CALT - FDA action dates catalysts and other events for pharma/biotech in September
With Labor Day marking the unofficial end of summer, September looks to be a busy month for events impacting pharmaceutical and biotechnology companies. Here's a look at what events to look forward to this month that could impact pharma and biotech stocks. Sept. 3: FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting on toxicity risks of AAV vector-based gene therapy products. Sept. 3: The FDA is set to act on an sBLA from Merck (MRK +0.7%) and Eisai (OTCPK:ESALY -1.0%) for the combination of Keytruda (pembrolizumab) and Lenzima (lenvatinib) for advanced endometrial carcinoma. Sept. 15: The FDA action date for Calliditas Therapeutics AB's (CALT +5.7%) Nefecon (NeflgArd) for IgA nephropathy. The NDA has Priority Review status. Sept. 17: FDA Vaccines and Related Biological Products Advisory Committee meets to discuss booster dose of Pfizer (PFE +0.7%)/BioNTech's (NASDAQ:BNTX) COVID-19 vaccine. Sept. 17: FDA Pediatric Advisory Committee meets to discuss the FLOURISH Pediatric
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FDA action dates, catalysts, and other events for pharma/biotech in September