It was a busy week for the biotech sector with drug approvals and regular pipeline and regulatory updates. Vaccines and antibodies for COVID-19 are also in spotlight.
Recap of the Week’s Most Important Stories:
Sage Down on Depressive Disorder Study Results: Shares of Sage Therapeutics SAGE fell after it announced results from the WATERFALL study on zuranolone, an investigational two-week, once-daily therapeutic being evaluated for major depressive disorder, conducted in partnership with Biogen BIIB.
The study met its primary endpoint as zuranolone 50 mg showed a statistically significant improvement in depressive symptoms compared with placebo at day 15, as assessed by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. Moreover, rapid onset of treatment effect was seen in HAMD-17 results at days 3, 8 and 12.
However, HAMD-17 scores reduced over the course of the treatment. Patients treated with the candidate retained, on average, 86.1% of their HAMD-17 improvement after four weeks of completion of the 14-day treatment regimen. The study also did not meet statistical significance for the secondary endpoint. Hence, investors were disappointed and shares fell.
Regulatory & Pipeline Updates From Vertex: Vertex Pharmaceuticals VRTX announced that the FDA approved the expanded use of its cystic fibrosis drug, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor). The drug’s label has been expanded to include children with cystic fibrosis (CF) aged 6 to 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. It was previously approved by the FDA for use in cystic fibrosis patients 12 years and older.
Vertex also announced that it will not advance VX-864 into late-stage development. The candidate achieved rapid, consistent and statistically significant increases in mean functional alpha-1 antitrypsin (fAAT) levels of 2.2 to 2.3 micromolar from baseline in people with alpha-1 antitrypsin deficiency (AATD) with the PiZZ genotype, across three dose groups of VX-864 compared to placebo in a phase II proof-of-concept study.
Although results provide proof of mechanism, the magnitude of treatment effect observed in this study is unlikely to translate into substantial clinical benefit and hence, the company will not develop it any further.
Regeneron Announces Data on REGEN-COV: Regeneron Pharmaceuticals, Inc. REGN announced positive results on its antibody cocktail, REGEN-COV, from the RECOVERY trial in the U.K. The RECOVERY trial (Randomised Evaluation of COVid-19 thERapY) was conducted by the registered clinical trial units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine.
Results showed that adding investigational REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own. Earlier, late-stage studies in non-hospitalized COVID-19 patients have shown that REGEN-COV reduced viral levels, shortened the time to resolution of symptoms and significantly reduced the risk of hospitalization or death.
REGEN-COV is currently authorized in the United States under an Emergency Use Authorization (EUA) to treat mild-to-moderate COVID-19 in adults and pediatric patients. Regeneron will share new data with regulatory authorities immediately and request the EUA to be expanded to include appropriate hospitalized patients.
Regeneron currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
iTeos Surges on Glaxo Deal: Shares of iTeos Therapeutics ITOS surged after it announced a deal with GlaxoSmithKline plc GSK to co-develop and co-commercialize EOS-448. The candidate is an anti-TIGIT monoclonal antibody and currently, in an open-label phase I study in patients with advanced solid tumors. Glaxo and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022.
Per the terms of the agreement, iTeos will receive an upfront payment of $625 million. It is also eligible to receive up to an additional $1.45 billion in milestone payments. Glaxo and iTeos will share responsibilities and costs for the global development of EOS-448 and jointly commercialize and equally split profits in the United States. Glaxo will receive an exclusive license for commercialization and iTeos will receive tiered royalty payments outside of the United States.
Positive Data on Novavax’s COVID-19 Vaccine: Novavax, Inc. NVAX announced that the phase III PREVENT-19 study evaluating its adjuvanted protein-based coronavirus vaccine candidate, NVX-CoV2373, in the United States and Mexico met its primary endpoint. Results from the study showed overall vaccine efficacy of 90.4%.
The vaccine also provided 100% protection against moderate and severe disease. NVX-CoV2373 also showed success among "high-risk" populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure). Novavax intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 0.62% in the last five trading sessions. Among the biotech giants, Bristol-Myers gained 5.84% during the period. Over the past six months, shares of Biogen have surged 59.24%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB's Drug Approval, ALXN Drug Label Expansion & More).
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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