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Biotech Stock Roundup: BIIB's Q3 Earnings, REGN's COVID-19 Cocktail Update & More

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It has been a busy week for the biotech sector with quite a few regulatory and pipeline updates. While the development of coronavirus treatments and subsequent progress on the same continues to be in the spotlight, other regulatory and pipeline updates were also in the spotlight.

Recap of the Week’s Most Important Stories:

Biogen Beats on Q3 Sales, EarningsBiogen (BIIB - Free Report) beat on both earnings and sales in the third quarter. The company also upped its guidance.  However, management stated that the uptake of the much-hyped recently approved Alzheimer’s disease (AD) treatment, Aduhelm, has been slow.

Regeneron BLA for Antibody Cocktail Accepted: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has accepted its Biologics License Application (BLA) for antibody cocktail REGEN-COV (casirivimab and imdevimab). The BLA is seeking approval of the candidate to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has granted Priory Review to the candidate and set a target action date of Apr 13, 2022. A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year. REGEN-COV is currently authorized under an Emergency Use Authorization to treat patients with mild to moderate COVID-19.

Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Label Expansion of Gilead’s BiktarvyGilead (GILD - Free Report) announced the FDA has approved a supplemental new drug application (sNDA) for flagship HIV therapy Biktarvy.  The regulatory body approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The label expansion of Biktarvy is based on data from Cohort 3 of phase II/III open-label, single-arm study. Data from the study showed that Biktarvy low-dose tablets were effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing ≥14 to <25 kg who remained on treatment for 48 weeks and could then continue to receive study drug through an extension phase.

The company also announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion on the Marketing Authorization Application (MAA) for sacituzumab govitecan. The MAA is seeking approval of the candidate as a monotherapy indicated for adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.

Atea Plunges on COVID-19 Drug Study: Shares of Atea Pharmaceuticals, Inc. (AVIR - Free Report) plunged significantly after the company announced that the phase II study evaluating its oral COVID-19 drug candidate, AT-527, failed. The phase II MOONSONG study evaluating AT-527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 compared to placebo in the overall study population, of which approximately two-thirds of patients were low-risk with mild symptoms.  Nevertheless, the treatment with AT-527 demonstrated a reduction of viral load in high-risk patients with underlying health conditions.

Valneva Surges on COVID-19 Vaccine Study Update:  Shares of Valneva (VALN - Free Report) surged after the company announced positive top-line results from the phase III study Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.  The study met its co-primary endpoints as VLA2001 demonstrated superiority against AstraZeneca’s (AZN - Free Report) AZD1222 (ChAdOx1-S), in terms of geometric mean titer for neutralization antibodies as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination (i.e. day 43) in adults aged 30 years and older. VLA2001 was well tolerated, demonstrating a statistically significant better tolerability profile compared to the active comparator vaccine. VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S, M, and N proteins.



Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology Index has gained 0.88% in the past five trading sessions. Among the biotech giants, Moderna has gained 7.23% during the period. Over the past six months, shares of Moderna have soared 106.05%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNAs Vaccine Update, GILDs CAR T Therapy Label Expansion).

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What's Next in Biotech?

Stay tuned for more pipeline and regulatory updates.