The NDA for the formerly named Nyxol is now an open and shut case for Ocuphire Pharma Inc. and Viatris Inc. The U.S. FDA has approved Ryzumvi (phentolamine ophthalmic solution) for treating pharmacologically induced mydriasis, better known as dilating the pupil. Ryzumvi, a small-molecule eye drop, reduces the pupil’s diameter after it is dilated with adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide. The treatment reduces pupil size by acting on the iris dilator muscle.
Positive top-line phase III study results for olezarsen in treating familial chylomicronemia syndrome has Ionis Pharmaceuticals Inc. looking down the road to U.S. FDA approval. It’s the company’s second attempt at getting an approval for treating the rare disorder.
Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication.
Fearing cross contamination might have occurred during manufacturing, Scynexis Inc. is recalling Brexafemme (ibrexafungerp tablets) from the market and putting a temporary hold on the drug’s clinical trials until it knows more details.
Abpro Corp. is making another attempt to go public, this time by merging with Atlantic Coastal Acquisition Corp. II. The merger would put Abpro’s company value at $725 million. Atlantic Coastal is a special purpose acquisition company (SPAC) that went public in January 2022. Its stock (NASDAQ:ACAB) closed Sept. 22 at $10.63 per share.
Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication.
Merck KGaA has entered deals that could bring U.K. artificial intelligence companies Benevolentai Ltd. and Exscientia plc more than $1.2 billion. Oxford, U.K.-based Exscientia and Merck will collaborate to find three small-molecule candidates in oncology, neuroinflammation and immunology. Exscientia is getting $20 million up front and could bring in $674 million in milestones payments.
Airna Corp. Inc. has launched through a $30 million financing to develop a pipeline of RNA editing therapeutics for treating rare diseases and prevalent diseases. It’s a wide spectrum of diseases made potentially more easily treatable because of the relatively recent revolution in RNA editing.
Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human monoclonal antibody targeting factor XI/XIa reduced bleeding when compared to a leading standard of care, direct oral anticoagulant, Xarelto (rivaroxaban, Johnson & Johnson).
In the daunting shadow of previous years’ numbers, two companies jumped into this year’s relatively tepid IPO market. Rayzebio Inc. priced its upsized $311 million IPO of 17.2 million shares at $18 each. Gross proceeds of about $290.1 million are expected by the radiopharmaceutical cancer therapy developer. On Sept. 15, shares (NASDAQ:RYZB) closed up 33.3% at $24 each. Also, Neumora Therapeutics Inc. priced its IPO of 14.7 million shares at $17 each, looking for gross proceeds of about $250 million. The company, which is developing seven products targeting brain diseases, saw shares (NASDAQ:NMRA) close 4.4% downward at $16.25 on Sept. 15.
