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It was a regular week for the biotech sector with quite a few important pipeline and regulatory updates. Among these, Cassava Sciences, Inc. SAVA and Lexeo Therapeutics LXEO were down on leadership changes and study results, respectively.
Recap of the Week’s Most Important Stories:
SAVA Down on CEO Resignation: Cassava Sciences announced that Remi Barbier, the company’s chairman, president and CEO, has resigned from his positions. Consequently, the board has appointed Richard Barry as SAVA’s executive chairman and principal executive officer, with immediate effect. Cassava is looking for a permanent CEO and will separate the roles of its chairman and CEO. In addition, Lindsay Burns, Ph.D., SVP, Neuroscience, is also leaving the company. Shares of SAVA were down 29% following the news.
The company stated that its priority remains on developing a potentially effective treatment for Alzheimer’s disease and it will do so with transparency, accountability and the highest ethical business practices. SAVA also stated that the ongoing phase III trials are being run according to FDA protocols, and no one from the company knows or will ever know the subjects receiving a drug or placebo. No individual has access to sub-study results and other information that might be used to infer which patients are on placebo.
Blinding information is and will be held exclusively by a small group of professionals at SAVA’s CRO, Premier Research. Statistical analyses for these studies will be conducted by professional biostatisticians at Pentara Corporation.
Regulatory Update From Lexicon: Lexicon Pharmaceuticals LXRX announced that the FDA has accepted its resubmitted new drug application (NDA) seeking approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease. A final decision is expected by Dec 20, 2024. If approved, the product will be marketed under the brand name Zynquista, with a commercial launch expected in early 2025. The company’s shares rose on the news.
Lexicon had initially submitted an NDA in 2018 for sotagliflozin in T1D indication. However, the FDA issued a complete response letter (CRL) to the NDA in 2019 after one of its advisory committees issued a split opinion regarding its approval. Management stated that the agency considers the resubmission as a complete response to this CRL.
Lexicon currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Update From Kyverna: Kyverna Therapeutics, Inc. KYTX announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its lead pipeline candidate KYV-101. It did so for the treatment of patients suffering from refractory stiff-person syndrome (SPS).