Regeneron (REGN - Free Report) and several mid-and small-cap biotech stocks reported earnings results while companies like Dynavax (DVAX - Free Report) and AbbVie (ABBV - Free Report) provided regulatory updates.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Regeneron reported a strong quarter with the company surpassing both earnings and revenue estimates on the back of Eylea sales. The company raised its 2017 outlook for Eylea as well (Read more: Regeneron Beats on Q2 Earnings & Sales, Raises View). Immuno-oncology focused companies like Juno (Read more: Juno Therapeutics Q2 Loss Widens, Revenues Surpass) and Kite (KITE - Free Report) also reported second quarter results. Kite has a key regulatory event coming up later this year with the FDA expected to respond on the approval status of the company’s CAR-T treatment, axicabtagene ciloleucel, by Nov 29, 2017. The investigational treatment has been submitted for review in the EU as well for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) in patients who are ineligible for autologous stem cell transplant.
Regeneron is a Zacks Rank #1 (Strong Buy) stock -- you can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax Hepatitis B Vaccine PDUFA Date Pushed Back by 3 Months: Dynavax, which got a favorable vote from an FDA advisory panel for its investigational hepatitis B vaccine Heplisav-B, is facing a delay in getting the vaccine approved with the FDA asking for detailed information on the company's proposed post-marketing study for the treatment. The advisory panel, which had voted 12 to 1 in favor of the safety data for Heplisav-B, had commented on the design of Dynavax's proposed post-marketing study. Based on this, the company and the FDA agreed that more time is needed to finalize key details of the post-marketing study. As a result, the FDA action date was pushed back by three months to Nov 10, 2017. The company still expects to launch Heplisav-B in the U.S. in early 2018. Dynavax’s shares are up a whopping 372.2% year to date, significantly outperforming the industry’s 9.7% rally.
AbbVie’s New HCV Treatment Gets FDA Nod: AbbVie’s 8-week, pan-genotypic, ribavirin-free, once-daily hepatitis C virus (HCV) treatment, Mavyret, gained FDA approval for use in HCV patients without cirrhosis and who are new to treatment. With this approval, competition in the HCV market is going to heat up further. According to AbbVie, Mavyret may be used in up to 95% of HCV patients, depending on the stage of liver disease and prior treatment history. The company said that about 3.4 million Americans are chronically infected with HCV. Mavyret gained EU approval recently.
FibroGen Hits 52-Week High on IPF Drug Data: FibroGen’s (FGEN - Free Report) shares shot up 48.2% on positive data on the company’s investigational idiopathic pulmonary fibrosis (IPF) drug, pamrevlumab, from a mid-stage study as well as two combination safety sub-studies. The proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody is being evaluated in fibrotic disease and cancer. The IPF indication represents huge commercial potential – IPF or abnormal scarring of the lungs is a rare and serious lung disease with survival rates comparable to those of some of the deadliest cancers. If approved, pamrevlumab could bring in significant sales for FibroGen. Currently approved IPF drugs include Esbriet and Ofev (Read more: Why Did FibroGen Stock Hit All-Time High Today?).
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 0.5% over the last five trading sessions. Among major biotech stocks, Celgene (CELG - Free Report) and Vertex (VRTX - Free Report) recorded minimal gains while Gilead lost 3.2% reflecting the impact of the approval of AbbVie’s new HCV drug. Over the last six months, Vertex was up 74.7% (See the last biotech stock roundup here: Q2 Earnings from Gilead, CELG & More, Dynavax Up on Panel Vote).
What's Next in the Biotech World?
Watch out for earnings reports from small and mid-cap biotechs as well as the usual regulatory and pipeline updates.
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