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Biotech Stock Roundup: GILD, BLUE, AXSM's Drug Approvals, FHTX Study Update & More
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Drug approvals and other regulatory updates are in focus in the biotech sector. COVID-19 vaccine news is also back in the spotlight.
Recap of the Week’s Most Important Stories:
Gilead’s HIV Treatment Gets EC Approval: Gilead Sciences, Inc. (GILD - Free Report) announced that its HIV treatment Sunlenca (lenacapavir) has been approved by the European Commission (“EC”). The EC has granted marketing authorization to Sunlenca injection and tablets for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
The phase II/III CAPELLA study evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced. Of the participants, 83% receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52.
Per the company, most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes. In addition, Sunlenca is the only HIV treatment option administered twice yearly. The approval will strengthen Gilead’s strong HIV portfolio.
Axsome Up on Drug Approval: Shares of Axsome Therapeutics, Inc. (AXSM - Free Report) surged following FDA’s approval of Auvelity (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. The drug was studied in a comprehensive clinical program that included more than 1,100 patients with depression. Per the company, following the FDA nod, Auvelity became the first and only rapid-acting oral medicine to be approved for the treatment of MDD with the labeling of statistically significant antidepressant efficacy versus placebo starting at week one. The new drug application (NDA) was evaluated by the FDA under Priority Review, which is granted by the FDA for applications in medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
bluebird Wins FDA Nod for Gene Therapy: bluebird (BLUE - Free Report) announced that the FDA has approved Zynteglo (betibeglogene autotemcel), as one-time gene therapy for treating beta-thalassemia, in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Zynteglo offers potentially curative benefits across ages and genotypes through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels. Zynteglo was reviewed under Priority Review, and bluebird received a Priority Review voucher upon approval. The therapy was previously granted Orphan Drug designation and Breakthrough Therapy designation. The approval was expected as the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted unanimously (13-0) that the benefits of beti-cel gene therapy outweigh the risks for patients with beta-thalassemia who require regular RBC transfusions.
Novavax Vaccine Gets EUA for Adolescents: Novavax, Inc. (NVAX - Free Report) announced that the FDA expanded its emergency use authorization (EUA) for its COVID-19 vaccine, adjuvanted (NVX-CoV2373), for use in adolescents aged 12 through 17 years in the United States. This label expansion is based on data from the ongoing pediatric expansion of phase III PREVENT study, which evaluated NVX-CoV2373 in 2,247 adolescents. The study achieved its primary efficacy endpoint of NVX-CoV2373 generating neutralizing antibodies in adolescents, similar to the antibody responses in young adult participants (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT study. The antibody responses were 1.5-fold higher in adolescents than young adults.
Foghorn Study on Full Clinical Hold: Shares of Foghorn Therapeutics Inc. (FHTX - Free Report) declined after the FDA placed a full clinical hold on the phase I dose escalation study of pipeline candidate FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.
Earlier, in May, the regulatory body had placed the study on a partial clinical hold following the report of a death in a subject with potential differentiation syndrome. Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286. The FDA observed additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 in the data submitted in response to the partial hold.
Consequently, the FDA has placed a full clinical hold on the AML/MDS study. The regulatory body has additional questions and requires further analyses before the clinical hold may be lifted.
Performance
The Nasdaq Biotechnology Index have lost 5.51% in the past five trading sessions. Among the biotech giants, Moderna has lost 14.40% during the period. Over the past six months, shares of Vertex have surged 24.08%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD’s Drug News, NVAX & MRNA COVID-19 Vaccine Updates)
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What's Next in Biotech?
Stay tuned for earnings and other updates.
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Biotech Stock Roundup: GILD, BLUE, AXSM's Drug Approvals, FHTX Study Update & More
Drug approvals and other regulatory updates are in focus in the biotech sector. COVID-19 vaccine news is also back in the spotlight.
Recap of the Week’s Most Important Stories:
Gilead’s HIV Treatment Gets EC Approval: Gilead Sciences, Inc. (GILD - Free Report) announced that its HIV treatment Sunlenca (lenacapavir) has been approved by the European Commission (“EC”). The EC has granted marketing authorization to Sunlenca injection and tablets for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
The phase II/III CAPELLA study evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced. Of the participants, 83% receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52.
Per the company, most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes. In addition, Sunlenca is the only HIV treatment option administered twice yearly. The approval will strengthen Gilead’s strong HIV portfolio.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Axsome Up on Drug Approval: Shares of Axsome Therapeutics, Inc. (AXSM - Free Report) surged following FDA’s approval of Auvelity (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. The drug was studied in a comprehensive clinical program that included more than 1,100 patients with depression. Per the company, following the FDA nod, Auvelity became the first and only rapid-acting oral medicine to be approved for the treatment of MDD with the labeling of statistically significant antidepressant efficacy versus placebo starting at week one. The new drug application (NDA) was evaluated by the FDA under Priority Review, which is granted by the FDA for applications in medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
bluebird Wins FDA Nod for Gene Therapy: bluebird (BLUE - Free Report) announced that the FDA has approved Zynteglo (betibeglogene autotemcel), as one-time gene therapy for treating beta-thalassemia, in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Zynteglo offers potentially curative benefits across ages and genotypes through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels. Zynteglo was reviewed under Priority Review, and bluebird received a Priority Review voucher upon approval. The therapy was previously granted Orphan Drug designation and Breakthrough Therapy designation. The approval was expected as the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted unanimously (13-0) that the benefits of beti-cel gene therapy outweigh the risks for patients with beta-thalassemia who require regular RBC transfusions.
Novavax Vaccine Gets EUA for Adolescents: Novavax, Inc. (NVAX - Free Report) announced that the FDA expanded its emergency use authorization (EUA) for its COVID-19 vaccine, adjuvanted (NVX-CoV2373), for use in adolescents aged 12 through 17 years in the United States. This label expansion is based on data from the ongoing pediatric expansion of phase III PREVENT study, which evaluated NVX-CoV2373 in 2,247 adolescents. The study achieved its primary efficacy endpoint of NVX-CoV2373 generating neutralizing antibodies in adolescents, similar to the antibody responses in young adult participants (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT study. The antibody responses were 1.5-fold higher in adolescents than young adults.
Foghorn Study on Full Clinical Hold: Shares of Foghorn Therapeutics Inc. (FHTX - Free Report) declined after the FDA placed a full clinical hold on the phase I dose escalation study of pipeline candidate FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.
Earlier, in May, the regulatory body had placed the study on a partial clinical hold following the report of a death in a subject with potential differentiation syndrome. Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286. The FDA observed additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 in the data submitted in response to the partial hold.
Consequently, the FDA has placed a full clinical hold on the AML/MDS study. The regulatory body has additional questions and requires further analyses before the clinical hold may be lifted.
Performance
The Nasdaq Biotechnology Index have lost 5.51% in the past five trading sessions. Among the biotech giants, Moderna has lost 14.40% during the period. Over the past six months, shares of Vertex have surged 24.08%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD’s Drug News, NVAX & MRNA COVID-19 Vaccine Updates)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for earnings and other updates.