Coronavirus treatment updates continue to grab the spotlight in the biotech sector, given the severity of the spread. The biotech companies continue to evaluate both treatments for the infected and prevention of the contagion. Meanwhile, other regulatory and pipeline updates were also in focus this week.
Recap of the Week’s Most Important Stories:
Gilead's Coronavirus Drug Gets Conditional Approval in Europe: Gilead Sciences, Inc. GILD announced that the European Commission has granted conditional marketing authorization to Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19.
Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) with pneumonia requiring supplemental oxygen. Given the alarming levels of the spread of the pandemic and the urgent need for a treatment, the conditional marketing authorization was granted based on a rolling review of supporting data that began in April 2020.
A conditional marketing authorization in Europe is initially valid for one year but can be extended to or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data. The authorization for Veklury is supported by the U.S. National Institute of Allergy and Infectious Diseases’ global phase III study of remdesivir.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron Initiates Studies on Experimental Coronavirus Drug: Shares of Regeneron Pharmaceuticals, Inc. REGN gained after it announced the initiation of late-stage studies on experimental coronavirus candidate, REGN-COV2.
REGN-COV2 is Regeneron's investigational double-antibody cocktail, which is being evaluated both for the treatment and prevention of COVID-19. A phase III study will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate). The study is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The phase III prevention trial is being conducted at approximately 100 sites and expected to enroll 2,000 patients in the United States. The trial will assess SARS-CoV-2 infection status. The two phase II/III treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the United States, Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer.
Novovax Surges on Funding for Coronavirus Program: Shares of Novovax, Inc. NVAX jumped after its coronavirus vaccine candidate was selected for the U.S. government’s Operation Warp Speed. The company was awarded $1.6 billion by the federal government to support the late-stage development of its coronavirus vaccine candidate, NVX-CoV2373. The funding will also help the company accomplish large-scale manufacturing and delivery of 100 million doses of NVX-CoV2373, as early as late 2020. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a phase III study with up to 30,000 subjects beginning fall 2020.
Corvus Surges on Coronavirus Study Initiation: Shares of Corvus Pharmaceuticals CRVS soared after it announced the initiation of a phase I study to investigate a novel immunotherapy approach for patients with COVID-19. The study is expected to enroll up to 30 patients at several sites in the United States. The initiation follows the FDA’s review and acceptance of the company’s investigational new drug (IND) application for the COVID-19 study. Corvus is evaluating an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006. The open-label, phase I study is expected to enroll up to 30 COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg), escalating in four cohorts as the study progresses. Patients will receive medications, therapies and interventions per standard treatment protocols for COVID-19 for the duration of the study.
Amgen Gets Favorable Ruling for Enbrel: Amgen AMGN announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of the company on the validity of two patents for Enbrel (etanercept) against Novartis’ generic arm, Sandoz. The United States Court of Appeals for the Federal Circuit affirmed the August 2019 decision of a district court of New Jersey that had also upheld the validity of the two patents. The patent infringement action was brought against Sandoz by Amgen affiliates — Immunex Corporation and Amgen Manufacturing, Limited — along with the owner and licensor of the two patents, Hoffmann-La Roche Inc. Sandoz acknowledged its biosimilar etanercept infringes seven claims of U.S. Patent Nos. 8,063,182 and 8,163,522 (the '182 and '522 patents) before the trial.
The Nasdaq Biotechnology index gained 2.45% in the last four trading sessions. Among the biotech giants, Amgen gained 7.33% during this period. Over the past six months, shares of Regeneron have gained 71.5%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Prices Remdesivir, VXRT Rises, ICPT Plunges & More)
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel coronavirus.
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Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Corvus Pharmaceuticals, Inc. (CRVS) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research