Biotech Stock Roundup: Biotech Stocks Soar On Election Results, Gilead HBV Drug Approved
Zacks Investment Research | Nov 15, 2016 08:12PM ET
Earnings reports, pipeline updates and regulatory news were overshadowed by the run-up to the Presidential election and the surprise win of Donald Trump. In fact, the biotech sector responded favorably to Trump’s victory on hopes that there will be fewer drug pricing headwinds considering Trump was not as vocal as Hillary Clinton about rising drug prices and excessive price hikes. Trump’s pro-business stand is also expected to benefit the sector.
Recap of the Week’s Most Important Stories
Gilead HBV Drug Gains FDA Approval: Gilead (NASDAQ:GILD) , which is facing a slowdown in hepatitis C virus (HCV) franchise sales, gained FDA approval for Vemlidy (tenofovir alafenamide, TAF), a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Approval comes with a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of HBV. With HBV being an under-treated disease that affects up to 2.2 million in the U.S., Vemlidy provides patients with a new treatment option.
Vemlidy also got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (Read more: the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Dynavax Plunges on Heplisav-B CRL: Dynavax’s shares plunged almost 65% on a complete response letter (CRL) from the FDA for Heplisav-B. The company was looking to get Heplisav-B approved for the immunization of adults against hepatitis B infection.
While the agency said that it is yet to complete the review of information submitted by Dynavax in early October, the CRL has asked for information on several topics including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. This is the second time that Dynavax has received a CRL for Heplisav-B. Dynavax said that given the time and resources that will be needed to gain approval, it may not be able to advance the program on its own and is looking for a pharmaceutical or financial partner.
FDA Lifts Partial Clinical Hold on Adaptimmune Treatment: The FDA has removed the partial clinical hold on Adaptimmune’s planned study of its NY-ESO SPEAR T-cell therapy in myxoid/round cell liposarcoma (MRCLS). The company will now commence a pilot study under a revised protocol with patient screening scheduled to start in the fourth quarter. The partial clinical hold was announced in August and had nothing to do with safety. The agency had asked the company to provide additional CMC information and clarification of certain study design-related queries before the commencement of the study.
Get The News You Want
Performance
Medical - Biomedical and Genetics Industry Price Index
Ionis Soars on Spinraza Data, Regeneron's Q3 Results Mixed ).
What's Next in the Biotech World?
With third quarter earnings season drawing to a close, watch out for pipeline and regulatory updates.
Confidential: Zacks' Best Investment Ideas
Would you like to see a hand-picked "all-star" selection of investment ideas from the man who heads up Zacks' trading and investing services? Steve Reitmeister knows when key trades are about to be triggered and which of our experts has the hottest hand. Original post
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.