SLNO - Soleno: Mid-2024 NDA Filing For PWS Treatment Is A Major Catalyst To Watch
2024-04-29 16:02:16 ET
Summary
- Soleno Therapeutics, Inc.'s New Drug Application filing of DCCR for the treatment of patients with Prader-Willi Syndrome expected by mid-2024.
- Ability to file NDA of DCCR for PWS was because of statistical significance achieved based on the primary endpoint of Study C602, which was the HQ-CT score.
- The global Prader-Willi Syndrome market in 2018 was estimated to be $2.11 billion in 2018.
- If DCCR is approved by the FDA for Prader-Willi Syndrome, it would be the first treatment of its kind to specifically target hyperphagia.
Soleno Therapeutics, Inc. ( SLNO ) is gearing up to file a New Drug Application [NDA] to the FDA of Diazoxide Choline [DCCR] for the treatment of patients with Prader-Willi Syndrome [PWS] in mid-2024. This is one major catalyst for investors to look forward to regarding this regulatory filing in the United States. Another important aspect to consider would be that even upon the FDA accepting this application of DCCR for review, it won't take long to complete it. That's because a recent development is that the company received Breakthrough Therapy Designation of this drug for the treatment of this patient population just today....
Soleno: Mid-2024 NDA Filing For PWS Treatment Is A Major Catalyst To Watch