A proposal to buy out Soleno Therapeutics Inc. didn’t wait for European approval of Vykat XR (diazoxide choline) to treat hyperphagia in Prader-Willi syndrome, as Neurocrine Biosciences Inc. is putting on the table $53 per share in cash, which equates to an equity value of $2.9 billion.
After a phase III stumble, Acadia Pharmaceuticals Inc. will drop development of ACP-101, intranasal carbetocin, to treat hyperphagia in patients with the rare genetic disorder Prader-Willi syndrome. Top-line data from the 12-week, double-blind, randomized phase III study missed its primary endpoint by not producing a statistically significant improvement over placebo.
Soleno Therapeutics Inc. (NASDAQ: SLNO) pulled off in a major way its randomized-withdrawal phase III study with DCCR (diazoxide choline) in Prader-Willi syndrome, boosting the shares by $22.37, or 505%, to close Sept. 26 at $26.80. “Our work is not done, but this was a big step,” said CEO Anish Bhatnagar.
Not heeding earlier FDA advice has earned Levo Therapeutics Inc. a complete response letter (CRL) for its NDA seeking approval for intranasal carbetocin (LV-101) in hyperphagia associated with Prader-Willi syndrome (PWS). The CRL followed a 12-1 negative advisory committee vote in November.
Compelling testimony from parents who saw life-altering changes in their children who participated in Levo Therapeutics Inc.’s intranasal carbetocin clinical trial wasn’t enough to counter what the FDA’s Psychopharmacologic Drugs Advisory Committee saw as a lack of “substantial evidence” to support the drug’s effectiveness in treating hyperphagia associated with Prader-Willi syndrome (PWS).
