Yahoo Finance Biotech Stock Roundup: VRTX's Regulatory Update, TYME Gains on Acquisition & More
The biotech sector has been in the spotlight in the past week with important pipeline and regulatory updates. Acquisitions and collaborations have also taken center stage in this space.
Recap of the Week’s Most Important Stories:
Regulatory Update From Vertex: Vertex Pharmaceuticals VRTX announced that the FDA has lifted the clinical hold placed on the phase I/II study of experimental candidate VX-880. VX-880 is a stem cell-derived, fully differentiated islet replacement therapy used in combination with standard immunosuppression to protect the implanted cells. The study was for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycaemia. The study was placed on clinical hold by the FDA based on its determination of insufficient information for dose escalation with the product. The trial will now be reopened for screening, enrollment and dosing at multiple sites in the United States.
Novavax COVID-19 Vaccine Update: Novavax NVAX announced that the European Commission (“EC”) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) vaccine in the European Union for adolescents aged 12 through 17 for COVID-19. An approval was in the cards as the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive recommendation for the same. The authorization was based on data from the ongoing pediatric expansion of the phase III study, PREVENT- 19, among 2,247 adolescents aged 12 through 17 years across 73 sites in the United States, to evaluate the safety, effectiveness (immunogenicity) and efficacy of Nuvaxovid. Data showed Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States. The EC granted CMA for Nuvaxovid to prevent COVID-19 in individuals aged 18 and more in December 2021.
Syros to Acquire TYME Technologies: Shares of TYME Technologies, Inc. TYME surged following the news of its acquisition by Syros Pharmaceuticals SYRS. Per the terms, Syros will acquire TYME, including its pipeline assets and net cash at closing, which after accounting for wind-down and transaction expenses, is currently estimated to be approximately $60 million. The combined company will operate as Syros Pharmaceuticals and continue to advance Syros’ ongoing clinical programs. Following the closing of the merger, the total cash balance of the combined company is expected to be approximately $240 million, sufficient to fund Syros’ planned operating expenses and capital expenditure requirements into 2025.
Syros currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Amylyx Up on Update: Shares of Amylyx Pharmaceuticals, Inc. AMLX gained after the FDA informed the company that the agency is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) to discuss the new drug application (NDA) for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS) on Sep 7, 2022. AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union.
The regulatory body will formally announce the scheduling of the planned PCNSDAC meeting in the Federal Register. Discussions will focus on the additional analyses of data from the clinical studies that were determined by the FDA to constitute a major amendment to the NDA. The target action date for the NDA is Sep 29, 2022, which was extended from Jun 29, 2022, to allow more time for the FDA to review additional analyses of data from more clinical studies.
Performance
The Nasdaq Biotechnology Index has gained 4.36% in the past four trading sessions. Among the biotech giants, Moderna has gained 9.39% during the period. Over the past six months, shares of Vertex have gained 30.47%. (See the last biotech stock roundup here: Biotech Stock Roundup: EPZM Soars on IPSEY Offer, KZR Up on Study Data & More)
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
Novavax, Inc. (NVAX) : Free Stock Analysis Report
Syros Pharmaceuticals, Inc. (SYRS) : Free Stock Analysis Report
Amylyx Pharmaceuticals, Inc. (AMLX) : Free Stock Analysis Report
Tyme Technologies, Inc. (TYME) : Free Stock Analysis Report
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