Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome Measures
- LAVAL, Québec, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that it will host a conference call on Tuesday, January 10, 2023 at 4:30 p.m. ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102. Both studies successfully met all target outcome measures.
- 01/05/2023
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Best Penny Stocks To Buy Now? 4 Stocks Under $4 To Watch
- Penny stocks to watch this week. The post Best Penny Stocks To Buy Now?
- 12/28/2022
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Acasti Pharma Inc. (ACST) Q2 2023 Earnings Call Transcript
- Acasti Pharma Inc. (NASDAQ:ACST ) Q2 2023 Earnings Conference Call November 14, 2022 1:00 PM ET Company Participants Robert Blum - Lytham Partners, IR Jan D'Alvise - President & CEO Brian Ford - CFO Prashant Kohli - Chief Commercial Officer Conference Call Participants Leland Gershell - Oppenheimer Sahil Kazmi - B. Riley Securities Operator Good day, and welcome to the Acasti Pharma Second Quarter 2023 Earnings Event Call.
- 11/14/2022
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Acasti Pharma to Present at Q4 Investor Summit
- LAVAL, Québec, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Jan D'Alvise, President and CEO of Acasti Pharma will be presenting virtually at the Q4 Investor Summit. The Company will be conducting a webcasted presentation and participating in one-on-one meetings with investors.
- 11/09/2022
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Acasti Pharma to Report Second Quarter 2023 Financial Results on Monday, November 14, 2022
- Call to be held on Monday, November 14th at 1:00 PM Eastern Time Call to be held on Monday, November 14th at 1:00 PM Eastern Time
- 11/07/2022
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Acasti Pharma to Participate in the Lytham Partners Fall 2022 Investor Conference
- LAVAL, Québec, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company with drug delivery capability and technologies addressing rare and orphan diseases, announced today that it will be participating in the Lytham Partners Fall 2022 Investor Conference taking place virtually on September 28-29, 2022.
- 09/14/2022
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Acasti Pharma to Participate at the H.C. Wainwright 24th Annual Global Investment Conference
- LAVAL, Québec, Sept. 12, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company with drug delivery capability and technologies addressing rare and orphan diseases, today announced that management will virtually participate at the H.C. Wainwright 24th Annual Global Investment Conference September 12-16, 2022.
- 09/12/2022
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Acasti Pharma to Report First Quarter 2023 Financial Results on Thursday, August 11, 2022
- Call to be held on Thursday, August 11th at 1:00 PM Eastern Time
- 08/02/2022
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Acasti Pharma Schedules Fiscal Year 2022 Business Update Conference Call
- Call to be held on Tuesday, June 21st at 1:00 PM Eastern Time Call to be held on Tuesday, June 21st at 1:00 PM Eastern Time
- 06/16/2022
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Acasti Pharma's IV Hemorrhage Drug Candidate At Par With Oral Nimodipine
- Acasti Pharma Inc's (NASDAQ: ACST) pharmacokinetic (PK) bridging study with IV GTX-104, its lead drug candidate for Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The study's primary objective was to evaluate the relative bioavailability of IV GTX-104.
- 05/18/2022
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Penny Stocks To Buy Now? 6 To Watch Under $1 This Week
- Penny stocks to watch under $1 today. The post Penny Stocks To Buy Now?
- 05/18/2022
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Acasti Pharma to Present at the B. Riley Securities' 2022 Virtual Neuro & Ophthalmology Conference on April 28th
- LAVAL, Québec, April 25, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announced that Prashant Kohli, Vice President of Commercial Operations of Acasti Pharma will be presenting at the B. Riley Securities' 2022 Virtual Neuro & Ophthalmology Conference on Thursday, April 28, 2022 at 4:30 pm ET.
- 04/25/2022
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Acasti Pharma CEO to Present at the 32nd Annual Oppenheimer Healthcare Conference on March 16th
- LAVAL, Quebec, March 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announced that Jan D'Alvise, President and Chief Executive Officer of Acasti Pharma will be presenting at the 32nd Annual Oppenheimer Healthcare conference being held virtually March 15-17, 2022.
- 03/09/2022
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New Strong Sell Stocks for February 23rd
- ARR, ACST, and ATUS have been added to the Zacks Rank #5 (Strong Sell) List on February 23, 2022
- 02/23/2022
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Acasti Pharma Inc. (ACST) CEO Jan D'Alvise on Q3 2021 Results - Earnings Call Transcript
- Acasti Pharma Inc. (ACST) CEO Jan D'Alvise on Q3 2021 Results - Earnings Call Transcript
- 02/14/2022
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Acasti Pharma Schedules Third Quarter Fiscal 2022 Business Update Conference Call
- Call to be held on Monday, February 14th at 1:00 PM Eastern Time Call to be held on Monday, February 14th at 1:00 PM Eastern Time
- 02/07/2022
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Acasti Pharma to Present at the H.C. Wainwright BioConnect 2022 Conference
- LAVAL, Québec, Jan. 03, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announced that Jan D'Alvise, President and CEO of Acasti, will be presenting at the H.C. Wainwright BioConnect 2022 Conference being held virtually January 10-13, 2022.
- 01/03/2022
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Acasti Pharma Stock (ACST): Why The Price Surged
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) increased by 52.25% in the previous trading session. This is why it happened.
- 12/23/2021
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ACST Stock Price Predictions: Why One Analyst Sees Acasti Rocketing to $6
- After an Oppenheimer upgrade, shares of ACST stock are soaring higher by more than 25%. Why exactly is the investment firm bullish?
- 12/22/2021
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Best Penny Stocks to Watch as the Market Takes a Bullish Turn
- Are any of these penny stocks on your watchlist right now? The post Best Penny Stocks to Watch as the Market Takes a Bullish Turn appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 12/22/2021
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See Why Acasti Pharma Shares Are Trading Over 20% Higher?
- Oppenheimer initiated coverage of Acasti Pharma Inc (NASDAQ: ACST) with an Outperform rating and $6 price target. The analyst sees over 400% upside for the stock.
- 12/22/2021
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Acasti Pharma To Present At The Q4 Investor Summit on November 16th
- Laval, Quebec--(Newsfile Corp. - November 11, 2021) - Acasti Pharma Inc. (NASDAQ: ACST) (TSXV: ACST) ("Acasti" or the "Company"), today announced that management will present at the Q4 Investor Summit, hosted by the Investor Summit Group, being held virtually on November 16-17, 2021. Jan D'Alvise, President and Chief Executive Officer of Acasti Pharma, is scheduled to present as follows:Event: Q4 Investor SummitDate and Time: Tuesday, November 16 at 3:30 pm Eastern TimeWebcast: https://us06web.zoom.us/webinar/register/WN_Wf9K_2n0QoO3WVYfML50_gA replay of the...
- 11/11/2021
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Acasti Pharma Inc. (ACST) CEO Jan D'Alvise on Q3 2021 Results - Earning Call Transcript
- Acasti Pharma Inc. (ACST) CEO Jan D'Alvise on Q3 2021 Results - Earning Call Transcript
- 11/10/2021
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Acasti Pharma Awarded Composition-of-Matter Patents for GTX-101 in Europe, China and Mexico and for GTX-102 in Japan
- Patents strengthen Acasti's IP portfolio and provide protection through 2036 and 2037, respectively Patents strengthen Acasti's IP portfolio and provide protection through 2036 and 2037, respectively
- 10/06/2021
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Acasti Pharma Announces Initiation of Pharmacokinetic Bridging Study for GTX-104, the Company's Lead Drug Candidate for the Treatment of Subarachnoid Hemorrhage
- Study expected to be completed in the first half of 2022, with the goal to commence the Phase 3 safety study in the second half of 2022 Study expected to be completed in the first half of 2022, with the goal to commence the Phase 3 safety study in the second half of 2022
- 09/27/2021
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Acasti Pharma Provides Update Following Acquisition of Grace Therapeutics and Regains Compliance with Nasdaq Listing Standards
- LAVAL, Québec, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today provided a business update and announced that the Nasdaq Stock Market (“Nasdaq”) has confirmed to Acasti that the Company has regained compliance with Nasdaq's minimum bid price requirement.
- 09/22/2021
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Acasti Pharma to Present at the Oppenheimer Fall Healthcare Summit on September 21ˢᵗ
- LAVAL, Québec, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announced that it will be presenting at the Oppenheimer Fall Healthcare Summit being held virtually September 20-23, 2021.
- 09/14/2021
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Why Shares of Acasti Pharma Slumped Tuesday
- The clinical-stage pharmaceutical company completed its merger with Grace Therapeutics last week.
- 08/31/2021
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Acasti Pharma Announces Successful Completion of its Merger with Grace Therapeutics, Inc., Voting Results of its Annual and Special Meeting of Shareholders and Reverse Stock Split
- LAVAL, Québec, Aug. 27, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti”) (NASDAQ: ACST–TSX-V: ACST), announced today the completion of its previously disclosed acquisition of Grace Therapeutics, Inc. (“Grace”) via merger. The successful completion of the merger positions Acasti to build a premier, late-stage specialty pharma company focused on rare diseases. Based on management's current forecasts, Acasti expects to have enough cash on its balance sheet following the merger to provide at least two years of operating runway. The combined companies will be led by Jan D'Alvise as President and Chief Executive Officer, under the oversight of Acasti's newly elected Board of Directors, comprised of four re-elected directors of Acasti and two Grace nominees newly elected as directors (with a third Grace nominee expected to be nominated prior to the next annual meeting of shareholders). All Grace employees will transition to Acasti and they will continue to maintain a research and development laboratory and commercial presence in North Brunswick, New Jersey.
- 08/27/2021
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Are These Penny Stocks on Your Watchlist Right Now?
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- 08/12/2021
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Reminder: Acasti Pharma to Host Conference Call on August 4th at 1:00 PM ET to Discuss Planned Acquisition of Grace Therapeutics
- LAVAL, Québec, July 29, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announces a reminder that it will host a business update conference call on Wednesday, August 4th at 1:00 PM ET to discuss the planned acquisition of Grace Therapeutics, Inc. (“Grace”), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases, as well as topics related to the annual and special meeting of shareholders. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to ACST@crescendo-ir.com.
- 07/29/2021
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Best Penny Stocks to Buy in August? 4 for Your Watchlist
- Which penny stocks are investors watching with August only a week away? The post Best Penny Stocks to Buy in August?
- 07/24/2021
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Acasti Pharma Schedules Conference Call for August 4th at 1:00 PM ET to Discuss Planned Acquisition of Grace Therapeutics
- All shareholders are strongly encouraged to vote in advance of the August 26, 2021, annual and special meeting of shareholders All shareholders are strongly encouraged to vote in advance of the August 26, 2021, annual and special meeting of shareholders
- 07/23/2021
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ACST Stock Increases Over 10% Pre-Market: Why It Happened
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) increased by over 10% pre-market. This is why it happened.
- 07/14/2021
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Best Biotech Penny Stocks to Buy in July 2021? 6 For Your Watchlist
- Biotech penny stocks are in focus; here's 4 to watch right now The post Best Biotech Penny Stocks to Buy in July 2021? 6 For Your Watchlist appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 07/12/2021
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5 Hot Penny Stocks You Need to Know About in 2021
- Are these top penny stocks worth watching in July 2021? The post 5 Hot Penny Stocks You Need to Know About in 2021 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 07/11/2021
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Best Biotech Penny Stocks In Summer 2021? 7 For Your Watchlist
- Are these the best biotech penny stocks to watch right now? The post Best Biotech Penny Stocks In Summer 2021?
- 07/01/2021
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What Penny Stocks to Buy Today? 7 Small-Caps to Watch Right Now
- Which penny stocks are on your watchlist today? Here's 7 for some inspiration The post What Penny Stocks to Buy Today?
- 06/23/2021
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ACST Stock Price Increases Over 35% Pre-Market: Why It Happened
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) increased by over 35% pre-market. This is why it happened.
- 06/23/2021
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Reddit Penny Stocks to Buy? 7 You Need to Know About In July
- Looking for the best penny stocks to watch in July? Check these 7 out for your list The post Reddit Penny Stocks to Buy?
- 06/22/2021
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Acasti Pharma reduces losses as it progresses Grace Therapeutics transaction
- Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) (FRA:A1PA) announced its operating and financial results for the fiscal year ended 31 March, along with an update on its proposed acquisition of Grace Therapeutics. Acasti, a biopharmaceutical innovator, reported a narrower loss from operating activities of $16.4 million, compared to a loss of $24.4 million a year earlier, due mainly to a reduction in expenses.
- 06/22/2021
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Biotech Penny Stocks Pushing Up During The Crypto Crash, One Up 25%
- Best biotech penny stocks to buy during the crypto crash? Check these 3 out The post Biotech Penny Stocks Pushing Up During The Crypto Crash, One Up 25% appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 05/19/2021
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Acasti Intends to Request Hearing Before Nasdaq Panel to Present Plan of Compliance
- LAVAL, Québec, May 17, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) today announced that, on May 11, 2021, the Company received notice from the Nasdaq Listing Qualifications Department (the “Staff”) indicating that, based upon the Company's non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a) (the “Rule”) as of May 10, 2021, the Company's securities were subject to delisting unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company has previously disclosed and expected such notification from Nasdaq and believes it has options to regain compliance, preferably in connection with its proposed acquisition of Grace Therapeutics, Inc. (“Grace”) as is often done in connection with similar transactions.
- 05/17/2021
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ACASTI PHARMA INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Merger of Acasti Pharma Inc. - ACST
- NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed merger of Acasti Pharma Inc. (“Acasti” or the “Company”) (NasdaqGS: ACST) with Grace Therapeutics Inc., pursuant to which Acasti shareholders will end up owning only approximately 55% of the combined company. KSF is seeking to determine whether the merger and the process that led to it are adequate, or whether the mer
- 05/12/2021
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ACST Stock: Over 4% Increase Pre-Market Explanation
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) increased by over 4% pre-market. This is why it happened.
- 05/10/2021
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Acasti Pharma Falls To Support, Stages Huge Rebound
- Shares of Acasti Pharma, Inc. (NASDAQ:ACST) fell to the 40-cent support level. Then they rallied and hit resistance at the 58 cents level and are selling off again.
- 05/07/2021
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Acasti Pharma unveils proposal to buy Grace Therapeutics and its portfolio of drug candidates in all-stock deal
- Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) has announced a definitive agreement to acquire Grace Therapeutics Inc, a privately-held biopharmaceutical company developing drug delivery technologies for the treatment of rare and orphan diseases. The deal would have Acasti acquire Grace's entire therapeutic pipeline consisting of three unique clinical stage and multiple preclinical stage assets, supported by an intellectual property portfolio of more than 40 granted and pending patents globally.
- 05/07/2021
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3 Penny Stocks That Investors Need to Watch In 2021
- Which penny stocks should you know about in 2021? Take a look at these 3 The post 3 Penny Stocks That Investors Need to Watch In 2021 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 05/07/2021
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ACST Stock: Over 10% Increase Pre-Market Explanation
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) increased by over 10% pre-market. This is why it happened.
- 05/07/2021
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Acasti Announces Definitive Agreement to Acquire Grace Therapeutics, Inc.
- Grace provides Acasti with a pipeline of rare and orphan disease programs, including 3 clinical stage assets that have received Orphan Drug Designation from the FDA
- 05/07/2021
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Best Penny Stocks to Buy Under $2? Check These 3 Out
- Are penny stocks under $2 worth it? Take a look at these 3 to decide The post Best Penny Stocks to Buy Under $2?
- 04/26/2021
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Acasti Pharma Stock Is Only Ideal for a Short-Term Trade
- From time to time, ACST stock tends to have massive price spikes. It's too volatile for a long-term position, but may be a trader's paradise.
- 03/17/2021
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Acasti Pharma Provides Update on Recent Financing Activities
- LAVAL, Quebec, March 08, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) is providing an update on the use of its “at-the market” equity offering program.
- 03/08/2021
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Acasti Pharma awaiting business review outcome after CaPre drug trial disappointment
- TRILOGY 2 study on CaPre did not meet its primary endpoint CaPre was a krill-oil derived prescription drug designed to treat hypertriglyceridemia What Acasti Pharma does: Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) had been developing a krill-oil derived prescription drug called CaPre to treat hypertriglyceridemia (high levels of triglycerides in the blood), which is known to contribute to heart disease. However, in August last year, the company revealed that a TRILOGY 2 study on CaPre had not met its primary endpoint and said it would not file a New Drug Application with the US Food and Drug Administration.
- 02/23/2021
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ACST Stock Price Increases Over 30% Pre-Market: Why It Happened
- The stock price of Acasti Pharma Inc (NASDAQ: ACST – TSX-V: ACST) is trading at over 30% pre-market as of 6:02 AM ET. This is why it happened.
- 02/10/2021
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Why Corcept Therapeutics, Acasti Pharma And More Are Moving Today
- Corcept Therapeutics (NASDAQ: CORT) shares were trading lower Tuesday after the company reported preliminary fourth-quarter sales results and issued fiscal year 2021 sales guidance. Corcept Therapeutics Inc is engaged in the discovery, development, and commercialization of drugs for the treatment of severe metabolic, psychiatric and oncologic disorders by modulating the effects of cortisol.
- 02/09/2021
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Acasti Pharma posts fiscal third quarter results as strategic review continues
- Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) (FRA:A1PA), which is currently going through a review process aimed at enhancing shareholder value, posted Tuesday its fiscal third-quarter results to end-December last year. In the statement, the biopharma said it believes it has enough cash to fund it through this process, or at least the next 12 months.
- 02/09/2021
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Acasti Pharma Announces Results for Third Quarter of Fiscal 2021
- LAVAL, Quebec, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today announced its operating and financial results for the third quarter of fiscal 2021 ended December 31, 2020.
- 02/09/2021
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ACST Stock Price Increases Over 12% Pre-Market: Why It Happened
- The stock price of Acasti Pharma Inc (NASDAQ: ACST) is trading at over 12% pre-market. This is why it happened.
- 01/28/2021
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Acasti Pharma Provides Update on Recent Financing Activities
- LAVAL, Québec, Jan. 27, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) is providing an update on the use of its “at-the market” equity offering program.
- 01/27/2021
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ACST Stock Alert: 13 Things for Acasti Pharma Investors to Know as Shares Rocket Monday
- Acasti Pharma (ACST) stock is on the rise Monday with heavy trading of its shares despite a lack of news concerning the company. The post ACST Stock Alert: 13 Things for Acasti Pharma Investors to Know as Shares Rocket Monday appeared first on InvestorPlace.
- 01/11/2021
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Acasti (ACST) Moves to Buy: Rationale Behind the Upgrade
- Acasti (ACST) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
- 12/25/2020
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Acasti Pharma Unaware of Any Material Change
- LAVAL, Québec, Dec. 23, 2020 (GLOBE NEWSWIRE) -- At the request of IIROC, Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) wishes to confirm that the Company's management and Board of Directors are unaware of any material change in the Company's operations that would account for the recent increase in market activity.
- 12/23/2020
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ACST Stock: 13 Things to Know as Acasti Pharma Shares Soar 100%
- ACST stock is up more than 100% on Wednesday without any news about Acasti Pharma. Here's what you should know.
- 12/23/2020
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Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021
- LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.
- 11/16/2020
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What Makes Acasti (ACST) a New Buy Stock
- Acasti (ACST) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank 2 (Buy).
- 08/14/2020
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Acasti Pharma Provides Business Update for the First Quarter of Fiscal 2021
- On track to report TRILOGY 2 topline data on or about August 31, 2020LAVAL, Quebec, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today provided a business update and announced its operating and financial results for the first quarter of fiscal 2021 ended June 30, 2020. Corporate Highlights: * Finalized and submitted TRILOGY 2 Statistical Analyses Plan (“SAP”) to the FDA on July 31, 2020 * Provided business update, on June 29, 2020, in which the Company identified “Triglyceride Normalization” phenomenon prior to patient randomization and treatment as likely contributor to unusually high placebo effect in TRILOGY 1; post-hoc analyses revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo); meaningful efficacy trend for CaPre was observed after correcting for the unexpectedly large placebo response in the original analysis * Received a Notice of Allowance for second composition of matter patent to be awarded by the Canadian Intellectual Property Office, expanding the Company’s existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids. * Received a notice of issuance of a composition of matter patent to be awarded by the Intellectual Property Office in Hong Kong granting claims for any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids * TRILOGY 2 topline results expected on or about August 31, 2020 * Update on the timing for reporting the key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, will be provided after TRILOGY 2 results are reportedAs previously reported, the Company, along with the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, conducted rigorous post-hoc analysis of TRILOGY 1 data. These analyses revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo), which Acasti refers to as “Pre-randomization Triglyceride (TG) Normalization.” This artefactual phenomenon affected both treatment groups, but was much greater in the placebo group, resulting in the large placebo effect and significant underestimation of the post-randomization treatment effect of the active drug, CaPre. The post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4) corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by the normalization phenomenon, and a meaningful efficacy trend for CaPre was observed.The Company provided all of the TRILOGY 1 background information and accompanying data to the U.S. Food and Drug Administration (FDA) in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to the Company’s Type C Meeting request and briefing package, and confirmed that pivotal efficacy analyses for TRILOGY 2 will be performed on the full Intent to Treat (ITT) population, as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes.After reviewing feedback from the FDA and from key experts including Dr. Mozaffarian, Acasti finalized the SAP for TRILOGY 2, and submitted it to the FDA on July 31, 2020. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020. An update on the timing for reporting the key secondary and exploratory endpoints from both the TRILOGY 1 and TRILOGY 2 trials, as well as pooled results from both studies, will be provided after TRILOGY 2 results are reported. Jan D’Alvise, President and CEO of Acasti, commented, “With the TRILOGY 2 SAP finalized and now submitted to the FDA, we continue to advance the process towards unblinding of our TRILOGY 2 clinical data. We believe if TRILOGY 2 can achieve statistical significance, and if the pooled efficacy results with TRILOGY 1 using the Intent to Treat population also reaches significance, we can proceed with our Pre-NDA meeting where we intend to discuss with the FDA the use of this data to support an NDA filing. We look forward to the unblinding of TRILOGY 2 data and reporting our findings, concurrent with a conference call update on or about August 31, 2020.”As of June 30, 2020, Acasti had cash and cash equivalents totaling $12.1 million, compared to $16.0 million as of June 30, 2019. The Company believes it is sufficiently funded through the first calendar quarter of 2021, based on management’s current projections.First Quarter of Fiscal 2021 Financial Results (US dollars):The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). * Loss from operations for the three months ended June 30, 2020 was $4.1 million, compared to a loss from operations of $8.0 million for the three months ended June 30, 2019. The decrease was due mainly to a reduction in research contract expenses as the Phase 3 clinical program for CaPre was nearing completion. * Net loss for the three months ended June 30, 2020 was $4.7 million or $0.05 per share, compared to a net loss of $8.8 million or $0.11 per share for the three months ended June 30, 2019. The decreased net loss is primarily due to the reduction of research and development expenses as the Phase 3 clinical program for CaPre was nearing completion, lower net financial expenses, and the change in fair value of the warrants derivative liabilities. * R&D expenses before depreciation, amortization and stock-based compensation expenses were $1.1 million for the three months ended June 30, 2020, compared to $5.5 million for the three months ended June 30, 2019. The net decrease was mainly attributable to a reduction in research contract expense due to the advancement of the Phase 3 clinical trial program, as it moved closer to completion. * General and Administrative expenses before stock-based compensation expenses were $1.3 million for the three months ended June 30, 2020, an increase of $0.33 million from $0.97 million for the three months ended June 30, 2019. This increase was mainly attributable to consulting, accounting, and legal fees in connection with the conversion from IFRS to U.S. GAAP. * Sales and Marketing expenses before stock-based compensation expenses were $0.57 million for the three months ended June 30, 2020, compared to $0.68 million for the three months ended June 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a slowdown in pre-launch marketing activities pending the results of the TRILOGY Phase 3 clinical studies are obtained. The decrease was partially offset by an increase in salaries and benefits as a result of increased headcount in the commercial team to support expanded business and market development activities. * Cash and cash equivalents totaled $12.1 million as of June 30, 2020, compared to $16.0 million at June 30, 2019. As stated above, Acasti believes that current cash will fully fund the Company’s operations through the first calendar quarter of 2021. Acasti projects that additional funds will be needed in the future for activities necessary to prepare for the commercial launch of CaPre if regulatory approval is received, including the scale-up of its manufacturing operations, the completion of the potential regulatory NDA submission package (assuming positive Phase 3 clinical results), and the expansion of business development and U.S. commercial launch activities. The Company is working towards development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the near future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or non-dilutive financings. If the Company does not raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company’s ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business. Conference CallAcasti plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results, as well as to provide an update on the timing for the reporting of the secondary and exploratory endpoints, and the pooled results from both TRILOGY studies. Details for the call will be provided as we get closer to announcing TRILOGY 2 results. ATM UpdateOn June 29, 2020, Acasti entered into an amended and restated ATM sales agreement (the “Sales Agreement”) with B. Riley FBR Inc., Oppenheimer & Co. Inc. and H.C. Wainwright & Co., LLC (collectively, the “Agents”), to implement an “at-the-market” equity offering program under which Acasti may issue and sell from time to time our common shares having an aggregate offering price of up to $75 million through the Agents (the “ATM Program”).
- 08/13/2020
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Acasti Pharma Submits Statistical Analysis Plan to FDA and Remains On Track to Report TRILOGY 2 Topline Data On or About August 31, 2020
- LAVAL, Quebec, July 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced it has completed its revisions to the pre-specified Statistical Analysis Plan (SAP) for the TRILOGY 2 Phase 3 trial of CaPre, and has filed it with the Food and Drug Administration (FDA). As previously disclosed, the Company, along with the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, conducted rigorous post-hoc analysis of TRILOGY 1 data. Analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo), which Acasti refers to as “Pre-randomization Triglyceride (TG) Normalization.” This artefactual phenomenon affected both treatment groups, but was much greater in the placebo group, resulting in the large placebo effect and significant underestimation of the post-randomization treatment effect of the active drug, CaPre. The post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4) corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by the normalization phenomenon, and a meaningful efficacy trend for CaPre was observed.The Company provided all of the TRILOGY 1 background information and accompanying data to the FDA in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to its Type C Meeting request and briefing package, and confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat (ITT) population, as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Based on the FDA’s feedback and input from key experts including Dr. Mozaffarian, Acasti finalized the Statistical Analysis Plan (SAP) for TRILOGY 2 and has now submitted it to the FDA. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020. The key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, are still expected within several weeks following the unblinding of TRILOGY 2 results. Acasti also announced it plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results, as well as to provide an update on the timing for the reporting of the secondary and exploratory endpoints, and the pooled results from both TRILOGY studies. For this reason, the Company does not plan to host its usual quarterly conference call to discuss the financial results for the first fiscal quarter ended June 30, 2020, but expects to report and file its first fiscal quarter 2021 financial results on August 13, 2020.About CaPre (omega-3 phospholipid) Acasti’s prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either “free” or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. In two Phase 2 studies, CaPre achieved a statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients across the dyslipidemia spectrum from patients with mild to moderate hypertriglyceridemia (patients with TG blood levels between 200mg/dl and 500mg/dl) to patients with severe hypertriglyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to actually reduce LDL, or “bad cholesterol”, as well as the potential to increase HDL, or “good cholesterol”, especially at the therapeutic dose of 4 grams/day. The Phase 2 data also showed a significant reduction of HbA1c at a 4-gram dose, suggesting that due to its unique omega-3/phospholipid composition, CaPre may actually improve long-term glucose metabolism. Acasti’s TRILOGY Phase 3 program is currently underway, as noted above.About Acasti Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre, for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. The Company is developing CaPre in a Phase 3 clinical program in patients with severe hypertriglyceridemia, a market that includes 3 to 4 million patients in the U.S. The potential exists to expand the treatable market in the United States to the approximately 50 million people with TGs above 150 mg/dl, given the recent FDA approval of expanded labeling for VASCEPA based on the recent positive REDUCE-IT outcome study results. Acasti may need to conduct at least one additional clinical trial to support FDA approval of a supplemental New Drug Application to expand CaPre’s indications to this segment. Acasti’s strategy is to commercialize CaPre in the U.S. and the Company is pursuing development and distribution partnerships to market CaPre in major countries around the world. For more information, visit www.acastipharma.com.Forward Looking StatementsStatements in this press release that are not statements of historical or current fact constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of U.S. federal securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti’s strategy, future operations, prospects and the plans of management; Acasti’s ability to conduct all required clinical and non-clinical trials for CaPre, including the timing and results of those trials; CaPre’s potential to become the “best-in-class” cardiovascular drug for treating severe Hypertriglyceridemia; the timing and outcome of the unblinding of TRILOGY 2; and Acasti’s ability to file an NDA based on the results of its TRILOGY Phase 3 program. The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the “Special Note Regarding Forward-Looking Statements” section contained in Acasti’s latest annual report on Form 10-K, which will be available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti’s website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti’s public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti’s latest annual report on Form 10-K under the caption “Risk Factors”. Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.Acasti Contact: Jan D’Alvise Chief Executive Officer Tel: 450-686-4555 Email: info@acastipharma.com www.acastipharma.comInvestor Contact: Crescendo Communications, LLC Tel: 212-671-1020 Email: ACST@crescendo-ir.com
- 07/31/2020
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Why Acasti Pharma's Stock Is Trading Higher Today
- Acasti Pharma (NASDAQ: ACST) shares are trading higher on Monday after B.Riley FBR upgraded the stock from Neutral to Buy and announced a price target of $2 per share.Acasti Pharma is a biopharmaceutical innovator advancing a cardiovascular drug, CaPre (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. The company is focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the blood lipids associated with cardiovascular disease risk.The company is developing CaPre in a Phase 3 clinical program in patients with severe hypertriglyceridemiaAcasti Pharma shares were trading up 16.74% at 62 cents on Monday. The stock has a 52-week high of $3.08 and a 52-week low of 25 cents.Latest Ratings for ACST DateFirmActionFromTo Jul 2020B. Riley FBRUpgradesNeutralBuy May 2020Aegis CapitalMaintainsBuy Feb 2020H.C. WainwrightMaintainsBuy View More Analyst Ratings for ACST View the Latest Analyst RatingsSee more from Benzinga * Dominion Energy Analyst Says It's An 'ESG Contender,' Stays Sidelined Following Berkshire Deal * Why Harley-Davidson's Stock Is Trading Higher Today * Why Criteo's Stock Is Trading Higher Today(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- 07/06/2020
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Acasti Pharma Inc. (ACST) CEO Jan D'Alvise on Q4 2020 Results - Earnings Call Transcript
- Acasti Pharma Inc. (NASDAQ:ACST) Q4 2020 Earnings Conference Call June 29, 2020 10:30 AM ET Company Participants Alexandra Botie - Crescendo Communications, LLC
- 06/29/2020
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Acasti Pharma Provides Fiscal 2020 Year-End Business Update
- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today provided a business and TRILOGY Phase 3 Clinical Program update, and announced its operating and financial results for the fiscal year ended March 31, 2020. The Company also reported a phenomenon that it refers to as “Pre-Randomization Triglyceride (TG) Normalization” that occurred between the screening and randomization periods of the study (during qualification), and prior to patients starting on drug or placebo.
- 06/29/2020
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Acasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package
- LAVAL, Québec, June 19, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the FDA has provided Acasti with a written response to its Type C Meeting request and briefing package. The FDA confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat (ITT) population as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Consistent with the Company’s prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission.
- 06/19/2020
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Hedge Funds Souring On Acasti Pharma Inc. (ACST)
- The latest 13F reporting period has come and gone, and Insider Monkey is again at the forefront when it comes to making use of this gold mine of data. Insider Monkey finished processing 821 13F filings submitted by hedge funds and prominent investors. These filings show these funds' portfolio positions as of March 31st, 2020. […]
- 06/05/2020
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28 Stocks Moving in Tuesday's Pre-Market Session
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Aegis Capital Maintains Buy on Acasti Pharma, Lowers Price Target of $2.15
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Does The Acasti Pharma Inc. (CVE:ACST) Share Price Fall With The Market?
- Anyone researching Acasti Pharma Inc. (CVE:ACST) might want to consider the historical volatility of the share price...
- 05/06/2020
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Acasti Pharma Announces Submission Of TRILOGY 1 Briefing Package To FDA
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Acasti Pharma Announces Submission of TRILOGY 1 Briefing Package to FDA
- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it submitted its briefing package on April 29, 2020 to the Food and Drug Administration (FDA) for review. The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020.
- 04/30/2020
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Acasti Pharma Reports Notice Of Allowance For Second Composition Of Matter Patent In Canada
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Acasti Pharma Awarded Notice of Allowance for Second Composition of Matter Patent in Canada
- LAVAL, Québec, April 20, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has received a Notice of Allowance for its second composition matter patent to be awarded by the Canadian Intellectual Property Office. This new patent expands the Company’s existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.
- 04/20/2020
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Acasti Pharma Awarded Notice of Allowance for Second Composition of Matter Patent in Canada
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Oppenheimer Thinks Acasti Pharma's Stock is Going to Recover
- In a report released today, Leland Gershell from Oppenheimer maintained a Buy rating on Acasti Pharma (ACST), with a price target of $7.00. The company's
- 04/02/2020
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Oppenheimer Thinks Acasti Pharma’s Stock is Going to Recover
- In a report released today, Leland Gershell from Oppenheimer maintained a Buy rating on Acasti Pharma (ACST – Research Report),
- 04/02/2020
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10 Biotech Winners And Losers In Q1
- The quarter was brutal to say the least for most asset classes amid the coronavirus (COVID-19) pandemic. The S&P 500 Index was down about 20% for the quarter.
Amid the market...
- 04/01/2020
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Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June
- LAVAL, Québec, April 01, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has filed its meeting request with the Food and Drug Administration (FDA). The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results. The Company will also seek the FDA’s input on Acasti’s proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and agree on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing.
- 04/01/2020
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Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second ...
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Shares of several healthcare companies are trading lower, selling off from this week's strength. While the US stimulus package boosted economic optimism, demand concerns still exist amid the coronavirus outbreak.
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The Daily Biotech Pulse: Mylan Ramps Up Manufacturing Of Potential COVID-19 Drug, Lexicon Stops Study Early, Masimo To Buy German Ventilation Company
- Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs March 19.) * Biomerica, Inc. (NASDAQ: BMRA) * Centogene NV (NASDAQ: CNTG) * Gilead Sciences, Inc. (NASDAQ: GILD) * Imara Inc (NASDAQ: IMRA) * Regeneron Pharmaceuticals
- 03/20/2020
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Stocks That Hit 52-Week Lows On Thursday
- On Thursday morning, 1178 companies hit new 52-week lows.
Facts of Interest:
The largest company by market cap to set a new 52-week low was Nuveen Preferred & Income...
- 03/19/2020
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The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection
- 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 on March 18) * Biomerica, Inc. (NASDAQ: BMRA)( announced commencement of international shipment of rapid COVID-19 test) * BioNTech SE - ADR (NASDAQ: BNTX) *
- 03/19/2020
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The Daily Biotech Pulse: AbbVie, Allergan Agree On Divestments, Obalon Stops Obesity Balloon Sale, COVID-19 Updates
- 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 on March 17) * BioNTech SE - ADR (NASDAQ: BNTX) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) ( Updated on its COVID-19 treatment development plan)Down In The
- 03/18/2020
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The Daily Biotech Pulse: AbbVie, Allergan Agree On Divestments, Obalon Stops Obesity Balloon Sale, COVID-19 Updates
- 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 on March 17) …
- 03/18/2020
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The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment
- Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs March 16.) * BioNTech SE - ADR (NASDAQ: BNTX) (announced efforts to develop a vaccine for COVID-19) * SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)Down In The Dumps
- 03/17/2020
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20 Healthcare Stocks Moving In Monday's Pre-Market Session
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The Daily Biotech Pulse: Roche Obtains FDA Emergency Use Authorization For COVID-19 Test, Chembio Appoints New CEO, Inovio Slumps On Earnings
- Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs March 12.) Masimo Corporation (NASDAQ: MASI ) Down In The Dumps (Biotech stocks that hit 52-week lows March 12.) Abbott Laboratories (NYSE: ABT ) ABIOMED, Inc. (NASDAQ: ABMD ) Acasti Pharma Inc (NASDAQ: ACST ) Accelerate Diagnostics Inc (NASDAQ: AXDX ) AcelRx Pharmaceuticals Inc (NASDAQ: ACRX ) Achieve Life Sciences Inc (NASDAQ: ACHV ) Acorda Therapeutics Inc (NASDAQ: ACOR ) Adamas Pharmaceuticals Inc (NASDAQ: ADMS ) Adamis Pharmaceuticals Corp (NASDAQ: ADM ) Adaptive Biotechnologies Corp (NASDAQ: ADPT ) ADDEX THERAPEUT/ADR (NASDAQ: ADXN ) ADMA Biologics Inc (NASDAQ: ADMA ) Aeglea Bio Therapeutics Inc (NASDAQ: AGLE ) Aerie Pharmaceuticals Inc (NASDAQ: AERI ) AEterna Zentaris Inc. (NASDAQ: AEZS ) Affimed NV (NASDAQ: AFMD ) Aileron Therapeutics Inc (NASDAQ: ALRN ) Aimmune Therapeutics Inc (NASDAQ: AIMT ) Akari Therapeutics PLC (NASDAQ: AKTX ) Akcea Therapeutics Inc (NASDAQ: AKCA ) Akero Therapeutics Inc (NASDAQ: AKRO ) Akers Biosciences Inc (NASDAQ: AKER ) Akorn, Inc.
- 03/13/2020
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Acasti Pharma Awarded Notice of Allowance for Additional Composition of Matter and Method of Use Patents in the United States and Mexico
- LAVAL, Québec, March 11, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has received a Notice of Allowance for an additional composition of matter and method of use patent from the US Patent and Trademark Office (USPTO), the 4th patent to be awarded in the U.S., and a Notice of Allowance for a composition of matter and method of use patent awarded by the Mexican Patent Office, the 3rd patent to be awarded in Mexico.
- 03/11/2020
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Acasti Pharma Awarded Notice Of Allowance For Additional Composition Of Matter And Method Of Use Patents In The United States And Mexico
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The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap 600 Index
- Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs March 9.) Arcutis Biotherapeutics Inc (NASDAQ: ARQT ) Enzo Biochem, Inc. (NYSE: ENZ ) Centogene NV (NASDAQ: CNTG ) Inovio Pharmaceuticals Inc (NASDAQ: INO ) Spherix Inc (NASDAQ: SPEX ) ( added to Friday's advance on clinching an option agreement for coronavirus treatment) Down In The Dumps (Biotech stocks that hit 52-week lows March 9.) ABIOMED, Inc. (NASDAQ: ABMD ) Acasti Pharma Inc (NASDAQ: ACST ) Achieve Life Sciences Inc (NASDAQ: ACHV ) Acorda Therapeutics Inc (NASDAQ: ACOR ) Adamas Pharmaceuticals Inc (NASDAQ: ADMS ) Adaptive Biotechnologies Corp (NASDAQ: ADPT ) ADMA Biologics Inc (NASDAQ: ADMA ) Aeglea Bio Therapeutics Inc (NASDAQ: AGLE ) Aerie Pharmaceuticals Inc (NASDAQ: AERI ) AEterna Zentaris Inc. (NASDAQ: AEZS ) Affimed NV (NASDAQ: AFMD ) Akers Biosciences Inc (NASDAQ: AKER ) Akorn, Inc. (NASDAQ: AKRX ) Aldeyra Therapeutics Inc (NASDAQ: ALDX ) Alexion Pharmaceuticals, Inc.
- 03/10/2020
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Amarin Stock Looks Like a Heart-Healthy Buy on the Dip
- The weak performance of Amarin (NASDAQ:AMRN) has been a head scratcher. Back in December, the company announced a major approval from the U.S. Food and Drug Administration. There was also a strong fourth-quarter report.Source: Pavel Kapysh / Shutterstock.com But Wall Street didn't really care. Since early December, Amarin stock has gone from $24 to $16.Now the recent volatility in the markets has taken a toll, no doubt. And there are some other worries about the company's aggressive spending to build out its infrastructure.InvestorPlace - Stock Market News, Stock Advice & Trading TipsYet despite all this, I think the selloff in Amarin stock has been an overreaction. Why? Well, let's take a deeper look at some of recent developments.First of all, the FDA approval was definitely a game changer. The agency agreed to a new indication and label expansion for the flagship drug, Vascepa. Note that the drug was shown to reduce cardiovascular disease for those with elevated triglyceride levels. This was the conclusion after an extensive clinical trial that lasted seven years. The FDA approval was also unanimous, which is not too common.To put things into perspective, other pharma companies -- like AstraZeneca (NYSE:AZN) and Acasti Pharma (NASDAQ:ACST) -- have been developing their own treatments. But they have proven to be ineffective. As a result, Amarin will be the first to market in this category.In the meantime, the company is aggressively expanding Vascepa in foreign markets. Consider that Amarin received regulatory approval in Canada. There has also been a marketing application in Europe. And then there is China. Amarin's partner in the country should complete the clinical trial by the end of this year.Next, Amarin's growth has been ramping nicely. In the latest quarter, revenues jumped by 85% to $143.3 million, hitting a record for the company. Net income came to $7.1 million, or 2 cents a share, up from a loss of $33.7 million, or 11 cents a share in the same period a year ago.Amarin also reaffirmed its outlook for 2020. The revenues are expected to range from $650 million to $700 million, driven primarily by Vascepa. The RisksAmarin definitely faces some real challenges. Let's face it, building the needed infrastructure will not be cheap -- or easy. * 8 Stocks to Buy in March for a Coronavirus Rebound The company plans to expand the sales force in the U.S. to about 800 reps, representing a doubling on a year-over-year basis. It can be tough to educate and onboard such employees. So, it seems reasonable that there will be some growing pains.Another issue for Amarin stock is that the company must deal with a patent lawsuit from generic drug companies, Dr. Reddy's Laboratories (NYSE:RDY) and Hikma Pharmaceuticals (OTCMKTS:HKMPF). True, it does appear that Amarin has a good case. But then again, litigation can be dicey. Bottom Line on Amarin StockThe market for Amarin is certainly massive. Keep in mind that heart disease is the leading cause of death in the U.S. and costs about $500 billion per year. Vascepa can also be used in conjunction with those taking statins. And note that more than 35 million people in the U.S. take these.In light of all this, it should be no surprise that Vascepa has the potential to be a multibillion-dollar franchise. This should make Amarin very attractive as a buyout candidate for companies like Pfizer (NYSE:PFE) or Merck (NYSE:MRK).Thus, Amarin stock really does look attractive, especially in light of the recent selloff.Tom Taulli (@ttaulli) is the author of various books on investing and technology, including Artificial Intelligence Basics, High-Profit IPO Strategies and All About Short Selling. He is also the founder of WebIPO, which was one of the first platforms for public offerings during the 1990s. As of this writing, he did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 8 Stocks to Buy in March for a Coronavirus Rebound * 5 Big Reasons Stocks Will Rebound From the Coronavirus Selloff * 4 Large-Cap Stocks Still in Trouble The post Amarin Stock Looks Like a Heart-Healthy Buy on the Dip appeared first on InvestorPlace.
- 03/06/2020
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3 Big Stock Charts for Tuesday: Amarin, Campbell Soup, and Church & Dwight
- Tuesday's big stock charts feature three big winners in Monday's big rally — all of which have hopes for further upside ahead.
- 03/03/2020
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Acasti Receives NASDAQ Notification Regarding Minimum Bid Requirements
- LAVAL, Québec, Feb. 28, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that on February 28, 2020, it received written notification from the Nasdaq Listing Qualifications Department (“Nasdaq”) for failing to maintain a minimum bid price of U.S.$1.00 per share for the last 30 consecutive business days, as required by Nasdaq Listing Rule 5550(a)(2) – bid price (the “Minimum Bid Price Rule”). The Nasdaq notification has no immediate effect on the listing of Acasti Pharma’s shares.
- 02/28/2020
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Look Anywhere but Acasti Pharma Stock for Opportunity
- With shares down more than 80%, is there opportunity with Acasti Pharma (NASDAQ:ACST) stock? Don't bet on it! Shares have been hammered since January due to poor Phase 3 results for its prospective hypertriglyceridema treatment CaPre. Like with many biotech stocks, Acasti Pharma stock is a binary play on a single drug's success. Failure for CaPre is bad news for Acasti shares.Source: Pavel Kapysh / Shutterstock.com Considering this factor, there's good reason shares could fall further. Hemorrhaging cash, the company will likely need a dilutive equity infusion to stay in business. This would put further downward pressure on Acasti Pharma stock.Yet, I would not say Acasti Pharma stock has no shot at rebounding. If the company can press on with CaPre, shares could soar if subsequent trials prove successful. However, with Amarin's (NASDAQ:AMRN) competing treatment Vascepa moving ahead, CaPre could easily wind up left in the dust.InvestorPlace - Stock Market News, Stock Advice & Trading Tips * 10 Stocks to Buy for Your 10-Year-Old With long-shot upside and substantial downside risk, there are better opportunities out there. Let's dive in, and see why Acasti Pharma stock is far from being a great biotech play. Grim Future for CaPre Equals Bad News for Acasti Pharma StockWhat went wrong with CaPre? There's ample opportunity for an omega 3-bsaed hypertriglyceridema treatment. Yet so far only Amarin's Vascepa has seen success. Vascepa and CaPre are similar drugs. Except CaPre uses krill oil, while Vascepa uses fish oil. AstraZeneca (NYSE:AZN) also had a similar treatment in the works, but bailed out after poor Phase 3 results of its own.But things may not be so dire for Acasti Pharma stock. CaPre is down, but not out. As InvestorPlace's Ian Bezek discussed Feb. 26, CaPre's TRILOGY 1 Phase 3 results were not statistically significant. In other words, the drug's results were not materially better than that of a placebo. The company is investigating why this occurred, and continues to pursue bringing CaPre to market.CaPre has a second study (TRILOGY 2), for which topline results have yet to be released. With the company auditing TRILOGY 1's results, they don't expect to release the TRILOGY 2 topline results until at least July.In a high risk, high return space, you have to double down. But, for investors in Acasti Pharma stock, are the odds in thier favor? Considering Acasti's cash situation, things don't look so hot. The company has enough cash to survive through the year. However, going forward, Acasti needs an equity infusion.Such a move may keep the lights on, but with an equity raise comes dilution. If Acasti presses on with CaPre, but it doesn't pay off, shares could tumble further down. With Dilution, Shares Could Fall FurtherShares may be below the 50 cent price level, but Acasti Pharma stock could go lower. Why? The dilution factor. Acasti needs more equity capital in order to continue trying to bring CaPre to market. This isn't out of the ordinary for a biotech stock. If this occurs, but CaPre again fails to pay off, shares could continue to decline.With shares under the $1 price level, Acasti Pharma will likely pursue a reverse stock split in order to maintain its NASDAQ listing. They've done this before, back in 2015, but that doesn't prevent shares from falling further. Taking a look at split adjusted prices, Acasti shares have fallen significantly in their history as a public company.If you had invested $10,000 in Acasti Pharma stock back in February 2012, today you would have $388.31 left of your investment. In other words, a 96.12% loss. By comparison, $10,000 invested in the S&P; 500 (NYSEARCA:SPY), would have grown into $28,351 (assuming dividends were reinvested) at the end of January 2020. In other words, a cumulative return of 183.52%.Acasti's past poor performance may not mean bad results in the future. As InvestorPlace's Vince Martin wrote on Jan. 29, Acasti Pharma stock has one last chance. If TRILOGY 2 is a success, and the company can justify the results of TRILOGY 1, it's not "game over" for CaPre. Shares could bounce back significantly as CaPre's approval odds reverse course.This isn't an invitation to buy Acasti Pharma stock. But should be kept in mind for anybody looking to short this name. Shares may have cratered, but with so much bad news priced into the stock, an ounce of positive development could push shares higher. Look at Other Biotech OpportunitiesIt doesn't look good for Acasti Pharma stock. If they plan on doubling-down on CaPre, they need more capital. A dilutive equity raise would push shares down further even if they do a reverse stock split.Yet shares aren't guaranteed to hit zero. If their subsequent actions with CaPre pay off, shares could soar as the prospective drug gets back on track.With this in mind, Acasti Pharma is neither a buy or a sell. If you are looking for speculative biotech names, consider other options.Thomas Niel, contributor to InvestorPlace, has been writing single-stock analysis for web-based publications since 2016. As of this writing, Thomas Niel did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Stocks to Buy for Your 10-Year-Old * 5 Hot Cannabis Stocks to Snap Up * Buy These 5 Super Fast-Growth Dividend Stocks While They Are Down The post Look Anywhere but Acasti Pharma Stock for Opportunity appeared first on InvestorPlace.
- 02/28/2020
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Confounding Decline Creates an Opportunity in Amarin Stock
- Amarin stock has declined by nearly a quarter so far in 2020 on little news. That lower valuation makes AMRN intriguing.
- 02/28/2020
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The Daily Biotech Pulse: Sangamo In Genome-Editing Therapy Deal With Biogen, FDA Nod For Biohaven, Passage Bio IPO
- 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 on Feb. 27)
Global Cord Blood Corp (...
- 02/28/2020
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Acasti Receives NASDAQ Notification Regarding Minimum Bid Requirements
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Stocks That Hit 52-Week Lows On Thursday
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Stocks That Hit 52-Week Lows On Wednesday
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First-Mover Advantage Will Benefit Amarin Stock More Than You Think
- There’s no reason Amarin stock won’t become a big success with Vascepa, especially with access to millions of patients.
- 02/24/2020
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Analysts Are Bullish on These Healthcare Stocks: Atricure (ATRC), Medtronic (MDT)
- There's a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Atricure (ATRC), Medtronic (MDT) and Acasti Pharma (ACST)
- 02/19/2020
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Analysts Are Bullish on These Healthcare Stocks: Atricure (ATRC), Medtronic (MDT)
- There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Atricure (
ATRC
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Research Report
), Medtronic (
MDT
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Research Report
) and Acasti Pharma (
ACST
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Research Report
) with bullish sentiments.
Atricure (AT
- 02/19/2020
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10 Biggest Price Target Changes For Tuesday
- Wells Fargo lowered PVH Corp (NYSE: PVH) price target from $115 to $110. PVH closed at $89.37 on Friday.
Bernstein raised the price target for Tesla Inc (NASDAQ: TSLA) from $...
- 02/18/2020
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H.C. Wainwright Maintains Buy on Acasti Pharma, Lowers Price Target to $3
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Risks Remain, but Amarin Stock Is a Buy at Today’s Prices
- Is there more upside in the cards for Amarin (NASDAQ:AMRN) stock? Shares soared late last year on news of the company's flagship Vascepa treatment receiving an expanded label. But after climbing from around the $15 price level to as high as $26.12/share, interest cooled.Source: Pavel Kapysh / Shutterstock.com When I last wrote about Amarin stock in mid-January, shares traded just under $20/share. Since then, the stock has tread water with shares closing at $18.18 on Feb. 12.One can argue that Vascepa's potential is already priced into shares. But, with similar treatments from competitors facing headwinds, Amarin stock could move higher as analysts anticipate even greater potential sales. On the other hand, nothing's for certain in the biotech game.InvestorPlace - Stock Market News, Stock Advice & Trading Tips * 7 Exciting Stocks to Buy for Aggressive Investors Things could turn on a dime, pushing Amarin shares back down to prior levels. Yet upside may outweigh risks for Amarin stock. Let's dive in and find out why. Amarin Stock Could Move Higher as Competitors FlounderIn my last Amarin stock article, I discussed how Vascepa's upside potential could be thwarted by competition. AstraZeneca's (NYSE:AZN) Epanova and Acasti Pharma's (NASDAQ:ACST) CaPre face headwinds. Both yielded disappointing Phase 3 results. AstraZeneca is now throwing in the towel on Epanova. Acasti is investigating why, as InvestorPlace's Josh Enomoto reported, CaPre was no more effective than a placebo.With these competitors floundering, things look brighter for Vascepa. In other words, there's good reason why Amarin stock could head higher. Yet in the past month, shares haven't budged due to the news. Some investors remain skeptical of Vascepa's prospects. What's driving this negative sentiment? Competitive risk from generics.Two major generic drug-makers, Dr. Reddy's (NYSE:RDY) and Hikma (OTCMKTS:HKMPF) have generics in their pipeline similar to Vascepa. As I wrote in my prior Amarin stock analysis, both generic makers challenged Vascepa's patent. The uncertainty of this litigation is largely what's keeping Amarin shares from heading higher.Jeffries' Michael Yee is confident in Amarin's chances of winning the case. Proceedings in the case have ended, with a written ruling due by March 31. The analyst believes, based on the evidence presented, the court will rule in Amarin's favor. Yee gives shares a "buy" rating with a $30 price target.With these new developments, it seems Vascepa has a clearer shot of becoming a blockbuster drug. However, buying Amarin stock today is no slam-dunk. Multi-billion dollar sales figures are years away. Based on Amarin's guidance, the company should generate between $650 million-$700 million in revenue this year. That's a big jump from 2019's $425 million in sales. But a far cry from Stifel's estimated $3 billion in peak annual sales. What's Amarin Worth to An Acquirer?Annual sales have a long way to go before hitting the estimated peaks. That's not to say Amarin stock isn't worth more than its current trading price. Despite selling for around 9.4 times estimated 2020 sales, I reiterate Amarin remains a takeover target.Amarin stock is no stranger to takeover talk. Major pharma names find it easier to "buy" new drugs instead of spending billions more on R&D.; So far, Amarin has decided to "go it alone." But, I don't see Amarin's board saying no if the price is right.So, what's a fair takeover price for Amarin? Let's assume Vascepa does hit $3 billion in peak sales. Major pharma names like GlaxoSmithKline (NYSE:GSK) and Novartis (NYSE:NVS) have gross margins between 68% and 71%. That implies peak gross profits for Vascepa of around $2 billion.With fixed overhead costs, a major pharma name could add much of this gross profit to the EBITDA line. GSK and NVS have EBITDA margins around 30%, implying fixed costs around 35%-40% of sales. Let's estimate Vascepa's overhead costs are just 30% of sales. That means estimated EBITDA of around $1.14 billion.GSK stock has an EBITDA multiple of 10.3. Novartis has an EBITDA multiple of 15.4. Other names, like Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) have EBITDA multiples around 12. Let's say an acquirer paid $30/share for Amarin stock. Subtracting around $600 million in net cash, that means around a $10.2 billion purchase price for Amarin. In other words, an EBITDA multiple of around nine.Even at a 65% premium to the current Amarin stock price, the company could be an accretive acquisition. Keep in mind this is all back-of-the-envelope. It remains to be seen whether Vascepa lives up to expectations. Bottom Line: Upside Potential Remains, RisksRecent developments could mean more upside for Amarin stock. But keep risks in mind. Amarin next releases quarterly results later this month. If earnings and/or guidance falls short of expectations, shares could move to prior price levels (or lower).Also, the courts could rule against Amarin's favor in the patent suit. Yet, with material upside potential, Amarin stock could be worth the risk.Thomas Niel, contributor to InvestorPlace, has been writing single-stock analysis for web-based publications since 2016. As of this writing, Thomas Niel did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Exciting Stocks to Buy for Aggressive Investors * 20 Stocks to Buy From the Law of Accelerating Returns * 7 U.S. Stocks to Buy on Coronavirus Weakness The post Risks Remain, but Amarin Stock Is a Buy at Today's Prices appeared first on InvestorPlace.
- 02/14/2020
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Acasti Pharma Provides Business Update for the Third Quarter of Fiscal 2020
- LAVAL, Québec, Feb. 14, 2020 -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research,.
- 02/14/2020
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Acasti Pharma Q3 EPS $(0.18) Down From $(0.05) YoY
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Acasti Pharma Schedules Third Quarter Fiscal 2020 and Business Update Conference Call
- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Friday, February 14, 2020 to discuss the Company’s financial results for the third quarter ended December 31, 2019, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre. The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company’s News and Investors section of the website: https://www.acastipharma.com/investors/.
- 02/13/2020
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Acasti Pharma Schedules Third Quarter Fiscal —…—… and Business Update Conference Call
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3 Beaten-Down Biotech Stocks With +50% Upside Potential
- After a stock endures a beating from the public market, it can be tempting to abandon ship. As any seasoned investor knows, if a stock has fallen from grace and is trading at lower levels, there could be a good reason. Whether it be overwhelming recent obstacles or poor underlying fundamentals, all have the potential to hamper a company’s long-term growth prospects and keep them down in the dumps.By the same token, stocks that have been hit hard can present investors with an attractive entry-point before they take off and shoot for the moon. So, how are investors supposed to separate the stocks poised for a recovery from the ones facing insurmountable headwinds? We suggest taking a cue from the pros on Wall Street.Using the Stock Screener tool from TipRanks, we were able to scan the market for compelling yet beaten-down stocks, specifically focusing on those inhabiting the biotech space. The results? 3 biotech names backed by enough Wall Street analysts to earn a “Strong Buy” consensus rating. Adding to the good news, each boasts over 50% upside potential.Zogenix, Inc. (ZGNX)First up is Zogenix, a company focused on developing products that can potentially improve the lives of patients suffering from rare diseases. While data from a Phase 3 study evaluating its Fintepla candidate for Lennox-Gastaut syndrome (LGS), a rare form of epilepsy, had some investors worried, several analysts advocate staying on board.On February 7, ZGNX shares shed 39% of their value following the most recent data readout for Fintepla. The results were actually positive, with the candidate demonstrating a statistically significant reduction in the rate of seizures compared to the placebo, which was the primary endpoint of the study. However, it was the level of difference between the drug and the placebo that left a bad taste in investors’ mouths. A 70% difference in the reduction rate had been achieved when Fintepla was evaluated in Dravet syndrome, another form of epilepsy, but it was only able to produce an 18.7% difference in patients with LGS.Piper Sandler analyst Danielle Brill does acknowledge that the data was underwhelming, but points out that overall, the trial was still positive and should be seen as encouraging. According to the analyst, the data still supports approval, even if the drug will be used less frequently than competing drug, Epidiolex. “With this data, we're almost certain Fintepla use in LGS will be limited to Epidiolex failures. However, it's worth noting again that this was always our base case assumption,” she stated.With Brill expecting Fintepla to be priced at a premium to Epidiolex given its likely last-line therapy status, the five-star analyst sides with the bulls. To this end, she reiterated her Overweight rating as well as the $64 price target, implying a whopping 114% upside potential. (To watch Brill’s track record, click here)All in all, other Wall Street analysts are on the same page. Out of 9 ratings that have been published in the last three months, 8 were bullish, making the Street consensus a Strong Buy. In addition, the $56.75 average price target puts the upside potential at 88%. (See Zogenix stock analysis on TipRanks)Biohaven Pharmaceutical Holding (BHVN)Biohaven boasts a portfolio of innovative products designed to combat neurological and neuropsychiatric diseases.Yesterday, investors got some bad news as the company announced that troriluzole failed to meet its primary endpoint in a Phase 3 clinical trial evaluating its efficacy in treating generalized anxiety disorder (GAD), with shares dipping 8% in response. This prompted the company to discontinue the drug’s development as a monotherapy for the condition. That being said, several members of the Street believe there’s still hope for the company.While calling the data “an unfortunate miss”, Wedbush’s Laura Chico brings up the question of dosing. “We spoke with management who noted the dosing in GAD differs from the other indications with the highest dose (280 mg) being explored in Alzheimer's disease (AD). For our part, we do wonder if that came into play,” she noted.Management is continuing to develop the drug for other indications including obsessive-compulsive disorder (OCD), AD and spinocerebellar ataxia (SCA), a degenerative brain disease that can impact movement. This combined with the lack of tolerability issues related to troriluzole are promising.Chico’s primary focus, though, remains on the upcoming rimegepant migraine prevention data and the acute treatment PDUFA slated for later this month. As the analyst thinks eventual approval is very likely, she remains in favor of this biotech. “With shares pulling back below $50 on the troriluzole anxiety results, we see favorable risk/reward into the upcoming rimegepant catalysts,” she commented.Bearing this in mind, Chico maintained an Outperform rating on the stock. It should also be noted that the analyst’s $75 price target conveys her confidence in BHVN’s ability to surge 59% over the next twelve months. (To watch Chico’s track record, click here)What does the rest of the Street have to say? In general, other analysts are also bullish on the biotech name, 8 out of 9 to be exact. This makes the consensus rating a Strong Buy. Not to mention the $74.13 average price target suggests a 58% twelve-month rise could be in the cards. (See Biohaven stock analysis on TipRanks)Acasti Pharma (ACST)Acasti Pharma’s primary goal is to develop new krill oil-based omega-3 phospholipid therapies that can be used to treat cardiometabolic diseases. CaPre, its lead candidate, was designed as a mixture of polyunsaturated fatty acids (PUFAs) to lower triglycerides while also potentially benefitting LDL-C and HDL-C in patients with severe hypertriglyceridemia. While unexpected trial data contributed to its 77% year-to-date decline, analysts are still betting that ACST can deliver a hefty dose of upside.On February 10, the company released an update noting that a review of Phase 3 TRILOGY 1 results for CaPre in patients with severe hypertriglyceridemia is underway, which includes specific clinical site audits as well as an audit of the central testing laboratory. The original data showed an uncommon placebo response in its topline triglyceride reduction primary endpoint, which was much greater than seen in any previous omega-3 triglyceride reduction trials. Even though management claims to have monitored the trial, several inconsistencies were identified that possibly could have impacted the topline results.Weighing in on ACST for Echelon Wealth Partners is analyst Douglas Loe, who writes, “Though there is no denying that TRILOGY 1 failed to achieve its primary endpoint, independent of any explanations of this that would be irrelevant to statistical analysis of data anyway, we remain optimistic that data audit could reveal secondary details that bear more positively on CaPre’s own triglyceride-lowering activity, activity that has actually been well-documented in prior clinical studies conducted by Acasti itself.”Loe doesn’t dispute the fact that the clinical and regulatory risk remains high, but he does see it as a good sign that it’s making progress in interpreting the unusual data. Additionally, even with TRILOGY 2 data scheduled for release much later than previously expected, the analyst remains optimistic based on his “long-standing positive of CaPre’s published pharmacology and of omega-3 supplementation in general.”In line with this view, Loe reiterated a Buy recommendation. While he set a lower price target of $1.05, the forecast still leaves room for a possible 85% twelve-month gain. (To watch Loe’s track record, click here)As for the rest of the Street, other analysts take a similar approach when it comes to ACST. 3 Buys and 1 Hold issued in the last three months add up to a Strong Buy analyst consensus. The $3.35 average price target suggests that shares could skyrocket 509% in the next twelve months. (See Acasti Pharma price targets and analyst ratings on TipRanks)
- 02/11/2020
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The Daily Biotech Pulse: LogicBio Slapped With Clinical Hold, Agile Inks Debt Deal Ahead of Twirla Approval, Gilead Builds Stake In Sierra Oncology
- 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 on Feb. 10) AbbVie Inc (NYSE: ABBV ) Allergan plc (NYSE: AGN ) )(reacted to better-than-expected results and comments that its deal to be acquired by AbbVie is on track to close by the first quarter) Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY ) Apellis Pharmaceuticals Inc (NASDAQ: APLS ) Aptose Biosciences Inc (NASDAQ: APTO ) Arcutis Biotherapeutics Inc (NASDAQ: ARQT ) Ascendis Pharma A/S (NASDAQ: ASND ) AtriCure Inc. (NASDAQ: ATRC ) ChemoCentryx Inc (NASDAQ: CCXI ) Co-Diagnostics Inc (NASDAQ: CODX )(announced sales of its new coronavirus test ) Cue Biopharma Inc (NASDAQ: CUE ) Deciphera Pharmaceuticals Inc (NASDAQ: DCPH ) DexCom, Inc. (NASDAQ: DXCM ) Esperion Therapeutics Inc (NASDAQ: ESPR ) Fulgent Genetics Inc (NASDAQ: FLGT ) GALAPAGOS NV/S ADR (NASDAQ: GLPG ) Insulet Corporation (NASDAQ: PODD ) Kodiak Sciences Inc (NASDAQ: KOD )(reacted to positive data readout from early-stage study of experimental drug to treat eye disorders) Masimo Corporation (NASDAQ: MASI ) Novartis AG (NYSE: NVS ) Pacira Biosciences Inc (NASDAQ: PCRX ) Principia Biopharma Inc (NASDAQ: PRNB ) PTC Therapeutics, Inc (NASDAQ: PTCT ) Revance Therapeutics Inc (NASDAQ: RVNC ) ResMed Inc.
- 02/11/2020
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80 Biggest Movers From Yesterday
- Gainers
Taubman Centers, Inc. (NYSE: TCO) shares jumped 53.2% to close at $53.12 on Monday. Simon Property Group, Inc. (NYSE: SPG) said Monday it plans to purchase an 80%...
- 02/11/2020
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Acasti Pharma Provides Update on TRILOGY 1 and TRILOGY 2 Phase 3 Trials of CaPre
- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, or HTG (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that a detailed examination of the Phase 3 TRILOGY 1 results for CaPre is underway, including specific clinical site audits and an audit of the central testing laboratory. As previously reported, the Company noted a highly unusual placebo response in its topline triglyceride reduction primary endpoint, far greater than seen in any prior omega-3 triglyceride lowering trials, with 5 sites out of the total 54 enrolling sites disproportionately contributing to this placebo response.
- 02/10/2020
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Mid-Afternoon Market Update: Dow Rises 70 Points; vTv Therapeutics Shares Jump
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6 Biotechnology Stocks Moving In Wednesday's Pre-Market Session
- Gainers
• Moleculin Biotech, Inc. (NASDAQ:MBRX) stock rose 35.2% to $1.19 during Wednesday's pre-market session.
• Arbutus Biopharma, Inc. (NASDAQ:ABUS) shares rose...
- 02/05/2020
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8 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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Shares of several healthcare companies are trading higher in sympathy with the overall market on a rebound after increased fear of the Wuhan coronavirus' impact on the economy dropped the Dow roughly 600 points on Friday.
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Stock Market Hits Record Highs; JPMorgan, Target, Boeing, UnitedHealth, Morgan Stanley In Focus: Weekly Review
- The Dow Jones and stock market rally powered to new highs. JPMorgan, UnitedHealth and Morgan Stanley earnings beat, but Target warned. Boeing woes continue.
- 01/17/2020
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Does Acasti Stock Have a Future?
- Acasti Pharma (NASDAQ:ACST) is a classic example of the extreme volatility of small-cap biotech stocks. It was only in late December that the shares were fetching $2.87, up from $1 a year earlier. But now ACST stock is trading around 79 cents, with a market cap of about $70 million. To provide some context, in 2013 the shares were trading around $40.Source: Shutterstock Founded in 2002, Acasti specializes in developing prescription drugs that use omega-3 fatty acids derived from krill oil. Keep in mind that those acids have been shown to effectively reduce triglycerides, thereby helping to make people's hearts healthier.The problem is that the underlying science is extremely complex and challenging. That was certainly highlighted recently when Acasti received disappointing results from a Phase 3 clinical trial of its CaPre drug. The drug was supposed to treat patients who suffer from severe hypertriglyceridemia, in which triglyceride blood levels range from 500 mg/dL to 1500 mg/dL.InvestorPlace - Stock Market News, Stock Advice & Trading TipsAs for the trial, it did have some positive outcomes. For example, the drug produced a 30.5% median reduction in triglyceride levels over a 12-week term. The median triglyceride reduction of patients taking the drug in combination with a statin was 42.2%, versus a 31.5% median reduction for those taking a placebo and a statin.So what went wrong? According to Acasti's press release: "Both the placebo and CaPre study groups experienced significant reductions in triglycerides within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, TRILOGY 1 did not reach statistical significance." * The Top 5 Dow Jones Stocks to Buy for 2020 Despite this setback, Acasti is not giving up. The company is analyzing the data to determine the reasons for the endpoint miss. The remaining top-line data from the trial will be released in the next couple of weeks, and the FDA is expected to issue more analysis about the secondary endpoints of the trial within the next couple months. Additional positive data could emerge, boosting ACST stock.But I think investors should be extremely cautious about ACST. Just look at AstraZeneca (NYSE:AZN), whose fish-derived heart drug Epanova also failed to meet its primary endpoint in a clinical trial. In fact, the company decided to stop developing the drug, resulting in a $100 million writeoff. The Bottom Line on ACST StockACST is all about CaPre. So if the drug is not progressing sufficiently, the company's prospects will certainly be ominous.It's also important to point out that Acasti's rival, Amarin (NASDAQ:AMRN), is continuing to make headway with its fish-oil drug, Vascepa. During the latest reported quarter, Vascepa's sales soared 103% year-over-year to $112.4 million. That will definitely make things tougher on ACST.Also, consider that Amarin recently received FDA approval for an expanded indication for Vascepa. The drug was shown to be effective for patients who have elevated triglyceride levels of ≥150 mg/dL. According to Dr. Deepak Bhatt, an executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, the treatment "represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins…"Vascepa's annual sales could reach $4 billion within the next three or four years. In other words, for investors looking for a play on the cardiovascular market, Amarin looks like a pretty good option, while ACST stock looks like a name that they should avoid.Tom Taulli is the author of the book, Artificial Intelligence Basics: A Non-Technical Introduction. Follow him on Twitter at @ttaulli. As of this writing, he did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * The Top 5 Dow Jones Stocks to Buy for 2020 * 7 Fintech ETFs to Buy Now for Fabulous Financial Exposure * 3 Tech Stocks to Play Ahead of Earnings The post Does Acasti Stock Have a Future? appeared first on InvestorPlace.
- 01/17/2020
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Why Amarin Stock Is Poised for a Healthy 2020
- Amarin (NASDAQ:AMRN) stock has been choppy for the past year, as the price has made multiple attempts to move above the $23-$24 range. However, this has been a stubborn line of resistance, considering the stock price is currently around $20.Source: Pavel Kapysh / Shutterstock.com Despite this, Amarin stock has still been a pretty good bet over the years. After all, the five-year average return is close to 80%.So, what now? Could there be an opportunity with Amarin stock? Well, I think so.InvestorPlace - Stock Market News, Stock Advice & Trading TipsTo see why, let's get a brief backgrounder on the company. Founded in 1993, Amarin is one of the leaders in leveraging lipid science and polyunsaturated fatty acids to create pharmaceuticals to improve heart health. The main drug is Vascepa, which has posted robust growth. In the latest quarter, revenues hit $112.4 million, up 103% on a year-over-year basis. This has been due to substantial increases in the number of subscribers and higher levels of prescriptions per prescriber. * 10 Cheap Stocks to Buy Under $10 However, the key for Amarin is that it recently gained FDA approval for wider applications for Vascepa. This decision, ironically enough, came on Friday the 13th last month -- but of course, this really should be a very lucky day. Vascepa's DevelopmentThe new indication and label expansion -- which is the result of a decade of research and development -- is for a therapy to reduce "the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease."Yes, this is kind of medical jargon. But when boiling things down, the new use for Vascepa is a game changer.According to Dr. Deepak Bhatt, an executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, the treatment "represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins…"The market opportunity is enormous, as there -- on average -- one cardiovascular death occurring every 40 seconds in the U.S. Also, the financial costs of cardiovascular disease events are burdensome at about $500 billion a year -- the most costly in the U.S. The CompetitionThere are a myriad of companies trying to do what Amarin has done; that is, using lipid therapies for cardiovascular disease. But, the science has proven quite complex and challenging.Note that there have been some recent examples of Phase 3 trials that shown disappointing results, such as from AstraZeneca (NYSE:AZN) and Acasti Pharma (NASDAQ:ACST). In fact, since December, ACST has plunged from $2.87 to around $0.80 per share.In fact, Cantor Fitzgerald analyst Louise Chen recently wrote after these companies' failures that "AMRN has been the only company in its class with an outcomes study (REDUCE-IT) that has shown a statistically significant benefit in reducing [cardiovascular] disease. We think the news today underscores our view that AMRN is an interesting asset in a consolidating space." Bottom Line On Amarin StockLast week, Amarin issued revised guidance for 2019. Revenues are now expected to range from $410 million to $425 million, which is at or slightly above the upper end of the prior forecast. The company also noted that beyond 2020, Vascepa's total net revenue "will grow to reach multiple billions of dollars" because "the history of other therapies for chronic conditions suggests that growth builds over multiple years."Given this, the growth story should be robust for quite some time. This should also stir up mergers & acquisitions interest from the mega pharma companies like Pfizer (NYSE:PFE), Merck (NYSE:MRK) and even AZN.Let's face it, they need to fill their pipelines with blockbuster drugs -- and these companies certainly have the resources to pay a premium price for Amarin.Tom Taulli is the author of the book, Artificial Intelligence Basics: A Non-Technical Introduction. Follow him on Twitter at @ttaulli. As of this writing, he did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Cheap Stocks to Buy Under $10 * 5 Retail Stocks Placer.ai Thinks Can Win Big in 2020 * 6 Cheap Stocks to Buy Under $7 The post Why Amarin Stock Is Poised for a Healthy 2020 appeared first on InvestorPlace.
- 01/17/2020
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34 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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AstraZeneca to End Phase III Study on Fish Oil Heart Drug
- AstraZeneca (AZN) to discontinue STRENGTH study on its fish-oil pill Epanova in mixed dyslipidaemia on recommendation of an independent Data Monitoring Committee
- 01/14/2020
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The Daily Biotech Pulse: PhaseBio To Buy Hypertension Asset, Stemline Falls On Q4 Pre-Announcement, FDA Panel To Review Nektar's Opioid Drug
- The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks that hit 52-week highs on Jan. 13.)
Arvinas Inc (...
- 01/14/2020
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13 Healthcare Stocks Moving In Tuesday's Pre-Market Session
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Mid-Afternoon Market Update: Acasti Pharma Falls On Failed Late-Stage Trial; Verona Pharma Shares Gain
- Toward the end of trading Monday, the Dow traded up 0.17% to 28872.00 while the NASDAQ rose 0.88% to 9,259.66. The S&P also rose, gaining 0.56% to 3,283.62.
Leading and...
- 01/13/2020
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Mid-Day Market Update: Crude Oil Down Over 1%; Dare Bioscience Shares Spike Higher
- Midway through trading Monday, the Dow traded up 0.20% to 28881.58 while the NASDAQ rose 0.49% to 9223.50. The S&P also rose, gaining 0.38% to 3277.76.
Leading and Lagging...
- 01/13/2020
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Mid-Morning Market Update: Markets Open Higher; Cott To Acquire Primo Water
- Following the market opening Monday, the Dow traded up 0.07% to 28,844.56 while the NASDAQ rose 0.38% to 9,213.47. The S&P also rose, gaining 0.26% to 3,273.88.
Leading and...
- 01/13/2020
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Acasti Pharma downgraded to Neutral from Buy at B. Riley FBR ACST
- Acasti Pharma downgraded to Neutral from Buy at B. Riley FBR B. Riley FBR ACST
- 01/13/2020
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Acasti Shares Slump On Failed Late-Stage Trial, Amarin Moves In Sympathy
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50 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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31 Healthcare Stocks Moving In Friday's Pre-Market Session
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Acasti Pharma shares are trading higher on a rebound after the stock price dropped on December 23rd after releasing news surrounding its TRILOGY 1 trial.
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Acasti Delays Data Readout For Drug To Treat Elevated Triglycerides
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Acasti Expects to Report Trilogy 1 Topline Results in January 2020 With Topline Results for Trilogy 2 Still Expected by End of January 2020; Says Implementation of Trilogy 2 Study Remains on Track
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28 Healthcare Stocks Moving In Friday's Pre-Market Session
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30 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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Acasti Pharma shares are trading higher on seemingly no company-specific news. The stock is trading on higher-than-average volume. NOTE: Penny stocks can have volatile price action with no catalyst.
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24 Stocks Moving in Monday's Pre-Market Session
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Acasti Pharma shares are trading higher. Not seeming any company-specific news to justify the price action.
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Acasti Pharma Reports Last Patient Visit In TRILOGY 1 Phase 3 Trial Of CaPre For Treatment Of Severe Hypertriglyceridemia, Says On Track To Support Topline Results For TRILOGY 1 In Dec., TRILOGY 2 In Jan. 2020
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63 Biggest Movers From Yesterday
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38 Stocks Moving In Wednesday's Mid-Day Session
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Amarin slips 3% on bearish coverage
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B. Riley FBR Reinstates Buy on Acasti Pharma, Announces $8 Price Target
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30 Healthcare Stocks Moving In Friday's Pre-Market Session
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19 Healthcare Stocks Moving In Thursday's Pre-Market Session
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Acasti Pharma Q2 EPS $(0.34) Misses $(0.16) Estimate
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Acasti Pharma shares are trading higher despite no company-specific news. The stock is trading on higher-than-average volume.
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Acasti Pharma Reports Partnership With Aker BioMarine To Deliver Krill Oil To Co. Under 2-Year Deal, No Terms Disclosed
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28 Healthcare Stocks Moving In Friday's Pre-Market Session
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Acasti Pharma And Amarin In Severe Hypertriglyceridemia
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Acasti Pharma (ACST) Investor Presentation - Slideshow
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25 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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Acasti Pharma Announces Phase 3 Milestones Achieved
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23 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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Acasti Pharma (ACST) Investor Presentation - Slideshow
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Acasti Pharma Receives Funding From The Government Of Canada To Expand Production Capacity
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UPDATE: B. Riley FBR On Acasti Pharma Also Notes 'CaPre could be the best-in-class omega-3 fatty acid drug and could capture a large share of the market, even without a first-to-market advantage. We project >C$100M in sales revenue in FY24'
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Acasti Pharma Announces the Election of Its Directors, Amendments to Its Stock Option and ...
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22 Healthcare Stocks Moving In Tuesday's Pre-Market Session
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33 Healthcare Stocks Moving In Monday's Pre-Market Session
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75 Biggest Movers From Yesterday
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32 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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Shares of several healthcare companies are trading lower in sympathy with the overall market amid growing concerns over the U.S.-China trade war. This morning, President Trump announced the U.S. will not be doing business with Huawei.
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50 Healthcare Stocks Moving In Thursday's After-Market Session
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70 Biggest Movers From Yesterday
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40 Healthcare Stocks Moving In Thursday's After-Market Session
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88 Biggest Movers From Yesterday
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71 Stocks Moving In Wednesday's Mid-Day Session
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45 Healthcare Stocks Moving In Monday's After-Market Session
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