The biotech sector was in focus with key updates this week. Biotech major Regeneron REGN is buying back a part of its stake from partner Sanofi’s SNY. Meanwhile, as the pandemic spreads further, the spotlight in the biotech sector remains on companies developing treatments for coronavirus. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19 and updates from these companies continue to cheer investors in the hope of a possible treatment soon.
Recap of the Week’s Most Important Stories:
Regeneron to Buy Back Stake From Sanofi: Regeneron announced that it has initiated an underwritten public secondary offering of its common stock, whereby its long-standing partner Sanofi will offload its stake in the former raising close to $7.3 billion. The surge in the share price has most likely prompted Sanofi to divest the stake as it looks to focus on lucrative avenues such as oncology. As of now, Sanofi holds approximately 23.2 million Regeneron shares and plans to sell approximately 12.8 million shares in an underwritten public offering. Sanofi also expects to grant the underwriters a 30-day option to purchase an additional 10% of the shares provided in the base offer. Regeneron will also repurchase approximately $5 billion of common stock directly from Sanofi, following the close of the secondary offering. The purchase will be funded with a combination of $3.5 billion of cash in hand and $1.5 billion of fully-committed bridge financing from Goldman Sachs Bank USA.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novavax Surges on COVID-19 Vaccine Update: Shares of Novavax NVAX surged after it announced the enrollment of the first participant in a phase I/II study on its coronavirus vaccine candidate, NVX CoV2373. The candidate includes Novavax’s proprietary Matrix M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. The company expects preliminary immunogenicity and safety results from the phase I portion of the study in July 2020. The study is being conducted in two parts. The phase I portion is a randomized, observer-blinded, placebo-controlled study designed to evaluate the immunogenicity and safety of NVX CoV2373, both adjuvanted with Matrix M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The phase II portion is likely to be conducted in multiple countries, including the United States. This part will assess the immunity, safety and COVID 19 disease reduction in a broader age range.
argenx Soars on Study Data: Shares of argenx ARGX soared after it announced positive top-line data from the pivotal study — ADAPT — evaluating intravenous (“IV”) administration of its lead pipeline candidate, efgartigimod, in patients with myasthenia gravis (“MG”), which is a rare neurological autoimmune disease. Data from the study showed that the candidate met the study’s primary endpoint. The positive data raises hopes for a potential approval. The company also announced plans to file a biologics license application (“BLA”) seeking approval for efgartigimod as a treatment for MG patients to the FDA by the end of 2020.
Inovio Surges on Vaccine Data: Inovio INO surged following the announcement of preclinical study data for IN0-4800, its COVID-19 DNA vaccine. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibodies as well as T cell responses in mice and guinea pigs. Moreover, data showed virus-neutralizing activities using three separate neutralization assays testing the vaccine's ability to generate antibodies, which can block virus infection, by — 1) an assay using live SARS-CoV-2 viruses; 2) an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and, 3) a novel high-throughput surrogate neutralization assay measuring the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor. The preliminary safety and immune responses data from the Phase 1 clinical trial are expected in June.
Intercept Down on Delay in AdCom Meet: Intercept’s ICPT shares declined after it announced that the FDA has postponed the advisory committee meeting (AdCom), which was scheduled on Jun 9, 2020, regarding its new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH). Per the press release, this delay will accommodate the review of additional data requested by the regulatory body, which Intercept plans to submit within the next week. The FDA will issue a new proposed AdCom date in the future.
Earlier, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Jun 26, 2020, for the completion of the review of the NDA seeking approval of OCA for liver fibrosis due to NASH. The company now expects this date to get extended as well.
The Nasdaq Biotechnology index lost 0.15% in the last four trading sessions. Among the biotech giants, Incyte gained 3.96% during this period. Over the past six months, shares of Regeneron have gained 49.85%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA, DVAX Up on Coronavirus Treatment Updates, & More).
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
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Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Inovio Pharmaceuticals, Inc. (INO) : Free Stock Analysis Report Intercept Pharmaceuticals, Inc. (ICPT) : Free Stock Analysis Report ARGENX SEADR (ARGX) : Free Stock Analysis Report To read this article on Zacks.com click here.