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Has BioDelivery Sciences International (BDSI) Outpaced Other Medical Stocks This Year?

  • Here is how BioDelivery Sciences International (BDSI) and Vertex Pharmaceuticals (VRTX) have performed compared to their sector so far this year.
    03/18/2022

Earnings Preview: BioDelivery Sciences International (BDSI) Q4 Earnings Expected to Decline

  • BioDelivery (BDSI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
    03/02/2022
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BioDelivery Sciences International, Inc. (BDSI) can buy. Click on Rating Page for detail.

The price of BioDelivery Sciences International, Inc. (BDSI) is 5.59 and it was updated on 2024-11-12 07:01:37.

Currently BioDelivery Sciences International, Inc. (BDSI) is in undervalued.

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BioDelivery Sciences International (BDSI) Just Flashed Golden Cross Signal: Do You Buy?

  • Good things could be on the horizon when a stock experiences a golden cross event. How should investors react?
    Thu, Feb. 24, 2022

BioDelivery (BDSI) Stock Surges on Buyout Offer From Collegium

  • Collegium (COLL) is set to acquire BioDelivery (BDSI) for approximately $604 million in cash. The transaction is likely to be completed by the end of first-quarter 2022.
    Tue, Feb. 15, 2022

BDSI Stock Alert: The Deal Sending Little-Known BioDelivery Skyrocketing Today

  • Today, a big takeover announcement has sent shares of BioDelivery and BDSI stock soaring more than 50% on investor enthusiasm for this deal. The post BDSI Stock Alert: The Deal Sending Little-Known BioDelivery Skyrocketing Today appeared first on InvestorPlace.
    Mon, Feb. 14, 2022

3 Potential Value Opportunities to Consider

  • When seeking value opportunities, investors could be interested in the following stocks, since their prices are trading at a discount to the intrinsic value calculated by GuruFocus' earnings-based discounted cash flow (DCF) calculator.
    Mon, Feb. 14, 2022

Trading Penny Stocks? Top Stock Market News for February 14th, 2022

  • Check these penny stocks out for your watchlist today The post Trading Penny Stocks? Top Stock Market News for February 14th, 2022 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
    Mon, Feb. 14, 2022
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BioDelivery's stock rockets toward a 2-year high after buyout deal with Collegium at a 54% premium

  • Shares of BioDelivery Sciences International Inc. BDSI, -1.62% blasted 51.7% higher to pace all premarket gainers Monday, after the specialty pharmaceutical company with a portfolio of pain and neurology products agreed to be acquired by Collegium Pharmaceutical Inc. COLL, -0.23% in a deal valued at about $604 million. Collegium's stock was still inactive ahead of the open.
  • 02/14/2022

Why the Earnings Surprise Streak Could Continue for BioDelivery (BDSI)

  • BioDelivery (BDSI) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.
  • 02/07/2022

Why Shares of BioDelivery Sciences International Jumped 12.2% on Monday

  • Shares of the small pharmaceutical company, which focuses on pain management, have been rising since it released updated guidance late last week.
  • 01/24/2022

Best Penny Stocks to Buy During The Down Market? 3 to Watch

  • Here are three penny stocks to watch with the stock market down today The post Best Penny Stocks to Buy During The Down Market? 3 to Watch appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 01/24/2022

These 3 Penny Stocks Exploded Today, Here's Why

  • Here are three penny stocks you should add to your watchlist The post These 3 Penny Stocks Exploded Today, Here's Why appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 01/21/2022

BioDelivery (BDSI) Stock Up on Raised Guidance for 2021

  • BioDelivery Sciences International (BDSI) raises its financial guidance for full-year 2021. BDSI expects sales at the high end of its previous guidance.
  • 01/21/2022

BioDelivery Sciences Stock (BDSI): Why The Price Surged Today

  • The stock price of BioDelivery Sciences International, Inc. (NASDAQ: BDSI) increased by 26.92% today. This is why it happened.
  • 12/20/2021

Why BioDelivery Sciences International Stock Was Up 28.5% Monday

  • The biotech company received a favorable court ruling regarding its lead therapy.
  • 12/20/2021

Making a List of Penny Stocks to Buy? Check These 3 Out Right Now

  • Check these penny stocks out for your watchlist right now The post Making a List of Penny Stocks to Buy? Check These 3 Out Right Now appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 12/20/2021

Hot Penny Stocks To Buy For Under $5 Right Now

  • Making a list of the best penny stocks to buy now? These 4 have turned heads in the stock market today.
  • 12/20/2021

Why Is BioDelivery (BDSI) Down 20.8% Since Last Earnings Report?

  • BioDelivery (BDSI) reported earnings 30 days ago. What's next for the stock?
  • 12/03/2021

Best Reddit Penny Stocks to Buy Now? 4 to Watch in Mid-November

  • Are these Reddit penny stocks on your watchlist right now? The post Best Reddit Penny Stocks to Buy Now?
  • 11/10/2021

BioDelivery Sciences International's (BDSI) CEO Jeff Bailey on Q3 2021 Results -Earnings Call Transcript

  • BioDelivery Sciences International's (BDSI) CEO Jeff Bailey on Q3 2021 Results -Earnings Call Transcript
  • 11/03/2021

BioDelivery Sciences International (BDSI) Tops Q3 Earnings Estimates

  • BioDelivery (BDSI) delivered earnings and revenue surprises of 16.67% and -2.28%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?
  • 11/03/2021

BioDelivery Sciences International (BDSI) is a Top-Ranked Momentum Stock: Should You Buy?

  • The Zacks Style Scores offers investors a way to easily find top-rated stocks based on their investing style. Here's why you should take advantage.
  • 09/21/2021

4 Penny Stocks To Buy According To Analysts & Price Targets Up To 507%

  • Biotech Penny Stocks Surge As Sector Reverses Course The post 4 Penny Stocks To Buy According To Analysts & Price Targets Up To 507% appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 09/14/2021

Best Reddit Penny Stocks To Buy Now? 5 For Your List In September 2021

  • Which Reddit penny stocks are on your watchlist right now? The post Best Reddit Penny Stocks To Buy Now?
  • 09/12/2021

BioDelivery Sciences: Legal Fees Are Causing My Pain

  • BioDelivery Sciences: Legal Fees Are Causing My Pain
  • 09/09/2021

BioDelivery Sciences to Exhibit Three Scientific Posters Comparing BELBUCA® to Oxycodone at the PAINWeek 2021 Conference

  • RALEIGH, N.C., Sept. 07, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, will showcase three scientific posters regarding BELBUCA® (buprenorphine buccal film), CIII at the PAINWeek 2021 Conference taking place September 7 – 11, 2021 at The Cosmopolitan of Las Vegas.
  • 09/07/2021

BioDelivery Sciences to Participate in Upcoming Virtual Investor Conferences

  • RALEIGH, N.C., Sept. 03, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey Bailey, Chief Executive Officer, and Terry Coelho, Executive Vice President and Chief Financial Officer, will present and participate in one-on-one investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference taking place on September 13-15 and the Cantor Fitzgerald Global Healthcare Conference taking place on September 27-30.
  • 09/03/2021

BioDelivery Sciences: Yet Another Buying Opportunity

  • BDSI trades at extremely low P/E and EV/S ratios for a company that is still growing at a good clip.
  • 08/27/2021

Top Penny Stocks You Need to Know About Right Now

  • Are these top penny stocks on your small-caps watchlist The post Top Penny Stocks You Need to Know About Right Now appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 08/20/2021

BioDelivery Sciences International (BDSI) is a Top-Ranked Momentum Stock: Should You Buy?

  • Whether you're a value, growth, or momentum investor, finding strong stocks becomes easier with the Zacks Style Scores, a top feature of the Zacks Premium research service.
  • 08/10/2021

BioDelivery Sciences International, Inc.'s (BDSI) CEO Jeff Bailey on Q2 2021 Results - Earnings Call Transcript

  • BioDelivery Sciences International, Inc.'s (BDSI) CEO Jeff Bailey on Q2 2021 Results - Earnings Call Transcript
  • 08/04/2021

BioDelivery Sciences Reports Mixed Q2 Earnings, Sees FY21 Belbuca Sales At Lower End Of Guidance Range

  • BioDelivery Sciences International Inc (NASDAQ: BDSI) has reported Q2 sales of $41.4 million, + 13.3% Y/Y, missing the consensus of $42.4 million.  Sales growth was driven by all-time high Belbuca sales of $36.5 million, +13% Y/Y, and Symproic sales of $4 million, up 18% Y/Y.
  • 08/04/2021

BioDelivery Sciences Announces Agreement to Acquire U.S. and Canadian Rights to FDA-approved ELYXYB™ for the Acute Treatment of Migraine

  • The only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults
  • 08/04/2021

This Undervalued Biotech Penny Stock Could Soon Double

  • A handful of trends might drive BioDelivery Sciences' share price growth.
  • 07/13/2021

Best Reddit Penny Stocks to Buy Now? 7 for Your July Small-Caps List

  • Are these Reddit penny stocks the best 7 to watch in July 2021? The post Best Reddit Penny Stocks to Buy Now?
  • 07/07/2021

BioDelivery Sciences: Clinic-To-Market Transition Problem

  • BDSI has been doing very well with product sales. However, it has never seen the peak it saw during approvals of lead drugs.
  • 05/28/2021

BioDelivery Sciences International, Inc. (BDSI) CEO Jeffrey Bailey on Q1 2021 Results - Earnings Call Transcript

  • BioDelivery Sciences International, Inc. (BDSI) CEO Jeffrey Bailey on Q1 2021 Results - Earnings Call Transcript
  • 05/06/2021

BioDelivery Sciences International (BDSI) Misses Q1 Earnings Estimates

  • BioDelivery (BDSI) delivered earnings and revenue surprises of -28.57% and 0.07%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?
  • 05/06/2021

BioDelivery Sciences International (BDSI) Earnings Expected to Grow: Should You Buy?

  • BioDelivery (BDSI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
  • 04/29/2021

5 Health Care Stocks Trading with Low Price-Earnings Ratios

  • As of April 21, the GuruFocus All-in-One Screener, a Premium feature, found that the following guru-owned utilities have low price-earnings ratios. While some of them are great value investments, others may need to be researched more carefully, according to the discounted cash flow calculator.
  • 04/21/2021

BioDelivery Sciences to Report First Quarter 2021 Financial Results on May 6, 2021

  • RALEIGH, N.C., April 20, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that it will report its first quarter 2021 financial results before the open of the U.S. financial markets on Thursday, May 6, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.
  • 04/20/2021

3 Magic Formula Health Care Stock Picks

  • If you want to enhance your likelihood to beat the market, one method is to select stocks that rank highly according to the "Magic Formula" criteria.
  • 04/19/2021

BioDelivery (BDSI) Down 12.8% Since Last Earnings Report: Can It Rebound?

  • BioDelivery (BDSI) reported earnings 30 days ago. What's next for the stock?
  • 04/09/2021

Moving Average Crossover Alert: BioDelivery Sciences (BDSI)

  • BioDelivery Sciences (BDSI) could be a stock to avoid from a technical perspective, as the firm is seeing unfavorable trends on the moving average crossover front
  • 03/30/2021

BioDelivery Sciences International, Inc. (BDSI) CEO Jeff Bailey on Q4 2020 Results - Earnings Call Transcript

  • BioDelivery Sciences International, Inc. (BDSI) CEO Jeff Bailey on Q4 2020 Results - Earnings Call Transcript
  • 03/10/2021

Recap: BioDelivery Sciences Q4 Earnings

  • Shares of BioDelivery Sciences Intl (NASDAQ:BDSI) rose 6.1% in pre-market trading after the company reported Q4 results. Quarterly Results Earnings per share rose 66.67% year over year to $0.10, which beat the estimate of $0.06.
  • 03/10/2021

Earnings Preview: BioDelivery Sciences International (BDSI) Q4 Earnings Expected to Decline

  • BioDelivery (BDSI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
  • 03/03/2021

BioDelivery Sciences to Present Three Scientific Posters Comparing BELBUCA® to Oxycodone at the 2021 North American Neuromodulation Society (NANS) Meeting

  • Oral Presentation of Data from Phase I Safety Study & Secondary Respiratory OutcomesComparing BELBUCA® to Oxycodone on January 16 from 1:10pm – 2:10pm CT
  • 01/15/2021

BioDelivery Sciences to Participate in the Piper Sandler 32nd Annual Healthcare Conference

  • RALEIGH, N.C., Nov. 20, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeff Bailey, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in a fireside chat and 1x1 investor meetings at the Piper Sandler 32nd Annual Healthcare Conference.
  • 11/20/2020

BioDelivery Sciences to Present Virtually and Host 1x1 Investor Meetings at the Annual Southwest IDEAS Investor Conference on November 18

  • RALEIGH, N.C., Nov. 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey Bailey, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in the virtual Southwest IDEAS Investor Conference on November 18, 2020. BDSI's presentation will be webcasted and is scheduled to be available at 7:00 am CST on November 18. The presentation can be accessed through the Southwest IDEAS conference portal for registered participants, in the investor relations section of the Company's website: www.bdsi.com, and on the IDEAS conference website: www.IDEASconferences.com.
  • 11/11/2020

BioDelivery Sciences International, Inc. (BDSI) CEO Jeff Bailey on Q3 2020 Results - Earnings Call Transcript

  • BioDelivery Sciences International, Inc. (BDSI) CEO Jeff Bailey on Q3 2020 Results - Earnings Call Transcript
  • 11/05/2020

BioDelivery Sciences Reports Strong Q3 2020 Results

  • Total Company Net Revenue Increased 30% versus Prior Year Reaching a Record $39.4 Million
  • 11/05/2020

BioDelivery Sciences Announces $25 Million Share Repurchase Program

  • RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that its Board of Directors has authorized the repurchase of up to $25 million of the Company's shares of common stock.
  • 11/04/2020

BioDelivery Sciences Announces Appointment of Jeff Bailey as Permanent CEO

  • RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that its Board of Directors has appointed Jeff Bailey as permanent Chief Executive Officer (CEO), effective November 4, 2020. Jeff had previously been appointed as interim CEO in May 2020 while continuing to serve on the Board of Directors.
  • 11/04/2020

My Pound The Table Moment For BioDelivery Sciences

  • BDSI share price continues to drop for no good reasons that I can see. Growth remains robust, with much more expected in the future and cash finally coming in after the years of building to this point.
  • 09/04/2020

BioDelivery Sciences International (NASDAQ:BDSI) Shareholders Have Enjoyed A 53% Share Price Gain

  • By buying an index fund, you can roughly match the market return with ease. But many of us dare to dream of bigger...
  • 08/10/2020

BioDelivery (BDSI) Q2 Earnings Miss, Revenues Beat, Stock Up

  • BioDelivery's (BDSI) strong Belubca sales drive the top line. Symproic further boosts revenues. Stock up.
  • 08/06/2020

BioDelivery Sciences International (BDSI) Q2 Earnings Lag Estimates

  • BioDelivery (BDSI) delivered earnings and revenue surprises of -75.00% and 0.87%, respectively, for the quarter ended June 2020. Do the numbers hold clues to what lies ahead for the stock?
  • 08/05/2020

BioDelivery Sciences Reports Strong Q2 2020 Results

  • Second Quarter Total Company Net Revenue Increased 23% versus Prior Year to $36.6 Million Second Quarter BELBUCA® Net Sales Increased 34% versus Prior Year to $32.3 MillionBELBUCA and Symproic® Each Reach All Time High TRx Volume and Market Share Conference Call and Webcast Scheduled for 8:30 AM EST TodayRALEIGH, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the second quarter ended June 30, 2020, as well as the following operational and performance highlights.Key Business Highlights * Total Company net revenue for the second quarter increased by 23% versus the prior year period to $36.6 million. This growth was driven by BELBUCA net sales of $32.3 million, an increase of 34% versus the prior year period, and Symproic net sales of $3.4 million, an increase of 7% compared to the second quarter of 2019. * Total BELBUCA prescriptions reached an all-time high of 104,687 during the second quarter, representing year-over-year prescription volume growth of 31%. * Total Symproic prescriptions were more than 17,200 in the second quarter, representing growth of 11% versus the prior year. * Appointed Jeffrey A. Bailey as interim Chief Executive Officer (CEO). * Successfully adapted commercial model in response to evolving COVID-19 market conditions, which included a reduction in patient visits to physicians.  This was demonstrated by robust brand performance year over year, while also tightly managing expenses to drive positive net income.“Our business has proven to be extremely resilient during the second quarter as seen with the all-time high TRx volume and market shares achieved for both BELBUCA and Symproic,” stated Jeff Bailey, interim CEO of BDSI. “BDSI is in the best financial position it has ever been from a cash and profitability perspective, and fundamentally the demand for BELBUCA and Symproic is strong, positioning the company well to continue supporting our commercial team with new and enhanced tools adapted for the current environment.”Second Quarter 2020 Financial ResultsTotal Company Net Revenue for the second quarter of 2020 was $36.6 million, an increase of 23% compared to $29.7 million in the second quarter of 2019, and a decrease of 4% compared to $38.3 million in the first quarter of 2020.BELBUCA Net Sales for the second quarter of 2020 were $32.3 million, an increase of 34% compared to $24.1 million in the second quarter of 2019, and a decrease of 3% compared to $33.5 million in the first quarter of 2020.Symproic Net Sales for the second quarter were $3.4 million, an increase of 7% compared to $3.2 million in the second quarter of 2019, and a decrease of 18% compared to $4.2 million in the first quarter of 2020.BUNAVAIL Net Sales for the second quarter were $0.7 million, compared to $0.8 million in the second quarter of 2019. In March of this year, the Company announced the planned discontinuation of marketing of BUNAVAIL and ceased shipping product on June 15, 2020.Total Operating Expenses for the second quarter of 2020 were $28.2 million, compared to $26.7 million in the first quarter of 2020 and $22.0 million in the second quarter of 2019. Second quarter costs declined $3.6 million compared to the first quarter of 2020, excluding the $5.1 million of non-recurring costs related to the CEO transition.GAAP Net Income for the second quarter of 2020 was $1.2 million, or $0.01 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, for the first quarter of 2020 and GAAP net loss of $11.1 million, or ($0.13) per share, in the second quarter of 2019.EBITDA for the second quarter of 2020 was $5.1 million, or 14% of net sales, compared to $7.8 million in the first quarter of 2020 and $4.8 million in the second quarter of 2019.Non-GAAP Net Income for the second quarter of 2020 was $9.6 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, non-recurring financial impact of the BUNAVAIL discontinuation and the non-recurring financial impact of the CEO transition.Cash Position: As of June 30, 2020, cash and cash equivalents were approximately $91.0 million, compared to $63.9 million at December 31, 2019, reflecting the generation of $5.0 million of positive operating cash flow and $2.5 million in proceeds from the exercise of options, together with $19.6 million of net proceeds from increasing our existing credit facility.“A very important objective through this COVID-19 pandemic has been to ensure the health and safety of our employees and the communities we serve,” stated Jeff Bailey. “Lastly, I’d like to thank the entire BDSI team for their commitment and continued focus on meeting patient needs.”Conference Call & Webcast DetailsBioDelivery Sciences will host a conference call and webcast today, August 5, 2020, at 8:30 a.m. ET to present second quarter 2020 results and to provide a business update.  Dial-in details are as follows:Date: Wednesday, August 5, 2020 Time:8:30 AM Eastern Time Domestic:866-248-8441 International:720-452-9102 Conference ID:9339657 Webcast:http://public.viavid.com/index.php?id=141000 ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation.CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTSThis press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA and Symproic net sales and total company net revenue in 2020 may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.Non-GAAP Financial MeasuresThis press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs in second quarter 2019, and the financial impact of certain one-time items that are non-recurring, including the financial impact of the debt refinancing in second quarter 2019, the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition.EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes, depreciation and amortization.The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
  • 08/05/2020

With Biotech Stocks, Investors Love the Thrill of the Chase

  • Individual investors are placing their bets on biotech companies pursuing coronavirus advances. Some invest for fun and profit, while others want to be a part of a historic breakthrough.
  • 08/05/2020

The Daily Biotech Pulse: Novavax Vaccine Data, Aerpio Gets $5.1M Funding For COVID Trial, Rigel Gains Big On Earnings

  • Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 4) ABIOMED, Inc. (NASDAQ: ABMD) (FDA approved the emergency use of Abiomed's Impella heart pump in combination...
  • 08/05/2020

Texas medical board warns physicians who claim COVID-19 cure

  • The Texas board that licenses doctors has warned physicians that it could take action against anyone who falsely advertises a cure for COVID-19
  • 08/04/2020

Coronavirus update: U.S. case tally at 4.72 million and New Jersey, Massachusetts and Connecticut see infections climb again

  • The U.S. case tally for the coronavirus illness COVID-19 rose by fewer than 50,000 on Monday for a second straight day, data aggregated by Johns Hopkins...
  • 08/04/2020

U.S. government begins two trials testing Eli Lilly's coronavirus antibody drug

  • The trials, called ACTIV-2 and ACTIV-3, will look at U.S. drugmaker Eli Lilly's experimental treatment known as LY-CoV555, which is being developed in partnership with Canadian biotech AbCellera.
  • 08/04/2020

Abiomed's stock rises on second COVID-19-related EUA for heart pump

  • Shares of Abiomed Inc. undefined rallied 2.0% in premarket trading on Tuesday after the company said its Impella heart pump had received an emergency use...
  • 08/04/2020

Easterly Government Properties Reports Second Quarter 2020 Results

  • Easterly Government Properties, Inc. (NYSE: DEA) (the “Company” or “Easterly”), a fully integrated real estate investment trust (“REIT”) focused prima
  • 08/04/2020

GW Pharma's stock rallies after its cannabinoid drug gets a new FDA approval

  • Shares of GW Pharmaceuticals undefined rallied 5.0% in trading on Monday after the drugmaker said its cannabinoid drug Epidiolex had received approval from...
  • 08/03/2020

We Could Know if Moderna’s Covid-19 Vaccine Works by Halloween, Analyst Says

  • Jefferies analyst estimates the biotech’s Phase 3 trial has a 65% chance of working.
  • 08/03/2020

WSJ News Exclusive | FDA’s Shifting Standards for Chinese Face Masks Fuel Confusion

  • A Food and Drug Administration effort to address a mask shortage has opened the floodgates to Chinese manufacturers selling products of widely varying quality, potentially putting the public at risk and leaving some U.S. states with stockpiles they no longer trust.
  • 08/03/2020

TikTok, SpaceX and the Allure of Private Companies

  • Microsoft confirms TikTok talks, coronavirus is now widespread in both urban and rural areas, Biden VP pick pushed back, and other news to start your day.
  • 08/03/2020

AP FACT CHECK: Trump hype on drug costs, hydroxychloroquine

  • President Donald Trump is making grandiose claims about slashing drug prices and the efficacy of a treatment for COVID-19 that don't hold up to reality
  • 08/03/2020

Celltrion riceve l'approvazione della MHRA per l'avvio nel Regno Unito della sperimentazione di Fase I su CT-P59, un trattamento potenziale a base di anticorpi antivirali contro il COVID-19

  • Celltrion Group ha annunciato che l'Agenzia di regolamentazione dei medicinali e dei prodotti sanitari (MHRA) del Regno Unito ha approvato la domanda
  • 08/03/2020

Nation's testing czar: It's 'time to move on' from talk about hydroxychloroquine

  • Brett Giroir says emphasis should be on "effective" ways to curb the virus despite Trump's continued promotion of hydroxychloroquine.
  • 08/02/2020

The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings

  • Biotech stocks came under pressure in the week ended July 31 amid mixed earnings from the sector and some adverse clinical readouts. COVID-19 news flow continued to pour in,...
  • 08/02/2020

Health officials link US salmonella outbreak to red onions

  • Federal officials say an outbreak of salmonella infecting nearly 400 people in more than 30 states has been linked to red onions and identified a California company as the likely source
  • 08/01/2020

Health officials link US salmonella outbreak to red onions

  • Federal officials say an outbreak of salmonella infecting nearly 400 people in more than 30 states has been linked to red onions and identified a California company as the likely source
  • 08/01/2020

Guest lineups for the Sunday news shows

  • Guest lineups for the Sunday news shows
  • 07/31/2020

Fauci confident virus vaccine will get to Americans in 2021

  • Dr. Anthony Fauci says he is confident that a coronavirus vaccine will be ready by early next year
  • 07/31/2020

White House denies report that national coronavirus testing plan was scrapped to hurt blue states

  • The White House denied a report claiming the Trump administration scrapped plans for a national coronavirus testing strategy to make Democratic governors in some hard-hit states look bad as "entirely false."
  • 07/31/2020

A Vaccine Will Only Succeed if Americans Have Trust

  • Right now, too many don't. The former head of immunization at the CDC explains why vaccine hesitancy has become a serious problem.
  • 07/31/2020

The Three Key Hurdles for a Coronavirus Vaccine to Clear

  • Making a safe, effective Covid-19 vaccine will be hard enough, but distributing it and building trust for widespread participation will be even harder.
  • 07/31/2020

Don’t fall for that video. Hydroxychloroquine is not a COVID-19 cure. - Poynter

  • The Food and Drug Administration has not approved hydroxychloroquine for the prevention or treatment of COVID-19. Research has been inconclusive.
  • 07/31/2020

Gilead swings to a big loss on acquisition expense, stock falls after earnings and revenue miss

  • Shares of Gilead Sciences Inc. fell more than 1% in after-hours trading Thursday after the drugmaker reported that it swung to a large loss during the second...
  • 07/31/2020

Republicans and Democrats Find a Point of Agreement: Big Tech Is Too Powerful

  • If the partisans of America’s elected leadership seem to agree on almost nothing these days, Wednesday’s Big Tech antitrust hearing was stark evidence that they do share one common target.
  • 07/30/2020

U.S. hits 4.5 million coronavirus cases, Vietnam posts record rise in infections

  • The coronavirus has infected more than 17.3 million people around the world as of Friday, killing at least 673,527 people.
  • 07/30/2020

Quest says FDA cleared new 'lab method' that will cut coronavirus testing delays

  • "Covid-19 with the flu season is going to be more problematic than where we're at today," LabCorp CEO Adam Schechter said Tuesday.
  • 07/29/2020

Earnings Preview: BioDelivery Sciences International (BDSI) Q2 Earnings Expected to Decline

  • BioDelivery (BDSI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
  • 07/29/2020

Kodak’s stock triples as company announces pandemic plan to start making pharmaceutical ingredients

  • The Trump administration’s $765 million loan to the Eastman Kodak Co. to launch a business making pharmaceutical ingredients sent shares of the once iconic...
  • 07/29/2020

Coronavirus live updates: Global infections top 17 million; Australia reports new daily record cases

  • The coronavirus has infected more than 17 million people around the world as of Thursday, killing at least 667,060 people.
  • 07/29/2020

Trump says he still thinks hydroxychloroquine works in treating early stage coronavirus

  • Trump acknowledged support for the drug has become political, largely because he's backed it in the past.
  • 07/28/2020

Twitter, Facebook and YouTube are taking down that hydroxychloroquine video, and now Donald Trump Jr. can’t tweet for 12 hours

  • One doctor shown in the video has said alien DNA is being used in medical treatments
  • 07/28/2020

Kodak lands loan to bolster US-produced drug supply

  • Photography company Eastman Kodak is set to receive a $765 million government loan to create a new division that will help make ingredients for use in generic drugs
  • 07/28/2020

Dr. Fauci on Trump criticism: 'I have not been misleading the American public under any circumstances'

  • The comment came in response to retweets from President Trump accusing Fauci of misleading Americans. The posts have since been removed.
  • 07/28/2020

Stocks making the biggest moves in the premarket: McDonald's, 3M, Pfizer, Harley-Davidson & more

  • The stocks making the biggest moves in premarket trading include McDonald's, 3M, Pfizer, Harley-Davidson, and more.
  • 07/28/2020

BioDelivery Sciences to Report Second Quarter 2020 Financial Results on August 5, 2020

  • RALEIGH, N.C., July 27, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that it will report its second quarter 2020 financial results before the open of the U.S. financial markets on Wednesday, August 5, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. Conference Call Dial-In & Webcast Information:Date: Wednesday, August 5, 2020 Time:8:30 AM Eastern Time Domestic:866-248-8441 International:720-452-9102 Conference ID:9339657 Webcast:http://public.viavid.com/index.php?id=141000 About BioDelivery Sciences International, Inc. BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation.© 2020 BioDelivery Sciences International, Inc. All rights reserved.Contact: Bob Yedid LifeSci Advisors 646-597-6989 Bob@LifeSciAdvisors.com
  • 07/27/2020

Opinion | Trump’s Drug Price Panic

  • He adopts Biden-like controls that would harm U.S. innovation.
  • 07/26/2020

Opinion | Covid Shows the Need for a Diagnostic Stockpile

  • Congress can meet the current surge in demand for testing and be ready for the next pandemic.
  • 07/26/2020

Wells Fargo & Company MN Boosts Stock Position in BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

  • Wells Fargo & Company MN lifted its position in BioDelivery Sciences International, Inc. (NASDAQ:BDSI) by 73.3% during the 1st quarter, according to its most recent filing with the Securities and Exchange Commission. The firm owned 300,305 shares of the specialty pharmaceutical company’s stock after buying an additional 127,021 shares during the quarter. Wells Fargo & […]
  • 07/16/2020

BioDelivery Sciences: Fundamentals Continue Divergence From Share Price

  • Shares of BDSI have plummeted since my buy recommendation on January 3rd. Revenues and earnings continue to rise and exceed expectations.
  • 07/16/2020

Trump administration changes its process for collecting and reporting U.S. coronavirus hospital data

  • "Whatever they can do to fix the data in the interim is great. Long-term, it needs to be improved in general," Dr. Bill Winkenwerder, former assistant Secretary of Defense for health affairs, said.
  • 07/15/2020

BD to sell 750,000 coronavirus tests to U.S. government

  • Becton Dickinson and Co. undefined said Wednesday that the U.S. government plans to buy 750,000 of the company's COVID-19 antigen diagnostic tests. The...
  • 07/15/2020

Johnson & Johnson Reports Earnings Tomorrow. Here’s What to Expect.

  • The company will have a chance to lay out its plans for weathering the pandemic and economic crisis through the second half of the year.
  • 07/15/2020

ChemWerth Files its 500th Drug Master File with FDA

  • ChemWerth Inc., a leading full-service supplier of generic Active Pharmaceutical Ingredients (APIs), files its 500th Drug Master File with the FDA.
  • 07/15/2020

Moderna Says It Plans to Start Phase 3 Trial of Covid-19 Vaccine on July 27

  • Amid reports of delays, the biotech company aims to meet its target of beginning the trial in July.
  • 07/14/2020

Coronavirus update: Global cases of COVID-19 climb above 13 million as California, Hong Kong and India reimpose restrictions on movement

  • The number of confirmed cases of the coronavirus illness COVID-19 climbed above 13 million on Tuesday, and the world’s eighth biggest economy, California,...
  • 07/14/2020

Rigel's stock jumps 25% after announcing U.K. trial for possible COVID-19 treatment

  • Shares of Rigel Pharmaceuticals Inc. undefined gained 25% in premarket trading on Tuesday after announcing that a drug used to treat an autoimmune disorder...
  • 07/14/2020

3M partners with MIT researchers to develop U.S.-backed rapid coronavirus antigen test

  • The device, which is in the early stages of development, would function much like a pregnancy test, said Cathy Tarnowski, senior technical manager at 3M.
  • 07/14/2020

Cashing in on coronavirus: Small biopharma company NanoViricides sees stock soar on treatment claims

  • As the coronavirus was spreading in China, a small biopharma company, NanoViricides, claimed it was close to clinical trials for a treatment. A CNBC investigation found the 15-year-old company has never tested a product in humans or made any revenue.
  • 07/14/2020

La FDA a accepté l’IND de Celyad Oncology pour CYAD-211, un premier candidat CAR-T allogénique basé sur la technologie shRNA ne faisant pas appel à l’édition du génome

  • Regulatory News: Celyad Oncology SA (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD) (Euronext & Nasdaq: CYAD), une société de biotechnologie au stade c
  • 07/14/2020

Cramer's earnings watch: 'If the banks get hammered, things could get ugly'

  • "This is the week when we find out if the real world is going to intrude on the stock market world," the "Mad Money" host said.
  • 07/13/2020

Stocks making the biggest moves after hours: Tesla, BioNTech, Moderna and more

  • See which stocks are posting big moves after the bell.
  • 07/13/2020

Nasdaq tumbles 2.1% to mark biggest intraday reversal in 3 months as California orders rollback on eased coronavirus restrictions

  • U.S. stock indexes squandered a powerful, technology-led rally Monday, with gains collapsing as California signaled that it was re-imposing some restrictions...
  • 07/13/2020

ElectroCore's stock rockets in active trading after EUA issued for its gammaCore Saphire CV

  • Shares of electroCore Inc. undefined more than doubled (up 155%) on very heavy volume in afternoon trading Monday, after the bioelectronic medicine company...
  • 07/13/2020

Coronavirus update: Global case tally edges toward 13 million, and Florida trounces one-day case record set by California last week

  • The number of confirmed cases of the coronavirus illness COVID-19 worldwide edged closer to 13 million on Monday, a day after the World Health Organization...
  • 07/13/2020

Moderna Stock Jumps as Analyst Expects the FDA to Approve Its Covid-19 Vaccine

  • Jefferies analyst Michael Yee says the FDA could issue the vaccine an emergency use authorization by early next year.
  • 07/13/2020

U.S. students get sicker from the coronavirus than kids in other countries, are at 'higher risk,' Dr. Scott Gottlieb says

  • "We have more co-morbid illness among young people in this country, more asthma, more obesity, more diabetes, so there is going to be higher risk with our school age population," former FDA chief Dr. Scott Gottlieb said.
  • 07/13/2020

CytoDyn's stock falls after hitting roadblock in FDA application for investigational HIV drug

  • Shares of CytoDyn Inc. undefined fell 9.4% in trading on Monday after the company said it received a refusal to file letter from the Food and Drug...
  • 07/13/2020

Pfizer, BioNTech Are Surging Because the FDA Fast Tracked Their Covid-19 Vaccines

  • The FDA’s Fast Track designation speeds review and approval of experimental drugs that could fill unmet medical needs. Pfizer and BioNTech had announced promising data on one of the four Covid-19 vaccines they are developing, and the Fast Track designation covers another, as well.
  • 07/13/2020

Nasdaq hits record high Monday's open as stock market buoyed by coronavirus vaccine hope

  • U.S. stocks jumped at the start of trading Monday after the Food and Drug Administration granted "fast track" status to two coronavirus vaccine candidates....
  • 07/13/2020

Enzo Biochem shares rise on FDA authorization for coronavirus test

  • Shares of Enzo Biochem Inc. undefined rallied 7.7% in premarket trading on Monday after the company said it received an emergency use authorization from the...
  • 07/13/2020

What to watch today: Dow to open higher as Wall Street cheers positive vaccine news

  • Wall Street is set to open higher as potential coronavirus vaccines from Pfizer and BioNTech get 'fast track' approval from the FDA.
  • 07/13/2020

5 things to know before the stock market opens Monday

  • Dow futures rally even as U.S. coronavirus cases continue to spike. PepsiCo kicks off the earnings season.
  • 07/13/2020

Stocks making the biggest moves in the premarket: PepsiCo, Analog Devices, Carnival, Pfizer & more

  • The stocks making the biggest moves in premarket trading include PepsiCo, Analog Devices, Carnival, Pfizer, and more.
  • 07/13/2020

Lannett to cut jobs following FDA approval of competing generic drug

  • Shares of Lannett Company Inc. undefined gained 0.2% after the company said it will cut 80 positions, about 8.5% of its total workforce, over concerns that...
  • 07/13/2020

Pfizer, BioNTech stocks surge after COVID-19 vaccine candidates get Fast Track designation

  • Share of Pfizer Inc. undefined rallied 2.3% and of BioNTech SE undefined jumped 5.3% in premarket trading Monday, after the companies said two of their...
  • 07/13/2020

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Expected to Post Quarterly Sales of $36.55 Million

  • Equities analysts expect BioDelivery Sciences International, Inc. (NASDAQ:BDSI) to announce sales of $36.55 million for the current fiscal quarter, according to Zacks. Six analysts have made estimates for BioDelivery Sciences International’s earnings, with the lowest sales estimate coming in at $33.30 million and the highest estimate coming in at $39.52 million. BioDelivery Sciences International reported […]
  • 07/13/2020

Pfizer, BioNTech Jump After Fast-Track Designation; Moderna a Buy

  • Pfizer, BioNTech Jump After Fast-Track Designation; Moderna a Buy
  • 07/13/2020

Did Hedge Funds Make The Right Call On BioDelivery Sciences International, Inc. (BDSI) ?

  • At the end of February we announced the arrival of the first US recession since 2009 and we predicted that the market will decline by at least 20% in (see why hell is coming). In these volatile markets we scrutinize hedge fund filings to get a reading on which direction each stock might be going. […]
  • 07/12/2020

14,733 Shares in BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Purchased by Canandaigua National Corp

  • Canandaigua National Corp bought a new position in BioDelivery Sciences International, Inc. (NASDAQ:BDSI) during the second quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The fund bought 14,733 shares of the specialty pharmaceutical company’s stock, valued at approximately $64,000. Several other large investors have also recently bought and sold […]
  • 07/12/2020

Deutsche Bank AG Sells 1,069,793 Shares of BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

  • Deutsche Bank AG lowered its position in BioDelivery Sciences International, Inc. (NASDAQ:BDSI) by 97.3% during the 1st quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 30,167 shares of the specialty pharmaceutical company’s stock after selling 1,069,793 shares during the quarter. Deutsche Bank AG’s […]
  • 07/12/2020

Philip Morris says cigarette sales in many places could end in a decade and they’ve got a ‘safer’ product to replace them

  • Philip Morris is encouraging stakeholders to work with them to move smokers to cigarette alternatives at a time with cigarette consumption is declining.
  • 07/11/2020

BioNTech’s CEO Strikes Sober Note Amid Vaccine Scramble, While Warning It Could Take a Decade to Beat Covid-19

  • The more cautious remarks from Ugur Sahin reflect what appears to be the executive’s generally sober outlook on the Covid-19 pandemic.
  • 07/10/2020

Gilead Says New Analysis Suggests Remdesivir Reduces Covid-19 Deaths

  • Gilead cautioned that the finding—a 62% reduction in Covid-19 deaths—needed to be confirmed in clinical trials.
  • 07/10/2020

Dr. Scott Gottlieb estimates as many as 1 in 150 people in U.S. are infected with coronavirus

  • "The prevalence of actual infection in the country right now must be pretty high," the former FDA commissioner told CNBC on Friday.
  • 07/10/2020

A new Gilead analysis indicates remdesivir can reduce death but company says finding 'requires confirmation'

  • Shares of Gilead Sciences Inc. undefined gained 2.0% in premarket trading on Friday after the drugmaker disclosed findings from a new analysis of previously...
  • 07/10/2020

Gilead says remdesivir coronavirus treatment reduces risk of death in severely sick patients

  • The findings show that 7.6% of patients treated with remdesivir died compared with 12.5% of patients in the analysis who did not receive remdesivir treatment.
  • 07/10/2020

Coronavirus live updates: Record single-day spike in cases; Gottlieb says 1 in 150 Americans are infected

  • The coronavirus has infected more than 12.29 million people around the world as of Friday, killing at least 555,486 people.
  • 07/10/2020

Travel Industry Earnings Preview: Preparing For A Big Drop

  • For much of the first half of this year, consumers stuck at home as the coronavirus circled the globe. Many people only dreamed of taking off to faraway lands or cruising across...
  • 07/10/2020

Coronavirus update: Global cases of COVID-19 top 12 million, and WHO warns pandemic is ‘not under control’

  • The number of confirmed cases of the illness caused by the coronavirus rose above 12 million on Thursday, as the World Health Organization warned that the...
  • 07/09/2020

Siemens Mobility: Michael Peter will be sole CEO

  • Siemens AG said late Wednesday that Siemens Mobility co-chief executive Sabrina Soussan will exit the business, leaving Michael Peter as sole chief executive...
  • 07/09/2020

The Supreme Court gave abortion-rights supporters a win, but those on both sides of the debate say the battle is far from over

  • Those opposed to abortion see other victories ahead in their work to reduce access to the service.
  • 07/08/2020

Gilead Begins a Trial of an Inhaled Version of Its Covid-19 Drug for Less-Sick Patients

  • A randomized, placebo-controlled trial of an inhaled version of its Covid-19 antiviral remdesivir is testing the drug’s safety and tolerability.
  • 07/08/2020

'Desperation science' slows the hunt for coronavirus drugs

  • Six months after COVID-19 started spreading around the globe, desperation rather than information is still driving many decisions about how to treat the disease
  • 07/08/2020

Gilead's stock drops as it starts early-stage trial for inhaled remdesivir

  • Shares of Gilead Sciences Inc. undefined fell 1.4% in trading on Wednesday after the drugmaker said it started a Phase 1a clinical study testing an inhaled...
  • 07/08/2020

Biogen Stock Is Jumping. The Biotech Submitted Its Troubled Alzheimer’s Drug for FDA Approval.

  • Biogen has finished submitting its application for approval for aducanumab to the Food and Drug Administration. That submission was originally expected to be completed in early 2020.
  • 07/08/2020

Biogen's stock rises on submission to FDA for Alzheimer's drug application

  • Shares of Biogen undefined jumped 7.4% in premarket trading on Wednesday after the drugmaker and Eisai Co. Ltd. [: j:4523] said they completed the submission...
  • 07/08/2020

Stocks making the biggest moves premarket: Nikola, Apple, Biogen, Intersect ENT & more

  • Intersect ENT is reportedly mulling a takeover offer from Medtronic. Nikola gets an upgrade from JPMorgan.
  • 07/08/2020

Merck, Eisai to put experimental cancer combination in new clinical trial

  • Shares of Merck & Co. Inc. undefined gained 0.1% in premarket trading on Wednesday after it received a complete response letter from the Food and Drug...
  • 07/08/2020

Biotechs in the Thick of the Covid-19 Vaccine Race. Can They Get to the Finish Line?

  • As drugmakers prepare to submit their vaccines for Food and Drug Administration approval, are the smaller biotechs up to the task?
  • 07/08/2020

Coronavirus Test-Kit Maker Dissolves Amid Probes

  • A company awarded a no-bid $10.2 million federal contract to make Covid-19 test kits notified state regulators it closed its doors amid U.S. investigations, congressional inquiries and complaints from former workers.
  • 07/07/2020

Coronavirus update: U.S. COVID-19 cases climb above 2.9 million; ‘We’re still knee-deep in the first wave,’ Dr. Fauci warns

  • The number of U.S. cases of the coronavirus illness COVID-19 climbed above 2.9 million on Tuesday, as Dr. Anthony Fauci warned Americans the country is...
  • 07/07/2020

Philip Morris gets FDA approval to market its 'tobacco heating system' as a healthier alternative to smoking

  • The Food and Drug Administration (FDA) announced Tuesday that it has authorized Philip Morris International Inc. undefined to market its IQOS tobacco heating...
  • 07/07/2020

Cruise companies hire Dr. Scott Gottlieb, other coronavirus experts to help overcome 'rough patch'

  • The cruise industry faces a challenging task: convincing customers and regulators that it's safe to go on a cruise again.
  • 07/07/2020

The U.S. Is Buying $450M of Regeneron’s Experimental Covid-19 Antibody. Its Stock Is Jumping.

  • The company said the first doses could be ready as early as the end of the summer.
  • 07/07/2020

FDA alerts health care providers about false positives for one of BD's COVID-19 tests

  • Shares of Becton Dickinson & Co. undefined were down 0.7% in premarket trading on Tuesday, the day after the Food and Drug Administration issued an alert...
  • 07/07/2020

There’s No Stopping Tesla Stock

  • Why American coronavirus deaths aren’t rising, who received PPP loans, MLB teams cancel practice, and other news to start your day.
  • 07/07/2020

Regeneron's stock gains on $450 million manufacturing deal with U.S. for experimental COVID-19 treatment

  • Shares of Regeneron Pharmaceuticals Inc. undefined gained 0.9% in premarket trading on Tuesday after the drugmaker said it received $450 million from the...
  • 07/07/2020

Rapid ASPECTS is First Ever Neuroimaging Solution to Receive CADx Clearance from the FDA

  • AI-powered stroke imaging solution from RapidAI first to receive FDA advanced CADx clearance to raise reading capabilities for non-expert readers
  • 07/07/2020

Trump official defends misleading claim 99% of coronavirus cases are 'harmless'

  • Mark Meadows, White House chief of staff, spoke out as US death toll topped 130,000 following surge of new Covid-19 cases
  • 07/06/2020

U.S. coronavirus response still crippled by lack of testing, Dr. Scott Gottlieb says

  • "It's a bigger problem than we thought it would be at this point," former FDA chief Dr. Scott Gottlieb said Monday.
  • 07/06/2020

Shares of Immunomedics jump on positive confirmatory data for its breast-cancer drug

  • Shares of Immunomedics Inc. undefined gained 6.9% in trading on Monday after the drugmaker said a confirmatory Phase 3 clinical trial of its breast-cancer...
  • 07/06/2020

Stock Market Expectations For Second Half Of 2020

  • The month of June is now officially over, and there have been exceptional quarterly returns (Q2 2020) for major U.S.
  • 07/06/2020

WHO formally drops hydroxychloroquine, HIV drug from COVID-19 drug study

  • The World Health Organization (WHO) on Saturday said that it discontinued studies evaluating hydroxychloroquine and AbbVie's undefined HIV drug Kaletra as...
  • 07/06/2020

Stocks making the biggest moves in the premarket: Becton Dickinson, Regeneron, Uber, Netflix & more

  • The stocks making the biggest moves in premarket trading include Becton Dickinson, Regeneron, Uber, Netflix, and more.
  • 07/06/2020

BD's stock gains on launch of rapid COVID-19 diagnostic test

  • Shares of Becton Dickinson & Co. undefined gained 3.6% in premarket trading on Monday after the diagnostics company announced the launch of a point-of-care...
  • 07/06/2020

ADC Therapeutics meldet Aufhebung der teilweisen Unterbrechung der zulassungsrelevanten klinischen Phase-2-Studie mit Camidanlumab-Tesirin durch die US-Zulassungsbehörde FDA

  • ADC Therapeutics SA (NYSE:ADCT), ein in der klinischen Forschung tätiges Biotechnologieunternehmen mit Schwerpunkt auf Onkologie und Vorreiter in der
  • 07/06/2020

Coronavirus testing a stress threat for athletic budgets

  • Colleges might have to pay into the hundreds of thousands of dollars to have their football players and other athletes tested for coronavirus
  • 07/05/2020

Trump celebrates Fourth of July by stoking division over pandemic and race

  • Republican support shows signs of cracks as president says protesters over racial injustice ‘trample our freedoms’
  • 07/05/2020

Goldman Sachs Predicts That GDP Will Shrink Even More Than Anticipated

  • A slower recovery than expected will hurt 2020 GDP growth, the bank says.
  • 07/05/2020

Riassunto: ViiV Healthcare annuncia di avere ricevuto dalla FDA l’approvazione all’uso di Rukobia (fostemsavir), un trattamento innovativo dell’HIV in adulti che hanno a disposizione poche opzioni di trattamento

  • ViiV Healthcare, la multinazionale specializzata nei trattamenti dell’HIV e la cui quota di maggioranza è detenuta da GSK, con Pfizer Inc. e Shionogi
  • 07/03/2020

The Number of Covid-19 Cases Is Rising. What Comes Next.

  • Governments face a major challenge as cases surge: whether or not to lock down. Meanwhile, the market hangs on news of a number of vaccine makers preparing to launch larger clinical trials. The next weeks or months are critical to controlling the pandemic.
  • 07/02/2020

Moderna Stock Tumbles on Report of Covid-19 Vaccine Trial Delay

  • The health-care news website Stat reported the biotech company was delaying the start of a Phase 3 trial of its experimental Covid-19 vaccine.
  • 07/02/2020

Just one coronavirus vaccine isn’t enough, Fauci says - The Boston Globe

  • The world needs more than one vaccine to tackle the new coronavirus, even as pharma companies race to be the first with a pandemic shot, the infectious-disease expert says.
  • 07/02/2020

Health officials: Quick work for COVID-19 vaccine a 'risk we have to take'

  • Top U.S. health officials told lawmakers Thursday they're pursuing multiple technologies to develop a COVID-19 vaccine that could cut months off the normal time it takes to get it to market.
  • 07/02/2020

Why MEI Pharma Is Tanking 15.3% Today | The Motley Fool

  • A trial evaluating its most advanced drug has been discontinued because of a lack of efficacy.
  • 07/02/2020

Coronavirus update: U.S. sees biggest one-day spike in cases of COVID-19 as health experts urge caution for July 4 holiday

  • The U.S. recorded the highest number of new cases of the coronavirus illness COVID-19 in a single day at more than 50,000 on Wednesday, according to data...
  • 07/02/2020

US gobbles up nearly all of Gilead Covid-19 drug remdesivir for next 3 months, leaving other nations without

  • HHS said it had acquired all the supplies of the drug for July and 90% of supplies for August and September. Many developing countries have access to generic versions, but WTO rules could complicate the ability of wealthy nations to import them.
  • 07/02/2020

Metric Capital Seeking Turkish Investments After Drugmaker Deal - BNN Bloomberg

  • Metric Capital Partners LLP is looking for more deals in Turkey after investing more in the country’s manufacturing industry than any other international private-equity company over the past two years.
  • 07/02/2020

Fauci: New wave of COVID-19 'way beyond worst spikes we've seen'

  • Dr. Anthony Fauci, the United States' top-ranking infectious diseases expert, said Thursday there's a risk of an even larger spread of COVID-19 unless a recent wave of new cases are brought under control.
  • 07/02/2020

Cornell president: In-person fall classes will be safer for our students than all virtual semester

  • Cornell plans to spend $3 million to $5 million to "mandate testing, and tracing and isolation, on a very aggressive regular basis," University President Martha Pollack told CNBC.
  • 07/02/2020

Sandoz loses challenge to patent on Amgen’s $5.2B autoimmune drug, may appeal to Supreme Court

  • A federal appeals court upheld two key patents covering Amgen's Enbrel, thus further preventing Novartis' generics unit from launching its biosimilar. However, an analyst wrote that the probability of Sandoz overturning the decision is low.
  • 07/02/2020

Dr. Scott Gottlieb says he thinks the worst of the U.S. coronavirus epidemic 'will be over by January'

  • "This will be over by January one way or the other," former FDA Commissioner Dr. Scott Gottlieb said on "Squawk Box."
  • 07/02/2020

Hahn: Americans might have to wait until next year for COVID vaccine

  • The U.S. may not see a coronavirus vaccine until next year, FDA Commissioner Stephen Hahn said as an increasing number of Americans say they would get the shot.
  • 07/02/2020

Pfizer Stock as Company Unveils Aggressive Timeline for Coronavirus Vaccine

  • Analysts said it is far from a sure thing that Pfizer and its partner, BioNTech, will be able to win FDA approval as quickly as they indicated they might.
  • 07/02/2020

Return of March panic is the biggest risk to the S&P 500 right now. Here’s the trigger

  • Our call of the day has charted out some highs and lows for the S&P 500 that investors need to watch out for in coming weeks and months. And here’s what...
  • 07/02/2020

Markets May Have a Reason to Rise Along With Covid-19 Cases - BNN Bloomberg

  • As the weeks go by, the timeline for a coronavirus vaccine is getting shorter and driving optimism.
  • 07/02/2020

Just one Covid-19 vaccine isn’t enough, Fauci says

  • The world needs more than one vaccine to tackle the new coronavirus, even as pharma companies race to be the first with a pandemic shot, said US infectious-disease expert Anthony Fauci.
  • 07/02/2020

New Jersey, hit hard by the coronavirus, sees positive signs

  • Gov. Phil Murphy was faced with thousands of COVID-19 cases in April — but these days he is cautiously optimistic.
  • 07/02/2020

Just one COVID-19 vaccine isn't enough: Fauci - BNN Bloomberg

  • The world needs more than one vaccine to tackle the new coronavirus, even as pharma companies race to be the first with a pandemic shot, said U.S. infectious-disease expert Anthony Fauci.
  • 07/02/2020

The U.S. Hoards Three-Month Supply of Covid-19 Drug Remdesivir

  • The Trump government inked a deal to get over 500,000 doses of the first COVID-19 drug.
  • 07/02/2020

Case of missing de-addiction tablets: Minister says health secretary acted in haste, with bias

  • The minister has now demanded an inquiry into the entire episode from the Chief Minister.
  • 07/02/2020

Berlin Heart Completes Post Approval Surveillance; Report Details Improved Outcomes for Pediatric Heart Failure Patients Supported with EXCOR® Pediatric

  • Berlin Heart completes Post Approval Surveillance; improved outcomes for pediatric heart failure patients supported with EXCOR® Pediatric
  • 07/02/2020

Many COVID-19 testing labs are at or near capacity, official says. How will they keep up?

  • Surge testing, as well as point-of-care tests, are part of a national strategy to boost testing.
  • 07/01/2020

After months of speculation, investors get excited about Pfizer, BioNTech’s coronavirus vaccine candidate

  • The path to a COVID-19 vaccine has started to come into view this week, following the stock-moving disclosures of preliminary clinical data for two...
  • 07/01/2020

After months of speculation, investors get excited about Pfizer, BioNTech’s coronavirus vaccine candidate

  • The path to a COVID-19 vaccine has started to come into view this week, following the stock-moving disclosures of preliminary clinical data for two...
  • 07/01/2020

Psychedelic mushroom legalization moves closer to appearing on Oregon ballot

  • A push to legalize the use of psychedelic mushrooms in therapeutic settings is one step closer to appearing on the Oregon ballot in November,
  • 07/01/2020

Ex-FDA chief: 500,000 people in US may be contracting coronavirus a day

  • A former head of the Food and Drug Administration said it’s possible at least a half-million people in the United States are becoming infected with the coronavirus per day.
  • 07/01/2020

Researchers Develop a New Ultrafast Insulin for Management of Blood Sugar in Diabetes

  • Researchers at Stanford University are developing a new insulin formulation that begins to take effect almost immediately upon injection, potentially working four times as fast as current commercial fast-acting insulin formulations. The researchers focused on so-called monomeric insulin, which ha
  • 07/01/2020

Sherlock, binx to develop point-of-care Covid-19 test using CRISPR technology

  • The Food and Drug Administration had previously granted an emergency use authorization for Abbott's ID NOW point-of-care test, a decision for which the agency came under fire amid reports of the test delivering inaccurate results.
  • 07/01/2020

‘Pooled testing’ for coronavirus holds promise, pitfalls

  • WASHINGTON — The nation’s top health officials are banking on a new approach to dramatically boost U.S. screening for the coronavirus: combining test samples in batches instead of running them one …
  • 07/01/2020

Coronavirus update: U.S. case tally climbs above 2.6 million and Republican leaders urge Americans to wear face masks

  • The number of confirmed cases of the coronavirus illness COVID-19 in the U.S. climbed above 2.6 million on Wednesday, a day after Dr. Anthony Fauci said it...
  • 07/01/2020

US buys nearly all global supply of remdesivir for coronavirus treatment

  • The drug manufactured by Gilead Sciences has been shown to help moderately ill COVID-19 patients recover more quickly from the disease.
  • 07/01/2020

Best ETFs for 2020: The AdvisorShares Vice ETF Bets Big on Booze

  • With the healthcare and alcohol sectors currently carrying ACT through 2020, ACT might improve its ranking in the Best ETFs contest.
  • 07/01/2020

Pfizer coronavirus vaccine candidate shows early promise

  • A coronavirus vaccine candidate from pharmaceutical company Pfizer has shown potential in healthy volunteers. Stocks jumped on the announcement Wednesday.
  • 07/01/2020

U.S. already at 100,000 new coronavirus cases a day, it just isn't testing them all, former FDA Commissioner Gottlieb says

  • "States like Texas and Florida, they're falling behind on testing right now because the testing isn't evenly distributed across the country," former FDA Commissioner Dr. Scott Gottlieb said.
  • 07/01/2020

Juul CEO Hitting the Reset Button on Vaping’s Battered Image - BNN Bloomberg

  • Trust might not be a word commonly associated with one of the most controversial companies in America. Still, it’s a word used often by K.C. Crosthwaite, chief executive officer of embattled e-cigarette maker Juul Labs Inc.
  • 07/01/2020

New FDA Guidance May Not Allow Covid-19 Vaccine This Year, Analyst Says

  • The Food and Drug Administration’s new guidance document for developers of Covid-19 vaccines doesn’t spell out a timeline. SVB Leerink analyst Geoffrey Porges says the guidelines point firmly toward no vaccine being made available until next year.
  • 07/01/2020

No Predictions, But 2 Picks for the Second Half of 2020

  • BioDelivery Sciences International and Tivity Health are two candidates investors should consider going forward.
  • 07/01/2020

Pharmalittle: White House grabs much of the remdesivir supply - STAT

  • The Trump administration says it has locked down nearly the entire supply of remdesivir, the Gilead Sciences drug, for the next several months.
  • 07/01/2020

Global Type 1 Diabetes Market Will Reach USD 2,800 Million by 2026: Facts & Factors

  • Global type 1 diabetes market is expected to grow above a CAGR of 5.0% and is anticipated to reach over USD 2,800 Million by 2026.
  • 07/01/2020

FDA Sets Bar For COVID-19 Vaccine Approval: Must Prevent Or Decrease Disease Severity For At Least Half

  • The FDA released guidance Tuesday on the criteria it will use to approve any coronavirus vaccine. Any candidates must prevent or decrease disease severity in at least 50% of the people inoculated. …
  • 07/01/2020

Ultragenyx gets second FdA approval in June

  • Shares of Ultragenyx Pharmaceutical Inc. undefined gained 1% in premarket trading on Tuesday, the day after the Food and Drug Administration approved Dojolvi...
  • 07/01/2020

UC Berkeley Launches Trial Of Saliva Test For Coronavirus

  • "As opposed to swab testing, saliva testing is a lot simpler and allows people to literally spit into a tube," Doudna said.
  • 07/01/2020

Should You Throw in the Towel on Intercept Pharmaceuticals After Its Big Setback? | The Motley Fool

  • An approval pathway for OCA in treating NASH still exists. But it appears to be a steeper path.
  • 07/01/2020

The US bought up 90% of the world's supply of remdesivir for the next 3 months, and patents mean many countries won't be able to get any

  • 07/01/2020

NIH Spearheads Study To Test At-Home Screening For HPV And Cervical Cancer

  • The National Cancer Institute plans to launch a multisite study next year involving roughly 5,000 women to assess whether self-sampling at home for the human papillomavirus that causes cervical can…
  • 07/01/2020

Coronavirus for US: New cases could rise to 1 lakh per day

  • Several southern and western states are seeing surging new case numbers, prompting some to put reopening plans on hold.NIAID director Fauci says he’s ‘aspirationally hopeful’ that a vaccine for Covid-19 will be ready in early 2021, though he cautions that there’s no guarantee that a safe vaccine will be developed
  • 07/01/2020
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