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Biotech Stock Roundup: BMY, TSVT Down on Setback, TRDA, MOR Offer Updates
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The focus is back on regular drug approvals and other pipeline and regulatory updates in the biotech sector. While nothing significant came from bigwigs, quite a few other companies came out with important updates on their key candidates.
Recap of the Week’s Most Important Stories:
Bristol Myers, TSVT Down on Update: Bristol Myers Squibb (BMY) and partner 2seventy bio, Inc. (TSVT - Free Report) faced a setback when the FDA informed the companies that the regulatory body would not be able to give a decision on the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) by the original target date of Dec 16, 2023. Shares of both companies were down on the news.
The sBLA is seeking approval of Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the phase III KarMMa-3 study. Both companies also announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) will meet to review data supporting the sBLA for Abecma. However, the FDA has not yet confirmed the date of the ODAC meeting.
Abecma is a CAR T cell therapy indicated for adult patients with triple-class exposed RRMM after four or more prior lines of therapy. BMY and TSVT are jointly developing and commercializing Abecma in the United States. Both companies anticipate that the committee will review data related to the secondary endpoint of overall survival. Bristol Myers Squibb and 2seventy bio also plan to discuss with the FDA and participate in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment.
Entrada Slumps on Update: Shares of clinical-stage biopharmaceutical company, Entrada Therapeutics, Inc. (TRDA - Free Report) , slumped after the company announced that the FDA declined to lift the clinical placed on the investigational new drug (IND) application for the phase 1 clinical trial of ENTR-601-44. The company stated that the FDA’s refusal comes despite the company providing additional information to the FDA. ENTR-601-44 is the lead product candidate within Entrada’s Duchenne muscular dystrophy franchise from its growing pipeline of EEV-therapeutics.
Concurrently, it announced the completion of dosing for the first and second cohorts of its phase I study, ENTR-601-44-101. Entrada plans to disclose data from this study in the second half of 2024. The study is being conducted in the United Kingdom to evaluate the safety and tolerability of a single dose of ENTR-601-44 in healthy male volunteers, with a target enrollment of approximately 40 participants. The trial will also evaluate pharmacokinetics and target engagement, as measured by exon skipping in skeletal muscle.
MorphoSys Down on Study Update: MorphoSys AG (MOR - Free Report) announced top-line results from the late-stage MANIFEST-2 study evaluating pelabresib plus Jakafi (ruxolitinib) in JAK inhibitor-naïve patients with myelofibrosis.
This phase III study met its primary endpoint of at least a 35% or greater reduction in spleen volume (SVR35) following 24 weeks of treatment with pelabresib/Jakafi combination. Data from the study showed that 66% of patients who were administered the combination achieved SVR35 compared with 35% of those participants who received a placebo plus Jakafi. However, the study did not meet its key secondary endpoints assessing symptom improvement — at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) at week 24.
Though the results showed a strong positive trend favoring the pelabresib/Jakafi combination, the results were in close proximity to those treated in the placebo group. Data from the study showed that only 52% of patients who received pelabresib/Jakafi combination achieved the TSS50 endpoint compared with 46% of study participants who received placebo plus Jakafi. Investors were disappointed with the mixed data.
Performance
The Nasdaq Biotechnology Index has gained 0.39% in the past five trading sessions. Among the biotech giants, BMY has lost 4.17% during the period. Over the past six months, shares of Moderna have plunged 38.32%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMYs Drug Approval, VRTX CRSP Gene Therapy Gets MHRA Nod).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: BMY, TSVT Down on Setback, TRDA, MOR Offer Updates
The focus is back on regular drug approvals and other pipeline and regulatory updates in the biotech sector. While nothing significant came from bigwigs, quite a few other companies came out with important updates on their key candidates.
Recap of the Week’s Most Important Stories:
Bristol Myers, TSVT Down on Update: Bristol Myers Squibb (BMY) and partner 2seventy bio, Inc. (TSVT - Free Report) faced a setback when the FDA informed the companies that the regulatory body would not be able to give a decision on the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) by the original target date of Dec 16, 2023. Shares of both companies were down on the news.
The sBLA is seeking approval of Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the phase III KarMMa-3 study. Both companies also announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) will meet to review data supporting the sBLA for Abecma. However, the FDA has not yet confirmed the date of the ODAC meeting.
Abecma is a CAR T cell therapy indicated for adult patients with triple-class exposed RRMM after four or more prior lines of therapy. BMY and TSVT are jointly developing and commercializing Abecma in the United States. Both companies anticipate that the committee will review data related to the secondary endpoint of overall survival. Bristol Myers Squibb and 2seventy bio also plan to discuss with the FDA and participate in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment.
BMY currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Entrada Slumps on Update: Shares of clinical-stage biopharmaceutical company, Entrada Therapeutics, Inc. (TRDA - Free Report) , slumped after the company announced that the FDA declined to lift the clinical placed on the investigational new drug (IND) application for the phase 1 clinical trial of ENTR-601-44. The company stated that the FDA’s refusal comes despite the company providing additional information to the FDA. ENTR-601-44 is the lead product candidate within Entrada’s Duchenne muscular dystrophy franchise from its growing pipeline of EEV-therapeutics.
Concurrently, it announced the completion of dosing for the first and second cohorts of its phase I study, ENTR-601-44-101. Entrada plans to disclose data from this study in the second half of 2024. The study is being conducted in the United Kingdom to evaluate the safety and tolerability of a single dose of ENTR-601-44 in healthy male volunteers, with a target enrollment of approximately 40 participants. The trial will also evaluate pharmacokinetics and target engagement, as measured by exon skipping in skeletal muscle.
MorphoSys Down on Study Update: MorphoSys AG (MOR - Free Report) announced top-line results from the late-stage MANIFEST-2 study evaluating pelabresib plus Jakafi (ruxolitinib) in JAK inhibitor-naïve patients with myelofibrosis.
This phase III study met its primary endpoint of at least a 35% or greater reduction in spleen volume (SVR35) following 24 weeks of treatment with pelabresib/Jakafi combination. Data from the study showed that 66% of patients who were administered the combination achieved SVR35 compared with 35% of those participants who received a placebo plus Jakafi. However, the study did not meet its key secondary endpoints assessing symptom improvement — at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) at week 24.
Though the results showed a strong positive trend favoring the pelabresib/Jakafi combination, the results were in close proximity to those treated in the placebo group. Data from the study showed that only 52% of patients who received pelabresib/Jakafi combination achieved the TSS50 endpoint compared with 46% of study participants who received placebo plus Jakafi. Investors were disappointed with the mixed data.
Performance
The Nasdaq Biotechnology Index has gained 0.39% in the past five trading sessions. Among the biotech giants, BMY has lost 4.17% during the period. Over the past six months, shares of Moderna have plunged 38.32%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMYs Drug Approval, VRTX CRSP Gene Therapy Gets MHRA Nod).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.