The biotech sector was in focus in the past week with quite a few regulatory and other pipeline updates. While the development of antibodies and vaccines for coronavirus remains in focus in this sector as the pandemic gains steam again, other pipeline updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
FDA Approves Gilead’s Veklury: Gilead Sciences, Inc. GILD announced that the FDA has approved its antiviral drug, Veklury (remdesivir), for the treatment of patients with COVID-19 requiring hospitalization. The drug was previously authorized by the FDA for emergency use to treat COVID-19. Veklury works to stop the replication of SARS-CoV-2, the virus that causes COVID-19. The FDA approval was based on three randomized controlled trials. These included the recently published, final results of the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled phase 3 ACTT-1 study, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19.
Novavax Jumps on COVID-19 Vaccine Development Update: Shares of Novavax, Inc. NVAX surged after it announced encouraging updates on its late-stage development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX CoV2373 is a stable, prefusion protein made using Novavax’s nanoparticle technology and includes its proprietary Matrix M adjuvant. The company has enrolled more than 5,500 participants to date in the phase III study in the U.K. The study has been expanded to 15,000 volunteers. The increased enrollment is likely to facilitate the assessment of safety and efficacy in a shorter time period. The study is expected to be fully enrolled by the end of next month. Interim data in this event-driven trial are expected as soon as early first-quarter 2021, depending on the overall COVID-19 attack rate. These data are expected to serve as the basis for global licensure. Novavax currently expects to initiate a pivotal study in the United States and Mexico by the end of November.
Amgen Announces First Patient Enrolled in COVID-19 Study: Amgen AMGN, Eisai and Global Coalition for Adaptive Research announced the enrollment of the first patient in the international COVID-19 study. The patient has been enrolled in the immune modulation domain of REMAP-COVID, a sub-study of REMAP-CAP (A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) that evaluates multiple interventions for the treatment of patients hospitalized with COVID-19. Amgen's apremilast and Eisai's investigational eritoran are being evaluated as potential therapeutic agents. Amgen’s apremilast is an oral drug, which inhibits the activity of PDE4 (Phosphodiesterase 4), an enzyme found in inflammatory cells in the human body. The study is being conducted in the multi-hospital UPMC (University of Pittsburgh Medical Center) health system along with over 20 hospitals in the United States.
Scholar Rock Jumps on Pipeline Update: Shares of clinical-stage biopharmaceutical company, Scholar Rock SRRK, jumped after it announced six-month interim analysis results from the TOPAZ phase II study. The trial is evaluating the safety and efficacy of intravenous SRK-015 dosed every four weeks (Q4W) over a 12-month treatment period in Spinal Muscular Atrophy (SMA) patients. Treatment with SRK-015 led to improvements in Hammersmith scale scores (primary efficacy endpoint) in all three cohorts of patients with Type 2 and Type 3 SMA. In addition, SRK-015 dose response in the primary efficacy endpoint was observed in the randomized, double-blind cohort, with high dose attaining a 5.6 point mean improvement at six months over baseline compared to low dose attaining a 2.4 point mean improvement over baseline. The interim data support the continuation of the TOPAZ study.
Kala Gets FDA Approval for Eye Drug: Kala Pharmaceuticals, Inc. KALA announced that the FDA has approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. The approval was based on results from four clinical trials — three phase III studies and one phase II study — which demonstrated significant improvements in the signs and symptoms of dry eye disease. The drug will be launched in the United States by year-end. However, shares of Kala were trading down despite the approval of the drug.
Kala currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 1.19% in the last four trading sessions. Among the biotech giants, Biogen lost 5.06% during this period. Over the past six months, shares of Alexion have gained 8.24%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Posts Q3 Results, VRTX Stops Study & Other Updates)
What's Next in Biotech?
Stay tuned for earnings and more pipeline updates.
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