My quick take
Their pivotal trial failed to meet its primary endpoint because the most recent data shows DCCR tablets are most effective in those with severe hyperphagia ( insatiable hunger ) ...so if U enroll to many with low to moderate hyperphagia it would obviously be harder to get the stat sig results U need .
Think of the R-IT trial being run with mostly primary prevention instead of the 70% secondary prevention patients actually used.
So this final short trial ...80 patients over 4 mths I'm sure they will try and recruit the most severe patients ....and may only get approval for this subset
The patent issue. Diazoxide is an oral suspension that apparently tasted horrible . DCCR are extended release tablets and apparently far more effective. In the Prader Willi population those with severe hyperphagia are often institutionalized ( group homes ) ....and care givers will want the best drug available to help control the often aggressive behaviors associated with this condition. Also the drug they can get these ( mostly kids / teenagers ) to take daily for at least a yr .
So Amarins Vascepa brand vs generic is not the best comparison .
Agree its very speculative ...but the FDA is under pressure from PW families to approve something for this condition ( currently theres no FDA approved drugs for PW ) ...and the severe hyperphagia indication with DCCR looks to be the best near term hope .
Short trial ...80 patients for 4 mths once fully enrolled.
Once fully enrolled the Co get $10m from the investors with additional payments on trial success etc
Kiwi
Recent SLNO News
- Soleno Therapeutics Announces Oral Presentation featuring DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome at ENDO 2024 • GlobeNewswire Inc. • 05/22/2024 08:05:00 PM
- Soleno Therapeutics to Participate in Upcoming Investor Conferences • GlobeNewswire Inc. • 05/22/2024 12:00:00 PM
- Soleno Therapeutics Stands with the Prader-Willi Syndrome Community • GlobeNewswire Inc. • 05/15/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:31:17 PM
- Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/09/2024 08:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 09:28:56 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 05/06/2024 08:58:44 PM
- Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock • GlobeNewswire Inc. • 05/03/2024 02:32:12 AM
- Soleno Therapeutics Announces Proposed Public Offering of Common Stock • GlobeNewswire Inc. • 05/02/2024 08:01:37 PM
- Soleno Therapeutics Announces Peer-Reviewed Publication of Data Comparing DCCR Treatment to the Natural History of Prader-Willi Syndrome • GlobeNewswire Inc. • 04/30/2024 12:00:00 PM
- Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS) • GlobeNewswire Inc. • 04/29/2024 12:00:00 PM
- Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 04/19/2024 08:05:00 PM
- Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 03/08/2024 09:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:06:32 AM
- Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results • GlobeNewswire Inc. • 03/06/2024 09:05:00 PM
- Soleno Therapeutics to Present at the TD Cowen 44th Annual Health Care Conference • GlobeNewswire Inc. • 02/22/2024 01:00:00 PM
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- Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 01/29/2024 09:05:00 PM
- Soleno Therapeutics Strengthens Leadership Team with Key Appointments • GlobeNewswire Inc. • 01/24/2024 01:00:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 01/17/2024 09:06:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/08/2024 10:37:17 PM
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