SLNO Stock Rises on Upbeat Regulatory Update on PWS Drug NDA

Company Overview - Soleno Therapeutics (SLNO) shares increased by 9.1% on Tuesday and an additional 4.1% in after-market trading following a positive regulatory update regarding its new drug application (NDA) for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) [1] - The FDA's Review Division indicated that an advisory committee meeting is not currently necessary for the DCCR NDA, although the need for one may be reassessed during the review process [2] Product Details - DCCR is a proprietary, once-daily extended-release formulation containing diazoxide choline, which is not yet approved for PWS but is used for treating certain rare diseases [3] - The NDA for DCCR is under the FDA's Priority Review pathway, which shortens the review period to four months, with a final decision expected by December 27, 2024 [3] Market Context - Approximately one in every 15,000 newborns is affected by PWS, with hyperphagia being the most common symptom, leading to serious long-term health issues [5] - There are currently no approved treatments addressing hyperphagia or other aspects of PWS, highlighting a significant unmet medical need [6] Competitive Landscape - Acadia Pharmaceuticals has introduced a new candidate, carbetocin nasal spray, for treating hyperphagia associated with PWS, which was acquired through the purchase of Levo Therapeutics [6] - A previous study indicated that carbetocin showed a statistically significant reduction in hyperphagia-related behaviors, leading to the initiation of a pivotal phase III study by Acadia in late 2023 [7] Regulatory Designations - Soleno has secured extensive patent protection for the use of diazoxide, diazoxide choline, and DCCR in PWS patients, with DCCR receiving Breakthrough, Fast Track, and Orphan Drug designations from the FDA [4]