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Biotech Stock Roundup: GSK's Q4 Results, VRTX Gains on Update, TSVT Up on REGN Deal
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It was a busy week for the biotech sector, with news and updates from most bigwigs. Earnings from GSK plc (GSK - Free Report) and other pipeline and regulatory updates from 2seventy bio, Inc. (TSVT - Free Report) and Vertex (VRTX - Free Report) were in the spotlight.
Recap of the Week’s Most Important Stories:
GSK’s Q4 Earnings: GSK reported fourth-quarter 2023 adjusted earnings of 72 cents per American depositary share (ADS), missing the Zacks Consensus Estimate of 76 cents. Adjusted earnings rose 12% year over year on a reported basis and 25% at a constant exchange rate (CER).
Quarterly revenues increased 9% on a reported basis and 15% on a CER basis to $10.1 billion (£8.1 billion), beating the Zacks Consensus Estimate of $9.8 billion. The upside can be attributed to rising vaccine sales, which was partially offset by the declining COVID-19 product sales. The launch of the respiratory syncytial virus vaccine for older adults, Arexvy, boosted vaccine sales. The company expects sales to increase 5% to 7% in 2024.
Biogen to Discontinue Alzheimer’s Drug: Biogen (BIIB - Free Report) announced that it will discontinue the development and commercialization of Alzheimer’s disease (AD) drug Aduhelm. Consequently, the company terminated the post-marketing confirmatory ENVISION clinical study. The decision comes after Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for Aduhelm, as part of a focus on prioritizing the company’s portfolio.
Biogen incurred a one-time charge of approximately $60 million related to close-out costs for the program in the fourth quarter of 2023. Aducanumab was licensed from Neurimmune, and Biogen has now terminated that license. The rights to aducanumab will revert to Neurimmune.
Biogen will now focus on the advancement of its other AD drug, Leqembi, and accelerate the development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).
Vertex Up on Study Data: Vertex announced positive results from its phase III program on its investigational orally-administered non-opioid pain medicine, VX-548, to treat moderate-to-severe acute pain. Shares gained following the announcement. The phase 3 program included two randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study that enrolled patients with a broad range of surgical and non-surgical pain conditions.
The first two phase III studies achieved their primary endpoint — treatment with VX-548 showed a significant reduction in pain intensity across a 48-hour period compared with placebo. However, both studies failed to meet a key secondary goal of the superiority of VX-548 over the combination of opioid drug hydrocodone bitrate and acetaminophen in reducing pain.
Vertex also evaluated VX-548 for up to 14 days in a single-arm late-stage study across a broad range of other surgical and non-surgical acute pain conditions. Data from the study showed that around 83% of study participants rated the drug as ‘good, very good, or excellent’ in treating pain.
VX-548 was safe and well tolerated in all three studies. Based on the above data, management intends to submit a new drug application with the FDA for VX-548 across a broad label in moderate-to-severe acute pain by mid-2024.
2seventy bio Gains on Study Update: Shares of TSVT gained after the company announced a new strategic re-alignment of its ongoing business operations. As part of the re-alignment, the company entered into an asset purchase agreement (APA) with Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . Per this APA, Regeneron will acquire 2seventy bio’s oncology and autoimmune research and development pipeline and related platform technologies.
In exchange, 2seventy bio will receive an upfront payment of $5 million from Regeneron as well as milestone payment for the first approved product under this agreement and royalties on net sales of the same. Also, around 160 employees of 2seventy bio will be joining Regeneron as part of the APA. The transaction is expected to close in the first half of 2024, subject to certain customary closing conditions.
Importantly, as part of the strategic re-alignment, 2seventy bio will now exclusively focus on the commercialization and development of its BCMA-targeted CAR T therapy, Abecma (idecabtagene vicleucel). The therapy is approved for treating adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
2seventy bio expects annual cost savings of approximately $150 million in 2024 and $200 million in 2025, and the company’s cash runway is likely to extend beyond 2027.
Performance
The Nasdaq Biotechnology Index has lost 0.18% in the past five trading sessions. Among the biotech giants, Amgen has gained 2.87% during the period. Over the past six months, shares of Amgen have surged 36.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Down on Study Results, INBX Gains on Sanofi Deal & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.
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Biotech Stock Roundup: GSK's Q4 Results, VRTX Gains on Update, TSVT Up on REGN Deal
It was a busy week for the biotech sector, with news and updates from most bigwigs. Earnings from GSK plc (GSK - Free Report) and other pipeline and regulatory updates from 2seventy bio, Inc. (TSVT - Free Report) and Vertex (VRTX - Free Report) were in the spotlight.
Recap of the Week’s Most Important Stories:
GSK’s Q4 Earnings: GSK reported fourth-quarter 2023 adjusted earnings of 72 cents per American depositary share (ADS), missing the Zacks Consensus Estimate of 76 cents. Adjusted earnings rose 12% year over year on a reported basis and 25% at a constant exchange rate (CER).
Quarterly revenues increased 9% on a reported basis and 15% on a CER basis to $10.1 billion (£8.1 billion), beating the Zacks Consensus Estimate of $9.8 billion. The upside can be attributed to rising vaccine sales, which was partially offset by the declining COVID-19 product sales. The launch of the respiratory syncytial virus vaccine for older adults, Arexvy, boosted vaccine sales. The company expects sales to increase 5% to 7% in 2024.
GSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen to Discontinue Alzheimer’s Drug: Biogen (BIIB - Free Report) announced that it will discontinue the development and commercialization of Alzheimer’s disease (AD) drug Aduhelm. Consequently, the company terminated the post-marketing confirmatory ENVISION clinical study. The decision comes after Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for Aduhelm, as part of a focus on prioritizing the company’s portfolio.
Biogen incurred a one-time charge of approximately $60 million related to close-out costs for the program in the fourth quarter of 2023. Aducanumab was licensed from Neurimmune, and Biogen has now terminated that license. The rights to aducanumab will revert to Neurimmune.
Biogen will now focus on the advancement of its other AD drug, Leqembi, and accelerate the development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).
Vertex Up on Study Data: Vertex announced positive results from its phase III program on its investigational orally-administered non-opioid pain medicine, VX-548, to treat moderate-to-severe acute pain. Shares gained following the announcement. The phase 3 program included two randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study that enrolled patients with a broad range of surgical and non-surgical pain conditions.
The first two phase III studies achieved their primary endpoint — treatment with VX-548 showed a significant reduction in pain intensity across a 48-hour period compared with placebo. However, both studies failed to meet a key secondary goal of the superiority of VX-548 over the combination of opioid drug hydrocodone bitrate and acetaminophen in reducing pain.
Vertex also evaluated VX-548 for up to 14 days in a single-arm late-stage study across a broad range of other surgical and non-surgical acute pain conditions. Data from the study showed that around 83% of study participants rated the drug as ‘good, very good, or excellent’ in treating pain.
VX-548 was safe and well tolerated in all three studies. Based on the above data, management intends to submit a new drug application with the FDA for VX-548 across a broad label in moderate-to-severe acute pain by mid-2024.
2seventy bio Gains on Study Update: Shares of TSVT gained after the company announced a new strategic re-alignment of its ongoing business operations. As part of the re-alignment, the company entered into an asset purchase agreement (APA) with Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . Per this APA, Regeneron will acquire 2seventy bio’s oncology and autoimmune research and development pipeline and related platform technologies.
In exchange, 2seventy bio will receive an upfront payment of $5 million from Regeneron as well as milestone payment for the first approved product under this agreement and royalties on net sales of the same. Also, around 160 employees of 2seventy bio will be joining Regeneron as part of the APA. The transaction is expected to close in the first half of 2024, subject to certain customary closing conditions.
Importantly, as part of the strategic re-alignment, 2seventy bio will now exclusively focus on the commercialization and development of its BCMA-targeted CAR T therapy, Abecma (idecabtagene vicleucel). The therapy is approved for treating adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
2seventy bio expects annual cost savings of approximately $150 million in 2024 and $200 million in 2025, and the company’s cash runway is likely to extend beyond 2027.
Performance
The Nasdaq Biotechnology Index has lost 0.18% in the past five trading sessions. Among the biotech giants, Amgen has gained 2.87% during the period. Over the past six months, shares of Amgen have surged 36.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Down on Study Results, INBX Gains on Sanofi Deal & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.