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Biotech Stock Roundup: REGN's Cancer Drug Positive, COVID-19 Updates From NVAX & More

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The biotech sector continues to be in focus as the development of antibodies and vaccines for coronavirus is gaining importance with each passing day, with the pandemic refusing to die out. Other pipeline and regulatory updates also grabbed the spotlight.

Recap of the Week’s Most Important Stories

Gilead, Merck to Develop HIV Treatments: Gilead Sciences, Inc. (GILD - Free Report) announced a collaboration agreement with pharma giant Merck to co-develop and co-commercialize long-acting treatments in HIV. The companies have collaborated to evaluate Gilead’s investigational capsid inhibitor, lenacapavir, with Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, to form a two-drug regimen for HIV patients.

Both candidates are currently in late-stage development and have demonstrated activity at low dosages in clinical studies.  The first studies of the oral combination are expected to begin in the second half of 2021. Per the terms, Gilead and Merck will share operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues.

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, Sanofi’s Libtayo Positive for Cervical Cancer: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the phase III study evaluating the PD-1 inhibitor Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy, whose cervical cancer is recurrent or metastatic, demonstrated an overall survival (OS) benefit. Patients in the study were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine).

Notably, the subjects receiving Libtayo experienced a 31% reduced risk of death. Among these, patients with squamous cell carcinoma experienced a 27% reduced risk of death while adenocarcinoma patients experienced a 44% reduced risk of death.

Significantly, based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), the study will be stopped early and the data will form the basis of regulatory submissions later in the year. Libtayo is already approved for advanced cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (NSCLC) and basal cell carcinoma (BCC).

Novavax’s Vaccine Effective Against Original & Variant COVID-19 StrainsNovavax, Inc (NVAX - Free Report) announced impressive data from a phase III trial in the United Kingdom of its vaccine candidate, NVX–CoV237, against COVID-19. Data showed a final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19. 

The company also announced a complete analysis of its phase IIb study taking place in South Africa, with an efficacy of 55.4% among the HIV-negative trial participants in a region where the vast majority of strains are B1.351 escape variants. The vaccine candidate demonstrated 100% protection against severe disease, including all hospitalization and death in both studies. Both studies achieved their statistical success criteria.

Translate Bio Gains on Vaccine Update: Shares of Translate Bio (TBIO - Free Report) gained after the company and partner Sanofi Pasteur, the vaccines global business unit of Sanofi, announced the initiation of the phase I/II study on MRT5500, a COVID-19 vaccine candidate. The phase I/II study is a randomized, double-blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500.

Approximately 415 healthy adults aged 18 years or older are expected to be enrolled in the trial across 13 investigational sites. The participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated (15µg, 45µg or 135µg). Consequently, Translate Bio will receive a $25-million payment based on the achievement of this milestone. Interim results from this study are expected in the third quarter of 2021.

Vir’s Antibody for COVID-19 Positive: Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline plc (GSK - Free Report) announced that an Independent Data Monitoring Committee (IDMC) has recommended that its late-stage study evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization should pause enrollment due to evidence of profound efficacy.

An interim analysis of data from 583 patients enrolled in the COMET-ICE study demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. The candidate was well tolerated. Consequently, the IDMC recommended the trial be stopped early.

Based on these results, both the companies plan to submit an Emergency Use Authorization (EUA) application to the FDA and regulatory authorities in other countries. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.

Performance

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 gained 6.78% in the last five trading sessions. Among the biotech giants, Regeneron gained 4.48% during the period. Over the past six months, shares of Alexion have surged 31.67%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN’s Acquisition, ACAD’s Regulatory Update & More)

What's Next in Biotech?

Stay tuned for more pipeline and regulatory updates.

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