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It has been a low-key week for the biotech sector with few pipeline and regulatory updates. Acquisition news grabbed focus in the sector this week.
Recap of the Week’s Most Important Stories:
Zogenix Up on Acquisition News: Shares of Zogenix gained significantly following news of acquisition by UCB for approximately $1.9 billion. Both the companies announced that UCB would acquire Zogenix for 26.00 in cash and a contingent value right (CVR) for a potential cash payment of $2.00 upon EU approval of Fintepla as an orphan medicine for the treatment of Lennox-Gastaut syndrome (LGS) by Dec 31, 2023. The upfront consideration represents a 72% premium to Zogenix shares based on the 30-day volume-weighted average closing stock price of Zogenix prior to signing. Fintepla is already approved by the FDA and the European Medicines Agency (EMA) and is under regulatory review in Japan for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
Regeneron Application for Libtayo Label Expansion Accepted: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc). The sBLA is seeking approval for the drug in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC). The agency had set a target action date of Sep 19, 2022. A regulatory filing has also been recently submitted to the EMA. The sBLA is supported by results from a randomized, multicenter phase III study that evaluated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination) compared to platinum-doublet chemotherapy alone in the targeted population. The study was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone.
Regulatory Update From bluebird bio: bluebird bio (BLUE - Free Report) announced that the FDA has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) – for cerebral adrenoleukodystrophy (CALD). The regulatory body extended the PDUFA goal dates for beti-cel and eli-cel to get enough time to review additional clinical information previously submitted by the company in response to information requests by the FDA as part of its ongoing reviews. The information was deemed a major amendment. The new PDUFA action dates for bluebird’s lentiviral vector gene therapies are Aug 19, 2022, for beti-cel and Sep 16, 2022, for eli-cel. Shares were down in response to the news.
Gamida Gains on Update on Omidubicel BLA: Shares of Gamida Cell Ltd. gained after the company announced plans to initiate a rolling BLA submission for omidubicel. This follows receipt of positive Type B meeting correspondence from the FDA. The BLA will seek approval for omidubicel as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers.
Earlier, the regulatory body requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for phase III study. Gamida confirmed reaching an alignment with the FDA that the commercial-grade product and clinical-study product are analytically comparable. Following the establishment of the analytical comparability, the FDA agreed to the rolling submission of the BLA for omidubicel. Additional clinical data will not be required to initiate the BLA submission.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 6.15% in the past four trading sessions. Among the biotech giants, Vertex has gained 2.08% during the period. Over the past six months, shares of Vertex have soared 15.86%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB's AD Drug Update, AMGN's Drug Approval & Other Updates)
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
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Biotech Stock Roundup: ZGNX's Acquisition News, REGN, BLUE's Updates & More
It has been a low-key week for the biotech sector with few pipeline and regulatory updates. Acquisition news grabbed focus in the sector this week.
Recap of the Week’s Most Important Stories:
Zogenix Up on Acquisition News: Shares of Zogenix gained significantly following news of acquisition by UCB for approximately $1.9 billion. Both the companies announced that UCB would acquire Zogenix for 26.00 in cash and a contingent value right (CVR) for a potential cash payment of $2.00 upon EU approval of Fintepla as an orphan medicine for the treatment of Lennox-Gastaut syndrome (LGS) by Dec 31, 2023. The upfront consideration represents a 72% premium to Zogenix shares based on the 30-day volume-weighted average closing stock price of Zogenix prior to signing. Fintepla is already approved by the FDA and the European Medicines Agency (EMA) and is under regulatory review in Japan for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
Regeneron Application for Libtayo Label Expansion Accepted: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc). The sBLA is seeking approval for the drug in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC). The agency had set a target action date of Sep 19, 2022. A regulatory filing has also been recently submitted to the EMA. The sBLA is supported by results from a randomized, multicenter phase III study that evaluated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination) compared to platinum-doublet chemotherapy alone in the targeted population. The study was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone.
Regeneron currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Update From bluebird bio: bluebird bio (BLUE - Free Report) announced that the FDA has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) – for cerebral adrenoleukodystrophy (CALD). The regulatory body extended the PDUFA goal dates for beti-cel and eli-cel to get enough time to review additional clinical information previously submitted by the company in response to information requests by the FDA as part of its ongoing reviews. The information was deemed a major amendment. The new PDUFA action dates for bluebird’s lentiviral vector gene therapies are Aug 19, 2022, for beti-cel and Sep 16, 2022, for eli-cel. Shares were down in response to the news.
Gamida Gains on Update on Omidubicel BLA: Shares of Gamida Cell Ltd. gained after the company announced plans to initiate a rolling BLA submission for omidubicel. This follows receipt of positive Type B meeting correspondence from the FDA. The BLA will seek approval for omidubicel as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers.
Earlier, the regulatory body requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for phase III study. Gamida confirmed reaching an alignment with the FDA that the commercial-grade product and clinical-study product are analytically comparable. Following the establishment of the analytical comparability, the FDA agreed to the rolling submission of the BLA for omidubicel. Additional clinical data will not be required to initiate the BLA submission.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 6.15% in the past four trading sessions. Among the biotech giants, Vertex has gained 2.08% during the period. Over the past six months, shares of Vertex have soared 15.86%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB's AD Drug Update, AMGN's Drug Approval & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.