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 gathers steam again, other pipeline updates were also in the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Submits EUA Request for Coronavirus Treatment: Regeneron REGN submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment, REGN-COV2. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. It is being evaluated for both treatment and prevention of COVID-19.
Separately, Regeneron and partner Sanofi announced that a pivotal phase III study evaluating its blockbuster inflammatory drug, Dupixent (dupilumab), to treat uncontrolled moderate-to-severe asthma in children aged 6 to 11 years met the primary and all key secondary endpoints. Data from the study showed that treatment with Dupixent plus the standard of care significantly reduced severe asthma attacks by 65% in a year in the given patient population compared to the standard of care alone. Regulatory filings for Dupixent to address this indication are expected to be submitted in the first quarter of 2021, both in the United States and Europe.
Gilead Reports Positive Results on Veklury: Gilead GILD announced the publication of positive final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled, phase III ACTT-1 trial of investigational antiviral, Veklury (remdesivir), for the treatment of adults hospitalized with mild-moderate or severe COVID-19. The results demonstrated that treatment with Veklury resulted in a faster time to recovery than previously reported. Veklury in combination with standard of care shortened the time to recovery by four days compared with placebo plus standard of care (11 days versus 15 days) in the preliminary day 15 results. Results from the final 29 days showed that Veklury achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with Veklury versus 15 days with placebo and an increased recovery rate of 29% compared with placebo.
Additionally, Gilead and Galapagos announced positive results on pipeline candidate, filgotinib, for the treatment of moderately to severely active ulcerative colitis (UC). Data from the randomized, double-blind, placebo-controlled, phase IIb/III SELECTION study showed that a significantly higher proportion of patients treated with filgotinib 200 mg achieved clinical remission at week 10 and maintained remission through week 58 as compared to placebo. In addition, significantly more patients achieved six-month corticosteroid-free remission.
Amgen Reports Data on Heart Failure Drug: Amgen AMGN along with partners Cytokinetics and Servier announced top-line data from the pivotal phase III GALACTIC-HF study, which is evaluating omecamtiv mecarbil, a novel cardiac myosin activator, developed for the treatment of heart failure with reduced ejection fraction (HFrEF). The study met the primary composite efficacy endpoint by demonstrating a statistically significant effect to reduce cardiovascular (CV) death or heart failure events when treated with omecamtiv mecarbil as compared to placebo. However, omecamtiv mecarbil failed to achieve the secondary endpoint of reduction in CV death in the given patient population. Adverse events, including major ischemic cardiac events, were balanced between treatment arms.
Avenue Therapeutics Tanks on Complete Response Letter: Shares of Avenue Therapeutics, Inc. ATXI plunged after it announced the receipt of a Complete Response Letter (“CRL”) from the FDA regarding its New Drug Application (“NDA”) for IV tramadol.
The CRL stated that although the phase III studies demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the agency has determined that it cannot approve the application in its present form. Per the CRL, IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. In addition, the CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.
Bristol Myers Gains on Positive Opdivo Data in NSCLC: Bristol Myers BMY announced positive results from a late-stage study on immuno-oncology drug, Opdivo (nivolumab), in the lucrative indication of non-small cell lung cancer (NSCLC).
The phase III randomized, open-label, multi-center study — CheckMate -816 — is evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC. The study met the primary endpoint of improved pathologic complete response (pCR) in patients who received Opdivo plus chemotherapy before surgery. The study results showed that significantly more patients treated with Opdivo plus chemotherapy before surgery did not show any evidence of cancer cells in their resected tissue as compared to those treated with only chemotherapy.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vaxart Up on Dosing of First Patient in Coronavirus Study: Clinical-stage biotechnology company, Vaxart, Inc. VXRT gained after it announced that the first subject has been dosed in its phase I study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate. The phase I, open-label, dose-ranging study is designed to examine the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years. Enrollment is expected to be completed by early next month, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet on days 1 and 29.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 4.55% in the last five trading sessions. Among the biotech giants, Incyte gained 9.57% during this period. Over the past six months, shares of Alexion have gained 28.19%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN to Raise Guidance, BMY to Buy MYOK & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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