![]() ![]() ( AMLX Quick Quote AMLX - Free Report) 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. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Īmylyx Up on Update: Shares of Amylyx Pharmaceuticals, Inc. Syros currently has a Zacks Rank #2 (Buy). 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. The combined company will operate as Syros Pharmaceuticals and continue to advance Syros’ ongoing clinical programs. 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. surged following the news of its acquisition by Syros Pharmaceuticals ( SYRS Quick Quote SYRS - Free Report). Syros to Acquire TYME Technologies: Shares of TYME Technologies, Inc. The EC granted CMA for Nuvaxovid to prevent COVID-19 in individuals aged 18 and more in December 2021. 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 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. 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. Novavax COVID-19 Vaccine Update: Novavax ( NVAX Quick Quote NVAX - Free Report) 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. Tyme stocktwits trial#The trial will now be reopened for screening, enrollment and dosing at multiple sites in the United States. The study was placed on clinical hold by the FDA based on its determination of insufficient information for dose escalation with the product. The study was for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycaemia. VX-880 is a stem cell-derived, fully differentiated islet replacement therapy used in combination with standard immunosuppression to protect the implanted cells. Tyme stocktwits update#Regulatory Update From Vertex: Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) announced that the FDA has lifted the clinical hold placed on the phase I/II study of experimental candidate VX-880. Recap of the Week’s Most Important Stories: Acquisitions and collaborations have also taken center stage in this space. The biotech sector has been in the spotlight in the past week with important pipeline and regulatory updates. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |