of liver
- 08/21/2020
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The Daily Biotech Pulse: Gilead's Filgotinib Stumbles With FDA, J&J Laps Up Momenta In $6.5B Deal, 2 IPOs
- Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Aug. 18)
Avenue Therapeutics Inc (NASDAQ: ATXI)
Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)
DarioHealth Corp (NASDAQ:...
- 08/19/2020
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Founders’ story: Pleiogenix
- Pleiogenix is a biopharma startup developing treatments for liver diseases as well as Covid-19 and non-alcoholic steatohepatitis (NASH). It recently emerged as the winner of the INVEST Pitch Perfect contest for the biopharma track.
- 08/18/2020
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Viking Therapeutics: Another Year In Review
- Recently announced Q2'20 financial results and provided key updates on development timelines. Filed IND for VK0214 in X-ALD.
- 08/13/2020
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CymaBay Therapeutics Inc. (CBAY) Q2 2020 Earnings Call Transcript | The Motley Fool
- CBAY earnings call for the period ending June 30, 2020.
- 08/11/2020
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How Adam Smith Might Have Valued Amazon, Netflix, Tesla, And Tiny Biotechs (NASDAQ:AMZN)
- Adam Smith's invisible hand implies that the value a business provides to its customers is conjoined with the value of a business to its self-interested owners.
- 08/10/2020
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Inventiva S A : Descriptif du programme limité de rachat d'actions & reprise du contrat de liquidité | Zone bourse
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Inventiva S A : DESCRIPTIF DU PROGRAMME LIMITE DE RACHAT D'ACTIONS & REPRISE DU CONTRAT DE LIQUIDITE | Zone bourse
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Terns Pharmaceuticals Appoints Senthil Sundaram as Chief Executive Officer, Mark Vignola, Ph.D., as Chief Financial Officer, and Erin Quirk, M.D., as President
- Terns Pharmaceuticals Appoints Senthil Sundaram as CEO, Mark Vignola, Ph.D., as CFO, and Erin Quirk, M.D., as President.
- 08/10/2020
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Galmed Pharmaceuticals Ltd. (GLMD) CEO Allen Baharaff on Q2 2020 Results - Earnings Call Transcript
- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q2 2020 Results Conference Call August 06, 2020 08:30 AM ET Company Participants Allen Baharaff - President and CEO Dr.
- 08/09/2020
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Alnylam Managing Through Covid-19 Challenges And Executing Well (NASDAQ:ALNY)
- COVID-19 drove a double-digit sequential decline in U.S. Onpattro revenue, but both Onpattro and Givlaari revenue exceeded expectations, with management lifting the lower end of its Onpattro revenue forecast.
- 08/07/2020
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Novo Nordisk A/S (NVO) CEO Lars Fruergaard Jorgensen on Q2 2020 Results - Earnings Call Transcript
- Novo Nordisk A/S (NYSE:NVO) Q2 2020 Earnings Conference Call August 6, 2020 07:00 ET Company Participants Lars Fruergaard Jorgensen - Chief Executive Officer Mads Krogsgaard Thomsen - EVP & Chief Science Officer Karsten Munk Knudsen - EVP & Chief Financial Officer Camilla Sylvest - EVP & Head, Commercial Strategy & Corporate Affairs Conference Call Participants Peter Verdult - Citigroup Wimal Kapadia - Sanford C.
- 08/07/2020
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Amarin Earnings, And Other News: The Good, Bad And Ugly Of Biopharma (NASDAQ:AMRN)
- Amarin reports better than expected financial numbers for second quarter. CytoDyn reports positive DSMC opinion for COVID-19 trial.
- 08/06/2020
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Madrigal Pharmaceuticals Reports 2020 Second Quarter Financial Results and Highlights
- CONSHOHOCKEN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its second quarter 2020 financial results and highlights: “The Madrigal team and our CRO’s are focused on completing enrollment of both of our Phase 3 MAESTRO clinical trials as rapidly as possible,” said Becky Taub, M.D., CMO and President, Research & Development of Madrigal. “MAESTRO-NAFLD-1, a 52-week study in which NASH is diagnosed non-invasively, has enrolled well throughout 2020, and we anticipate completion of enrollment as scheduled by the end of 2020. We expect to report data from an open label 100 mg arm of MAESTRO-NAFLD-1 by the end of this year, including selected data from noninvasive tests: liver fat (MRI-PDFF) at week 16, fibrosis biomarkers, liver enzymes, and atherogenic lipids and lipoproteins, key endpoints from the trial.”“The global coronavirus pandemic has presented significant challenges to the entire pharmaceutical industry in the conduct of clinical studies in 2020,” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. “Consistent with guidance from regulatory agencies, we put in place more flexible processes at clinical sites early on to allow patients to continue participating in our Phase 3 NASH studies. Screening for MAESTRO-NASH was negatively impacted for some months by temporary closures of liver biopsy facilities that occurred globally. Screening and new enrollment are again underway. We have been and are continuing to apply multiple mitigation strategies to increase patient recruitment rates, including opening new trial sites and enrolling patients with existing biopsies from NASH trials which were discontinued and/or in which the drug was inactive in NASH. We are hopeful that positive developments will allow us to make up the deficit that has occurred. However, the pandemic remains unpredictable, and completion of targeted enrollment for the serial liver biopsy portion of MAESTRO-NASH may be delayed past the end of 2020 by a few months.” Dr. Friedman continued, “On a different topic, we are also pleased to report that, effective today, NASDAQ has upgraded the listing of Madrigal’s common stock from the NASDAQ Capital Market (Tier 3) to the NASDAQ Global Select Market (Tier 1). The Global Select Market is for public companies that meet the highest listing standards in the world.”Financial Results for the Three and Six Months Ended June 30, 2020As of June 30, 2020, Madrigal had cash, cash equivalents and marketable securities of $384.4 million, compared to $439.0 million at December 31, 2019. The decrease in cash and marketable securities resulted primarily from cash used in operations of $54.8 million.Operating expenses were $50.3 million and $88.3 million for the three and six month periods ended June 30, 2020, compared to $22.7 million and $40.8 million in the comparable prior year periods.Research and development expenses for the three and six month periods ended June 30, 2020 were $44.7 million and $78.1 million, compared to $15.6 million and $28.0 million in the comparable prior year periods. The increases are primarily attributable to additional activities related to the Phase 3 clinical trials initiated in 2019, and an increase in head count.General and administrative expenses for the three and six month periods ended June 30, 2020 were $5.6 million and $10.2 million, compared to $7.1 million and $12.9 million in the comparable prior year periods. The decreases in general and administrative expenses for the latest three and six month periods were due primarily to a decrease in non-cash stock compensation from stock option awards, which was partially offset by increases in other general and administrative expenses. Interest income for the three and six month periods ended June 30, 2020 was $1.2 million and $3.1 million, compared to $3.0 million and $6.0 million in the comparable prior year periods. The decreases in interest income for the latest three and six month periods were due primarily to lower average principal balances in our investment accounts in 2020, and decreased interest rates.About Resmetirom (MGL-3196) Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone.To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone. The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR- β receptor functional selectivity based on both in vitro and in vivo assays 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.About the Phase 3 Registration Program for the Treatment of NASH (Non-alcoholic steatohepatitis) Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts NASH resolution and liver fibrosis reduction and, specifically, that the resmetirom doses being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve the level of fat reduction predictive of NASH resolution and fibrosis reduction [Madrigal COVID and ABSTRACT Press Release_20200414].The Phase 3 MAESTRO-NASH trial is expected to enroll 900 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. After 52 weeks of treatment a second biopsy is performed. The primary surrogate endpoint on biopsy will be NASH resolution, with at least a 2-point reduction in NAS (NASH Activity Score), and with no worsening of fibrosis. Two key secondary endpoints are liver fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol [ClinicalTrials.gov/NCT03900429].A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in December 2019 in 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in up to 100 patients. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a non-biopsy study and represents a “real-life” NASH study. NASH or presumed NASH is documented using historical liver biopsy or non-invasive techniques including fibroscan and MRI-PDFF. Using non-invasive measures, MAESTRO-NAFLD-1 is designed to provide incremental safety information to support the NASH indication as well as provide additional data regarding clinically relevant key secondary efficacy endpoints to better characterize the potential clinical benefits of resmetirom on cardiovascular and liver related endpoints. These key secondary endpoints include LDL-cholesterol, apolipoprotein B and triglyceride (TG) lowering; reduction of liver fat as determined by magnetic resonance imaging, proton density fat fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis biomarker. [ClinicalTrials.gov/NCT04197479] Additional secondary and exploratory endpoints will be assessed including reduction in liver enzymes, fibroscan scores and other fibrosis and inflammatory biomarkers. These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of NASH. The original 900 patients in the MAESTRO-NASH study will continue on therapy after the initial 52-week treatment period; up to another 1,100 patients are to be added using the same randomization plan and the study is expected to continue for up to 54 months to accrue and measure clinical events, most relevantly progression to cirrhosis. About Resmetirom’s Potential to Confer Cardiovascular Risk Reduction in NASH patients Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other NASH therapeutics. The magnitude of reduction of these lipids support a potential indication for treatment of hyperlipidemia in NASH patients and predicts a potential for benefit on cardiovascular (CV) events in NASH patients who die most frequently of CV, not liver disease.
- 08/06/2020
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Fractyl Raises $55 Million in Series E Financing to Advance Revita DMR for Type 2 Diabetes
- Fractyl's first close of $55 million will be used to support the Revita T2Di pivotal US clinical trial of Revita DMR to treat type 2 diabetes.
- 08/06/2020
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Merck & Co to repurpose failed obesity drug for NASH -
- Merck & Co is to pay $10 million to Hanmi to repurpose a drug discarded by Johnson & Johnson in obesity into a therapy for the fatty liver disease also known as NASH.
- 08/05/2020
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GENFIT : la technologie NIS4 objet d'une publication dans The Lancet Gastroenterology
- (AOF) - Genfit annonce que les données décrivant la dérivation et la validation de NIS4 ont été acceptées pour publication dans The Lancet Gastroenterology & Hepatology. NIS4 est la technologie diagnostique non-invasive innovante basée sur une prise de sang développée par la société biopharmaceutique afin d'identifier les patients atteints de stéatohépatite non-alcoolique (NASH) et fibrose significative (F>2), défini comme NASH à risque dans l'article publié
- 08/05/2020
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GENFIT : la technologie NIS4 objet d’une publication dans The Lancet Gastroenterology
- (AOF) - Genfit annonce que les données décrivant la dérivation et la validation de NIS4 ont été acceptées pour publication dans The Lancet Gastroenterology & Hepatology. NIS4 est la technologie diagnostique
- 08/05/2020
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GENFIT : la technologie NIS4 objet d’une publication dans The Lancet Gastroenterology | Zone bourse
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GENFIT : La technologie NIS4™ objet d'une publication dans The Lancet Gastroenterology and Hepatology pour l'identification de patients atteints de NASH à risque | Zone bourse
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Enanta Pharmaceuticals Inc (ENTA) Q3 2020 Earnings Call Transcript | The Motley Fool
- ENTA earnings call for the period ending June 30, 2020.
- 08/05/2020
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The Daily Biotech Pulse: Novavax Vaccine Data, Aerpio Gets $5.1M Funding For COVID Trial, Rigel Gains Big On Earnings
- Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Aug. 4)
ABIOMED, Inc. (NASDAQ: ABMD) (FDA approved the emergency use of Abiomed's Impella heart pump in combination...
- 08/05/2020
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Merck, Hanmi sign $870M deal for NASH drug
- Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
- 08/04/2020
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Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) Shares Purchased by Cambridge Investment Research Advisors Inc.
- Cambridge Investment Research Advisors Inc. boosted its holdings in Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) by 4.7% during the 2nd quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The firm owned 15,560 shares of the biopharmaceutical company’s stock after acquiring an additional 700 shares during the quarter. Cambridge […]
- 08/04/2020
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Durect Corp (DRRX) Q2 2020 Earnings Call Transcript | The Motley Fool
- DRRX earnings call for the period ending June 30, 2020.
- 08/04/2020
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Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy for Nonalcoholic Steatohepatitis (NASH)
- Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy for NASH
- 08/04/2020
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INVEST Pitch Perfect winner spotlight: Pleiogenix eyes road ahead for liver disease drug
- The company is hoping to close its seed funding round in the next six months and aims to be in a position to seek regulatory approval for its lead asset, PLX888, in acute alcoholic hepatitis in 2023.
- 08/03/2020
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Enanta Pharmaceuticals to Present at the BTIG Virtual Biotechnology Conference 2020
- Enanta Pharmaceuticals to Present at the BTIG Virtual Biotechnology Conference 2020
- 08/03/2020
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3 “Perfect 10” Stocks To Consider During Uncertain Times
- Stocks Analysis by Investing Insights covering: Arrowhead Pharmaceuticals Inc, LKQ Corporation, Dropbox Inc. Read Investing Insights 's latest article on Investing.com
- 07/30/2020
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Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
- Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
- 07/27/2020
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French biotech Genfit shifts gears after Phase III NASH failure
- The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
- 07/23/2020
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Xconomy: FDA Lifts CymaBay Drug Hold, Tests to Resume in Rare Liver Disease PBC
- The FDA has lifted a hold on clinical trials for an experimental CymaBay Therapeutics drug in three liver diseases, clearing the way for tests to resume
- 07/23/2020
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Genfit abandons late-stage trial of NASH drug elafibranor -
- France’s Genfit has said its elafibranor drug as a treatment for non-alcoholic steatohepatitis (NASH) was unable to improve
- 07/23/2020
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Genfit : renonce à traiter la NASH et cherche d'autres applications à l'Elafibranor | Zone bourse
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Terns Pharmaceuticals Announces Initiation of Patient Dosing in the LIFT Study, a Phase 2a Clinical Trial of TERN-101 in Development for NASH
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Terns Pharmaceuticals Announces Initiation of Patient Dosing in the LIFT Study, a Phase 2a Clinical Trial of TERN-101 in Development for NASH
- Terns Pharmaceuticals, Inc., a global biopharmaceutical company focused on discovering and developing innovative therapies to treat non-alcoholic stea
- 07/22/2020
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Poxel : dresse son bilan d'activité et publie sa position de trésorerie et son chiffre d'affaires pour le deuxième trimestre et le premier semestre 2020 | Zone bourse
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Ascletis Pharma : Bridging Study in China Completed for NASH Drug Candidate ASC40 | MarketScreener
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Can-Fite Completes Development of an Assay to Identify Clinically Active Cannabis Derived Compounds
- Can-Fite Completes Development of an Assay to Identify Clinically Active Cannabis Derived Compounds
- 07/20/2020
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Brokerages Expect Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) to Announce -$2.42 Earnings Per Share
- Wall Street analysts expect Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) to announce earnings of ($2.42) per share for the current quarter, Zacks reports. Zero analysts have issued estimates for Madrigal Pharmaceuticals’ earnings, with estimates ranging from ($2.50) to ($2.24). Madrigal Pharmaceuticals posted earnings per share of ($1.28) during the same quarter last year, which would indicate a […]
- 07/19/2020
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Theratechnologies Inc. (THTX) Q2 2020 Earnings Call Transcript | The Motley Fool
- THTX earnings call for the period ending May 31, 2020.
- 07/16/2020
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Inventiva S A : annonce la réalisation de son introduction en bourse sur le Nasdaq Global Market pour un montant de 107,7 millions de dollars U.S. | Zone bourse
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Glympse Bio raises more than $46M in Series B round for biosensor technology
- The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
- 07/15/2020
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Inventiva S A : annonce la décision de l'investigateur de réduire le nombre de patients dans l'étude de Phase II en cours évaluant lanifibranor chez des patients atteints de diabète de type 2 (T2DM) et de stéatose hépatique non alcoolique (NAFLD) | Zone bourse
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Can-Fite Completes Phase II COVID-19 Protocol Based on FDA Guidance, Plans to File IND Shortly
- Can-Fite Completes Phase II COVID-19 Protocol Based on FDA Guidance, Plans to File IND Shortly
- 07/15/2020
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FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
- Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that
- 07/14/2020
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Inventiva S A : annonce la mise à disposition d'un prospectus dans le cadre de son offre au public d'actions ordinaires sous la formes d'ADS à l'occasion de son introduction en bourse sur le Nasdaq Global Market | Zone bourse
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Inventiva S A : annonce la reprise des négociations de ses actions ordinaires sur Euronext Paris | Zone bourse
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Inventiva S A : annonce la suspension temporaire du cours de ses actions ordinaires sur Euronext Paris | Zone bourse
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Inventiva S A : annonce le dépôt d'un « amendement » au document d'enregistrement (Form F-1) incluant une fourchette de prix indicative | Zone bourse
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CytoDyn: Bears Bring Out Their Champion To Take On The Army Of Bulls (OTCMKTS:CYDY)
- CytoDyn’s stock is under selling pressure following a short-centric report from the notorious Citron Research.
- 07/08/2020
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Biogen Stock Is Jumping. The Biotech Submitted Its Troubled Alzheimer’s Drug for FDA Approval.
- Biogen has finished submitting its application for approval for aducanumab to the Food and Drug Administration. That submission was originally expected to be completed in early 2020.
- 07/08/2020
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Better Coronavirus Stock: Altimmune vs. Vaxart | The Motley Fool
- Both of these small-cap vaccine stocks are up big in 2020.
- 07/08/2020
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89bio Announces Pricing of Upsized Public Offering of Common Stock
- SAN FRANCISCO, July 07, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and...
- 07/08/2020
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City gas distribution companies under pressure; MGL, IGL decline up to 5%
- PNGRB has said the regulation for allowing competition in CGD areas will be notified in the next one to one and a half months.
- 07/07/2020
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Poxel : nombre d’actions et de droits de vote composant le capital social
- Regulatory News: Poxel (Paris:POXEL) : Conformément aux dispositions de l’article L.233-8 II du Code de Commerce et de l’article 223-16 du Règlement G
- 07/07/2020
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IPO Update: Inventiva SA Looks For $102 Million U.S. IPO (Pending:IVA)
- Inventiva SA has filed proposed terms for a U.S. IPO of $102 million.
- 07/06/2020
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Inventiva S A : annonce le début du roadshow dans le cadre de son projet d'Offre Globale et de son projet de cotation au Nasdaq | Zone bourse
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Inventiva S A : Information financière du 1er semestre 2020 | Zone bourse
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Information financière du 1er semestre 2020
- Trésorerie et équivalents de trésorerie à 52,2 M€ au 30 juin 2020
Daix (France), le 6 juillet 2020 - Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de la stéatohépatite non alcoolique (NASH), des mucopolysaccharidoses (MPS) et d'autres maladies avec un besoin médical non satisfait significatif, publie aujourd'hui sa position de trésorerie au 30 juin 2020.
Au 30 juin 2020, la trésorerie et les équivalents de trésorerie d'Inventiva s'élevaient à 52,2 millions d'euros contre 46,9 millions d'euros au 31 mars 2020 et 35,8 millions d'euros au 31 décembre 2019
- 07/06/2020
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Inventiva annonce la décision de l’investigateur de réduire le nombre de patients dans l'étude de Phase II en cours évaluant lanifibranor chez des patients atteints de diabète de type 2 (T2DM) et de stéatose hépatique non alcoolique (NAFLD)
- A la suite des effets plus importants que prévus concernant la réduction de la stéatose lors de l'étude de Phase IIb NATIVE dans la NASH, le...
- 07/06/2020
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Intercept Pharmaceuticals: Regulatory Snub Unsettles Liver Therapy Front-Runner
- The FDA decision has wiped out more than a third of Intercept’s market cap. Yet, the company remains the front runner in the NASH space. The current trading mul
- 07/05/2020
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Geode Capital Management LLC Increases Stock Position in Madrigal Pharmaceuticals Inc (NASDAQ:MDGL)
- Geode Capital Management LLC lifted its holdings in shares of Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) by 12.1% during the first quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The institutional investor owned 138,920 shares of the biopharmaceutical company’s stock after buying an additional 14,987 shares during the quarter. Geode Capital […]
- 07/03/2020
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B.Riley FBR Sticks to Its Buy Rating for Spectrum Pharmaceuticals (SPPI) - Markets
- B.Riley FBR analyst Mayank Mamtani reiterated a Buy rating on Spectrum Pharmaceuticals (SPPI – Research Report) today and set a
- 07/02/2020
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89bio (ETNB) Receives a Buy from Oppenheimer - Markets
- Oppenheimer analyst Jay Olson maintained a Buy rating on 89bio (ETNB – Research Report) today and set a price target
- 07/02/2020
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Tower Research Capital LLC TRC Increases Holdings in Madrigal Pharmaceuticals Inc (NASDAQ:MDGL)
- Tower Research Capital LLC TRC lifted its position in shares of Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) by 477.1% during the 1st quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The institutional investor owned 958 shares of the biopharmaceutical company’s stock after acquiring an additional 792 shares during the quarter. Tower […]
- 07/02/2020
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ABIONYX Pharma: Monthly Statement of Total Voting Rights and Shares Forming the Company’s Share Capital
- Regulatory News: ABIONYX Pharma (Paris:ABNX): Market: Euronext Paris, Compartment C ISIN code: FR0012616852 Date Number of shares outstanding Total vo
- 07/02/2020
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Should You Throw in the Towel on Intercept Pharmaceuticals After Its Big Setback? | The Motley Fool
- An approval pathway for OCA in treating NASH still exists. But it appears to be a steeper path.
- 07/01/2020
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Analysts Offer Insights on Healthcare Companies: Catasys (NASDAQ: CATS), Akero Therapeutics (NASDAQ: AKRO) and Zynerba Pharmaceuticals (NASDAQ: ZYNE) - Markets
- There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Catasys (CATS
- 07/01/2020
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Entasis Therapeutics Holdings (ETTX) Receives a Buy from H.C. Wainwright - Markets
- H.C. Wainwright analyst Ed Arce maintained a Buy rating on Entasis Therapeutics Holdings (ETTX – Research Report) today and set
- 07/01/2020
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Analysts Offer Insights on Healthcare Companies: ObsEva SA (NASDAQ: OBSV), Akero Therapeutics (NASDAQ: AKRO) and Eyenovia (NASDAQ: EYEN) - Markets
- There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on ObsEva SA
- 07/01/2020
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Stocks to watch: Voda Idea, ONGC, Airtel, autos, HUL, JSPL, Future Grp stks
- Here's a look at the top stocks that may remain in focus today
- 07/01/2020
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Oppenheimer Reaffirms Their Buy Rating on Marinus (MRNS) - Markets
- Oppenheimer analyst Jay Olson maintained a Buy rating on Marinus (MRNS – Research Report) yesterday and set a price target
- 07/01/2020
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INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Intercept Pharmaceuticals, Inc. and Encourages Investors with Losses of $100,000 to Contact the Firm
- INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Intercept Pharmaceuticals, Inc.
- 07/01/2020
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GENFIT : Résultats de l'assemblée générale ordinaire du 30 juin 2020 | Zone bourse
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Analysts Are Downgrading Intercept Pharmaceuticals. Here’s Why.
- Uncertainty over its NASH drug weighs on the stock.
- 06/30/2020
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ENDRA Life Sciences Submits 510(k) Application to the US FDA for TAEUS(R) Liver Device | | IT Business Net
- Regulatory submission marks another major step toward commercialization of TAEUS liver device in 2020 ANN ARBOR, MI / ACCESSWIRE / June 30, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:
- 06/30/2020
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Grassley Says Talks On Drug Pricing Bill Are Broken, Pledges To Push GOP Bill Through Senate
- The Iowa senator’s comments could signal that there is little chance for a bill this year that would rein in drug prices, a policy that voters have expressed keen interest in.
- 06/30/2020
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Intercept CEO lays into FDA after NASH drug rejection -
- Intercept Pharmaceuticals has accused the FDA of moving the goalposts during its review of a potential blockbuster drug for the fatty liver disease known as NASH following a rejection.
- 06/30/2020
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Analysts Offer Insights on Healthcare Companies: Cryolife (NYSE: CRY) and Seattle Genetics (NASDAQ: SGEN) - Markets
- There’s a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Cryolife (CRY
- 06/30/2020
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Legend Biotech (NASDAQ:PLRX) Now Covered by Analysts at Piper Sandler
- Piper Sandler assumed coverage on shares of Legend Biotech (NASDAQ:PLRX) in a research note issued to investors on Monday morning, BenzingaRatingsTable reports. The brokerage issued an overweight rating and a $50.00 target price on the stock. Shares of PLRX opened at $35.26 on Monday. Legend Biotech has a 12 month low of $21.05 and a […]
- 06/30/2020
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Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Intercept Pharmaceuticals, Inc. (ICPT) on Behalf of Investors | | IT Business Net
- LOS ANGELES--(BUSINESS WIRE)--$ICPT #fraud--Glancy Prongay & Murray LLP ("GPM"), a leading national shareholder rights law firm, today announced that it has commenced an investigation on
- 06/30/2020
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Dow Surges 2.3% as Boeing Begins Testing the 737 Max
- Stocks Analysis by Zacks Investment Research covering: Boeing Co, Ciena Corp, Lennar Corporation, Verizon Communications Inc. Read Zacks Investment Research's latest article on Investing.com
- 06/30/2020
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Hepion Pharmaceuticals Announces Advancement to Final Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431 | | IT Business Net
- EDISON, NJ / ACCESSWIRE / June 29, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease ari
- 06/29/2020
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Intercept Drops as FDA Refuses Speedy Approval of Liver Drug - BNN Bloomberg
- Intercept Pharmaceuticals Inc. shares plummeted Monday as U.S. regulators dashed hopes for an accelerated approval of what investors thought would be the first medicine to treat tens of millions of people with a deadly liver disease.
- 06/29/2020
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Intercept Shares Tumble on NASH Disappointment
- Questions about drugs aimed at treating the liver disease have been bubbling up for months.
- 06/29/2020
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Oil futures climb, with U.S. prices up more than 3%
- Oil futures climbed on Friday, with U.S. prices up by more than 3%, finding support from some recovery in energy demand, even as that recovery is threatened...
- 06/29/2020
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Xconomy: FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data
- The FDA has rejected an Intercept Pharmaceuticals drug developed to treat the fatty liver disorder nonalcoholic steatohepatitis, more commonly referred to
- 06/29/2020
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FDA turns down Intercept’s long-anticipated NASH drug
- The FDA has requested additional data from the company's clinical trial. Intercept's CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
- 06/29/2020
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Analysts Offer Insights on Healthcare Companies: Achieve Life Sciences (NASDAQ: ACHV) and Intercept Pharma (NASDAQ: ICPT) - Markets
- Analysts have been eager to weigh in on the Healthcare sector with new ratings on Achieve Life Sciences (ACHV –
- 06/29/2020
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Ecco perché oggi il prezzo delle azioni Intercept è crollato del 40% | Invezz
- Le azioni di Intercept Pharmaceuticals, Inc (Nasdaq: ICPT) sono precipitate di oltre il 40% dopo che la Food and Drug Administration (FDA) statunitense ha rifiutato di approvare il farmaco dell’azienda contro le malattie del fegato. Di conseguenza, il prezzo delle azioni Intercept è sceso a un minimo storico degli ultimi 7 anni. Analisi fondamentale: “Decisione prematura” dice il CEO Intercept, la società biofarmaceutica con sede negli Stati Uniti che sviluppa nuove terapie per il trattamento delle malattie del fegato, ha detto oggi che la FDA ha rifiutato di approvare il suo farmaco per le malattie croniche del fegato. La società
- 06/29/2020
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Heron Therapeutics (HRTX) Initiated with a Buy at Stifel Nicolaus - Markets
- Stifel Nicolaus analyst Derek Archila initiated coverage with a Buy rating on Heron Therapeutics (HRTX – Research Report) today and
- 06/29/2020
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Here’s why Intercept stock price collapsed 40% today | Invezz
- Shares of Intercept Pharmaceuticals, Inc (Nasdaq: ICPT) plunged over 40% after the U.S. Food and Drug Administration (FDA) declined to approve the firm’s therapy for liver disease. As a result, Intercept share price trades at a 7-year low. Fundamental analysis: “Premature decision” says CEO Intercept, the US-based biopharma company developing novel therapeutics to treat liver diseases, said today that the FDA refused to approve its chronic liver disease therapy. The pharma company has submitted a New Drug Application (NDA) for obeticholic acid (OCA). This therapy is used to treat fibrosis – a chronic disease related to obesity, caused by non-alcoholic
- 06/29/2020
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FDA Tells Intercept Pharmaceuticals No on Its NASH Drug Candidate -- for Now | The Motley Fool
- The pharmaceutical company's attempt to get obeticholic acid approved for the lucrative non-alcoholic steatohepatitis market has hit a (perhaps temporary) roadblock.
- 06/29/2020
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Why Intercept Pharmaceuticals Stock Is Crashing Today | The Motley Fool
- Shares are taking a step back after the FDA rejected the company's NASH candidate.
- 06/29/2020
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Genfit : L'américain Intercept, rival de Genfit, se prend à son tour les pieds dans le tapis
- (BFM Bourse) - L'agence américaine du médicament a refusé d'homologuer l'Ocaliva (acide obéticholique) d'Intercept pour le traitement de la fibrose du foie …
- 06/29/2020
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Analyst Explains Why They Downgraded Their Rating on Intercept Pharma (ICPT) - Markets
- In a report released today, Jay Olson from Oppenheimer downgraded Intercept Pharma (ICPT – Research Report) to Hold, with a
- 06/29/2020
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U.S. FDA declines to approve Intercept's NASH therapy; shares plunge
- The U.S. Food and Drug Administration declined to approve Intercept Pharmaceuticals Inc's therapy for a progressive liver disease, the company said on Monday, sending its shares down 37% before the bell.
- 06/29/2020
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FDA rejects Intercept Pharma's drug for fatty liver disease
- Intercept Pharmaceuticals said Monday that the Food and Drug Administration rejected its drug to treat the fatty liver disease known as NASH.
- 06/29/2020
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Enanta Pharmaceuticals Announces the Appointment of Mark G. Foletta to Its Board of Directors | | IT Business Net
- WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases
- 06/29/2020
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Wall Street : Les valeurs à suivre à Wall Street
- PARIS (Reuters) - Principales valeurs à suivre lundi à Wall Street, où les contrats à terme sur indices suggèrent une ouverture en hausse de 0,5% environ …
- 06/29/2020
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USA-Les valeurs à suivre à Wall Street (actualisé)
- (Actualisé avec Facebook, Twitter et Snap, annonce de Coty,
Intercept Pharmaceuticals, Gilead, cours en avant-Bourse)
PARIS, 29 juin (Reuters) - Principales valeurs à suivre
lundi à Wall Street, où les contrats à terme sur indices
suggèrent une ouverture en hausse de 0,5% environ pour le Dow
Jones .DJI et de 0,2% pour le Standard & Poor's 500
- 06/29/2020
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Intercept Pharmaceuticals receives FDA Complete Response Letter for treatment for fibrosis due to NASH
- Intercept Pharmaceuticals Inc. shares undefined tumbled more than 30% in premarket trade Monday, after the company said it has received a U.S. Food and Drug...
- 06/29/2020
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Legend Biotech (NASDAQ:PLRX) Reaches New 12-Month High at $32.79
- Shares of Legend Biotech Corporation (NASDAQ:PLRX) hit a new 52-week high on Monday . The company traded as high as $32.79 and last traded at $32.75, with a volume of 445 shares trading hands. The stock had previously closed at $31.72. Several equities research analysts recently weighed in on the stock. Citigroup initiated coverage on […]
- 06/29/2020
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Durect (DRRX) Gets a Buy Rating from H.C. Wainwright - Markets
- In a report released today, Ed Arce from H.C. Wainwright maintained a Buy rating on Durect (DRRX – Research Report),
- 06/29/2020
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Cowen Initiates Coverage on Legend Biotech (NASDAQ:PLRX)
- Stock analysts at Cowen began coverage on shares of Legend Biotech (NASDAQ:PLRX) in a research report issued to clients and investors on Monday, BenzingaRatingsTable reports. The brokerage set an “outperform” rating on the stock. Other analysts also recently issued reports about the company. Piper Sandler initiated coverage on Legend Biotech in a research report on […]
- 06/29/2020
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Integrating Echosens’ FibroScan into MetaPhy’s Chronic Care Liver Disease Management Program Impacts Patient Outcomes, Costs, Financial Performance of Gastroenterology Practices
- Integrating Echosens’ FibroScan into MetaPhy’s Chronic Care Liver Disease Management Program Impacts Patient Outcomes, Costs, Financial Performance
- 06/29/2020
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Financial Comparison: GENFIT S A/ADR (GNFT) versus The Competition
- GENFIT S A/ADR (NASDAQ: GNFT) is one of 141 publicly-traded companies in the “Biological products, except diagnostic” industry, but how does it contrast to its peers? We will compare GENFIT S A/ADR to similar companies based on the strength of its institutional ownership, risk, profitability, dividends, analyst recommendations, valuation and earnings. Institutional and Insider Ownership […]
- 06/28/2020
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Should You Avoid Madrigal Pharmaceuticals, Inc. (MDGL)?
- In this article you are going to find out whether hedge funds think Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) is a good investment right now. We like to check what the smart money thinks first before doing extensive research on a given stock. Although there have been several high profile failed hedge fund picks, the consensus picks […]
- 06/28/2020
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Inventiva SA Starts U.S. IPO Rollout
- Inventiva SA has filed to raise $90 million in a U.S. IPO. The firm is advancing a pipeline of treatment candidates for NASH, MPS and other diseases. IVA is pre
- 06/26/2020
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Madrigal Pharmaceuticals (NASDAQ:MDGL) Rating Reiterated by Oppenheimer
- Madrigal Pharmaceuticals (NASDAQ:MDGL)‘s stock had its “buy” rating restated by stock analysts at Oppenheimer in a research report issued to clients and investors on Wednesday, AnalystRatings.com reports. They currently have a $200.00 price target on the biopharmaceutical company’s stock. Oppenheimer’s price objective suggests a potential upside of 80.65% from the stock’s previous close. Several other […]
- 06/26/2020
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GENFIT S A/ADR (GNFT) versus Its Rivals Head to Head Contrast
- GENFIT S A/ADR (NASDAQ: GNFT) is one of 141 publicly-traded companies in the “Biological products, except diagnostic” industry, but how does it compare to its rivals? We will compare GENFIT S A/ADR to similar businesses based on the strength of its valuation, analyst recommendations, dividends, earnings, profitability, risk and institutional ownership. Risk & Volatility GENFIT […]
- 06/26/2020
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The Daily Biotech Pulse: Chiasma, Heron Await FDA Decisions, DBV Restructures, 3 Biopharmas Make Wall Street Debuts
- Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs June 25)
Brainstorm Cell...
- 06/26/2020
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F&O: Nifty50 forms lower lows, but showing a lot of resilience
- India VIX moved up 0.51% from 29.57 to 29.73 level.
- 06/25/2020
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Poxel : annonce les résultats de son Assemblée générale ordinaire annuelle et extraordinaire du 24 juin 2020 | Zone bourse
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What Algernon is doing to potentially combat COVID-19
- Algernon Pharmaceuticals Inc. (CSE: AGN | OTCQB: AGNPF | FSE: AGW) is a clinical stage drug development company focused on the areas of non–alcoholic steatohepatitis (NASH), chronic kidney di…
- 06/25/2020
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Tetraphase (TTPH) Gets a Hold Rating from H.C. Wainwright - Markets
- H.C. Wainwright analyst Ed Arce maintained a Hold rating on Tetraphase (TTPH – Research Report) today. The company’s shares closed
- 06/25/2020
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H.C. Wainwright Initiates a Hold Rating on Intercept Pharma (ICPT) - Markets
- In a report released today, Ed Arce from H.C. Wainwright initiated coverage with a Hold rating on Intercept Pharma (ICPT
- 06/25/2020
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Poxel annonce les résultats de son Assemblée générale ordinaire annuelle et extraordinaire du 24 juin 2020
- Regulatory News : POXEL SA (Paris:POXEL) (Euronext : POXEL - FR0012432516), société biopharmaceutique spécialisée dans le développement de traitements
- 06/25/2020
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Stifel Nicolaus Believes Momenta Pharma (NASDAQ: MNTA) Won't Stop Here - Markets
- Stifel Nicolaus analyst Derek Archila reiterated a Buy rating on Momenta Pharma (MNTA – Research Report) today. The company’s shares
- 06/24/2020
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Combination Pill From Myovant Reduces Pain From Endometriosis, Trial Shows
- Read about the biggest pharmaceutical development and pricing stories from the past week in KHN’s Prescription Drug Watch roundup.
- 06/24/2020
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Advocates Want More Warnings From FDA On Diabetes Drug Linked To Fatal Reactions
- Because the drug can cause a potentially fatal condition called ketoacidosis in diabetic patients, advocates are calling on the FDA to issue a “black box” warning–the most severe …
- 06/24/2020
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Poxel : premiers résultats positifs dans la NASH | Zone bourse
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Poxel : annonce des résultats positifs de son étude pharmacocinétique (PK) / pharmacodynamique (PD) pour le PXL770, un activateur direct de l'AMPK pour le traitement de la NASH | Zone bourse
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Poxel annonce des résultats positifs de son étude pharmacocinétique (PK) / pharmacodynamique (PD) pour le PXL770, un activateur direct de l'AMPK pour le traitement de la NASH
- Pour recevoir l'information de POXEL en temps réel, faites-en la demande à poxel@newcap.eu
- 06/24/2020
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Critical Contrast: GENFIT S A/ADR (GNFT) and Its Peers
- GENFIT S A/ADR (NASDAQ: GNFT) is one of 141 publicly-traded companies in the “Biological products, except diagnostic” industry, but how does it contrast to its peers? We will compare GENFIT S A/ADR to related companies based on the strength of its valuation, dividends, analyst recommendations, risk, earnings, institutional ownership and profitability. Analyst Ratings This is […]
- 06/24/2020
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Poxel Announces Positive Pharmacokinetic (PK) / Pharmacodynamic (PD) Study Results for PXL770, a Direct AMPK Activator for the Treatment of NASH
- POXEL SA (Euronext: POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, in
- 06/24/2020
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ENDRA Life Sciences Expands IP Portfolio to 72 with Addition of Key Patents | | IT Business Net
- Two Newly Issued Patents Further Protect ENDRA's TAEUS Platform Capabilities ANN ARBOR, MI / ACCESSWIRE / June 23, 2020 / ENDRA Life Sciences Inc. (''ENDRA'') (NASDAQ:NDRA), a
- 06/23/2020
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Fate of Intercept's NASH drug clouded by murky FDA review delays
- The agency had planned to announce its decision on whether or not to approve the first treatment for the fatty liver disease known as NASH this week.
- 06/23/2020
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Two Sigma Investments LP Purchases 15,717 Shares of Madrigal Pharmaceuticals Inc (NASDAQ:MDGL)
- Two Sigma Investments LP raised its position in shares of Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) by 698.5% in the first quarter, according to the company in its most recent filing with the Securities & Exchange Commission. The institutional investor owned 17,967 shares of the biopharmaceutical company’s stock after purchasing an additional 15,717 shares during the period. […]
- 06/23/2020
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Ayala Pharmaceuticals (AYLA) Receives a Buy from Oppenheimer - Markets
- In a report released yesterday, Jay Olson from Oppenheimer maintained a Buy rating on Ayala Pharmaceuticals (AYLA – Research Report),
- 06/23/2020
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The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout
- The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs June 22)
ADC Therapeutics SA (...
- 06/23/2020
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