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Biotech Stock Roundup: BMYs Opdivo Gets FDA Nod for Gastric Cancer & Other Updates
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The biotech sector continues to be in focus with pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Bristol Myers’ Opdivo Wins FDA Nod for Another Indication: Bristol Myers Squibb (BMY - Free Report) announced that its blockbuster immuno-oncology drug, Opdivo (nivolumab), has been approved for another indication in the United States. The drug has been approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.
The approval was based on encouraging results from the phase III CheckMate -649 study, evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) compared to chemotherapy (mFOLFOX6 or CapeOX) alone.
Bristol Myers also announced encouraging results from the CheckMate -816 study on Opdivo (nivolumab) for the treatment of non-small cell lung cancer (NSCLC). CheckMate -816 is a phase III randomized, open-label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.
Results from the study showed that neoadjuvant treatment with three cycles of Opdivo plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa NSCLC.
Anixa Down on Regulatory Update for CAR T Therapy: Shares of Anixa Biosciences (ANIX - Free Report) were down after the FDA requested additional information regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T). The therapy is being developed in partnership with Moffitt Cancer Center (MCC). A clinical hold has been placed on the study by the regulatory body, pending the submission of additional information requested by the FDA.
The FDA will write a letter to MCC in the next 30 days with detailed and specific information requested. MCC will assemble and submit information addressing the request as soon as possible thereafter.
Vertex Amends Collaboration With CRISPR Therapeutics: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) amended its collaboration agreement with CRISPR Therapeutics (CRSP - Free Report) to develop, manufacture and commercialize CTX001, an investigational CRISPR/Cas9-based gene editing therapy being developed as a potentially curative therapy for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT).
Under terms of the amended agreement, Vertex will lead the worldwide development, manufacturing and commercialization of CTX001. The revised agreement provides Vertex with 60% and CRISPR with 40% of program economics. CRISPR will earn a $900-million upfront payment with potential for an additional $200-million milestone payment upon approval of CTX001.
Incyte, MorphoSys Begin Dosing in Lymphoma Study: Incyte (INCY - Free Report) and partner MorphoSys AG announced that the first patient has been dosed in the late-stage inMIND study on tafasitamab. The phase III study is evaluating the efficacy and safety of tafasitamab or placebo in combination with Revlimid (lenalidomide) and Rituxan in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study is expected to enroll more than 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 1.76% in the last five trading sessions. Among the biotech giants, Alexion gained 8.33% during the period. Over the past six months, shares of Alexion have surged 34.31%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD's UC Drug Approval, REGN's COVID-19 Antibody Data & More).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Biotech Stock Roundup: BMYs Opdivo Gets FDA Nod for Gastric Cancer & Other Updates
The biotech sector continues to be in focus with pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Bristol Myers’ Opdivo Wins FDA Nod for Another Indication: Bristol Myers Squibb (BMY - Free Report) announced that its blockbuster immuno-oncology drug, Opdivo (nivolumab), has been approved for another indication in the United States. The drug has been approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.
The approval was based on encouraging results from the phase III CheckMate -649 study, evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) compared to chemotherapy (mFOLFOX6 or CapeOX) alone.
Bristol Myers also announced encouraging results from the CheckMate -816 study on Opdivo (nivolumab) for the treatment of non-small cell lung cancer (NSCLC). CheckMate -816 is a phase III randomized, open-label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.
Results from the study showed that neoadjuvant treatment with three cycles of Opdivo plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa NSCLC.
Anixa Down on Regulatory Update for CAR T Therapy: Shares of Anixa Biosciences (ANIX - Free Report) were down after the FDA requested additional information regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T). The therapy is being developed in partnership with Moffitt Cancer Center (MCC). A clinical hold has been placed on the study by the regulatory body, pending the submission of additional information requested by the FDA.
The FDA will write a letter to MCC in the next 30 days with detailed and specific information requested. MCC will assemble and submit information addressing the request as soon as possible thereafter.
Anixa currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Amends Collaboration With CRISPR Therapeutics: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) amended its collaboration agreement with CRISPR Therapeutics (CRSP - Free Report) to develop, manufacture and commercialize CTX001, an investigational CRISPR/Cas9-based gene editing therapy being developed as a potentially curative therapy for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT).
Under terms of the amended agreement, Vertex will lead the worldwide development, manufacturing and commercialization of CTX001. The revised agreement provides Vertex with 60% and CRISPR with 40% of program economics. CRISPR will earn a $900-million upfront payment with potential for an additional $200-million milestone payment upon approval of CTX001.
Incyte, MorphoSys Begin Dosing in Lymphoma Study: Incyte (INCY - Free Report) and partner MorphoSys AG announced that the first patient has been dosed in the late-stage inMIND study on tafasitamab. The phase III study is evaluating the efficacy and safety of tafasitamab or placebo in combination with Revlimid (lenalidomide) and Rituxan in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study is expected to enroll more than 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 1.76% in the last five trading sessions. Among the biotech giants, Alexion gained 8.33% during the period. Over the past six months, shares of Alexion have surged 34.31%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD's UC Drug Approval, REGN's COVID-19 Antibody Data & More).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2021 today >>