Scattered investor qualms about Nuvalent Inc.’s largely upbeat data during the European Society for Medical Oncology (ESMO) meeting in Barcelona didn’t stop the firm from pricing an upsized $500 million public offering. The Cambridge, Mass.-based firm is selling 5 million shares of class A common stock at $100 each. The offering is expected to close on Sept. 18, with underwriters holding a 30-day option to purchase up to 750,000 more shares.
Immuneering Corp. CEO Benjamin Zeskind said he is “pleased with enrollment across the full trial” that’s ongoing with IMM-1-104 in cancer, and 30 subjects are due per arm in five arms that the phase IIa experiment includes.
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
After missing the primary and secondary endpoints in its phase III study of losmapimod in treating the rare disease facioscapulohumeral muscular dystrophy (FHSD), Fulcrum Therapeutics Inc. is yanking the program’s plug. The selective p38α/β mitogen activated protein kinase inhibitor had a lot of money behind it. It was originally in-licensed from GSK plc and then, in May, Sanofi SA signed on to help Fulcrum develop and commercialize losmapimod for FHSD worldwide, excluding the U.S., in a deal worth $1.06 billion.
Silo Pharma Inc. has completed a pre-IND meeting with the FDA regarding the company’s development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.
Stealth Biotherapeutics Inc. has been awarded the Kyle Bryant Translational Research Award from the Friedreich’s Ataxia Research Alliance (FARA) to evaluate mitochondria-targeted molecule SBT-589 in Friedreich’s ataxia (FA).
Gilead Sciences Inc. and Genesis Therapeutics Inc. have entered into a strategic collaboration to discover and develop novel small-molecule therapies across multiple targets.
Researchers from Japan Tobacco Inc. presented the discovery and preclinical characterization of novel highly potent Keap1-Nrf2 protein-protein interaction (PPI) inhibitors.
Neuroinflammation underlies neurodegeneration in Alzheimer’s disease (AD) and other brain disorders. The stimulation of nicotinic α7 receptors, involved in the regulation of neuroinflammation, has shown efficacy in improving memory and learning in AD models.
Friday the 13th could be a make-or-break day in the U.S. for Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid). That’s the day the company will make its case before the FDA’s Gastrointestinal Drugs Advisory Committee for turning an 8-year-old accelerated approval into traditional approval.
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