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Biotech Stock Roundup: VIR Down on Regulatory News, BMY Offers Updates & More
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The biotech sector has been in focus in the past week on some important pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Updates From Bristol Myers: Bristol Myers (BMY - Free Report) announced that the European Commission (“EC”) has approved its Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (“DLBCL”), primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B), following two or more lines of systemic therapy.
Earlier, the EC also approved a label expansion of its blockbuster drug Opdivo (nivolumab)-based combinations for several indications. The drug has been approved in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%. The regulatory body also approved Opdivo in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥ 1%. The EC also approved Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection.
Setback for Vir Biotechnology: Shares of Vir Biotechnology, Inc. (VIR - Free Report) tanked after the FDA determined that investigational monoclonal antibody sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant. Vir Biotechnology has a collaboration agreement with GlaxoSmithKline for the same.
Last week, the FDA amended the Emergency Use Authorization (EUA) for sotrovimab based on new data, which showed that it was unlikely for sotrovimab 500 mg dose to be effective against the dominant Omicron BA.2 variant. Thereafter, the agency updated its website to exclude sotrovimab’s use in regions where the infection is caused by a non-susceptible SARS-CoV-2 variant based on available information, including variant susceptibility to these drugs and regional variant frequency (HHS regions 1 and 2). The regulatory body has now extended the exclusion to all U.S. regions due to increases in COVID-19 cases caused by the Omicron BA.2 sub-variant.
Consequently, both Vir Biotechnology and Glaxo are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant. They are sharing these data with regulatory and health authorities worldwide for discussion.
Gilead’s Yescarta Approval for LBCL: Gilead Sciences, Inc. (GILD - Free Report) ’s company Kite announced that the FDA approved CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The results of the landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment. Gilead's Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy.
Vertex Announces Data on Pain Candidate: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced positive results from two phase II proof-of-concept (POC) studies that evaluated its selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. The phase II study was a randomized, double-blind, placebo-controlled, dose-ranging study that evaluated three different doses of VX-548 administered orally over 36 hours in 274 patients with acute pain following bunionectomy surgery. The study also included a hydrocodone bitartrate/acetaminophen reference arm (5 mg/325 mg administered orally every six hours over 42 hours). Treatment with the NaV1.8 inhibitor VX-548 met the primary endpoint in both phase II proof-of-concept acute pain studies following abdominoplasty or bunionectomy surgery.
The results further highlight NaV1.8 as a new mechanism that could create an alternative to opioids for the treatment of pain. Vertex plans to advance VX-548 into pivotal development in acute pain in the second half following discussions with regulators.
Performance
Image Source: Zacks Investment Research
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 1.76% in the past five trading sessions. Among the biotech giants, Vertex has gained 6.19% during the period. Over the past six months, shares of Moderna have lost 48.87%. (See the last biotech stock roundup here: Biotech Stock Roundup: AXSM to Acquire JAZZ's Drug, IGMS Up on SNY Deal & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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Biotech Stock Roundup: VIR Down on Regulatory News, BMY Offers Updates & More
The biotech sector has been in focus in the past week on some important pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Updates From Bristol Myers: Bristol Myers (BMY - Free Report) announced that the European Commission (“EC”) has approved its Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (“DLBCL”), primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B), following two or more lines of systemic therapy.
Earlier, the EC also approved a label expansion of its blockbuster drug Opdivo (nivolumab)-based combinations for several indications. The drug has been approved in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%. The regulatory body also approved Opdivo in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥ 1%. The EC also approved Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection.
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.
Setback for Vir Biotechnology: Shares of Vir Biotechnology, Inc. (VIR - Free Report) tanked after the FDA determined that investigational monoclonal antibody sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant. Vir Biotechnology has a collaboration agreement with GlaxoSmithKline for the same.
Last week, the FDA amended the Emergency Use Authorization (EUA) for sotrovimab based on new data, which showed that it was unlikely for sotrovimab 500 mg dose to be effective against the dominant Omicron BA.2 variant. Thereafter, the agency updated its website to exclude sotrovimab’s use in regions where the infection is caused by a non-susceptible SARS-CoV-2 variant based on available information, including variant susceptibility to these drugs and regional variant frequency (HHS regions 1 and 2). The regulatory body has now extended the exclusion to all U.S. regions due to increases in COVID-19 cases caused by the Omicron BA.2 sub-variant.
Consequently, both Vir Biotechnology and Glaxo are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant. They are sharing these data with regulatory and health authorities worldwide for discussion.
Gilead’s Yescarta Approval for LBCL: Gilead Sciences, Inc. (GILD - Free Report) ’s company Kite announced that the FDA approved CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The results of the landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment. Gilead's Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy.
Vertex Announces Data on Pain Candidate: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced positive results from two phase II proof-of-concept (POC) studies that evaluated its selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. The phase II study was a randomized, double-blind, placebo-controlled, dose-ranging study that evaluated three different doses of VX-548 administered orally over 36 hours in 274 patients with acute pain following bunionectomy surgery. The study also included a hydrocodone bitartrate/acetaminophen reference arm (5 mg/325 mg administered orally every six hours over 42 hours). Treatment with the NaV1.8 inhibitor VX-548 met the primary endpoint in both phase II proof-of-concept acute pain studies following abdominoplasty or bunionectomy surgery.
The results further highlight NaV1.8 as a new mechanism that could create an alternative to opioids for the treatment of pain. Vertex plans to advance VX-548 into pivotal development in acute pain in the second half following discussions with regulators.
Performance
Image Source: Zacks Investment Research
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 1.76% in the past five trading sessions. Among the biotech giants, Vertex has gained 6.19% during the period. Over the past six months, shares of Moderna have lost 48.87%. (See the last biotech stock roundup here: Biotech Stock Roundup: AXSM to Acquire JAZZ's Drug, IGMS Up on SNY Deal & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.