2024-05-10 11:19:15 ET
- Baird has initiated Solerno Therapeutics ( NASDAQ: SLNO ) with a buy rating saying that they view U.S. approval of the company company's lead asset, an extended-release formulation of diazoxide choline (DCCR) for a condition associated with Prader-Willi syndrome as likely.
- The firm has a $70 price target (~51% upside based on May 9 close).
- Analyst Brian Skorney said that "we think that the totality of evidence more than favors a nod from an FDA that has been increasingly flexible with applications in orphan diseases where there are no approved therapies."
- He sees an 80% chance of approval by 2025.
- DCCR is under investigation for hyperphagia associated with Prader-Willi syndrome. Hyperphagia is extreme hungers and the syndrome is characterized by obesity, intellectual disability, and shortness in height.
- Skorney noted that a randomized withdrawal study (C602) demonstrated evidence of efficacy, with a 13-week double-blind study and natural history comparison as additional evidence.
- "Although not a standard approach, we believe the very significant unmet need and compelling evidence of effect will suffice for an approval," he wrote.
- Skorney added that DCCR could bring in more than $800M in sales in the U.S., and that is just with 40% penetration. On a global scale, it could earn $1B.
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Solerno a new outperform at Baird on lead candidate for Prader-Willi syndrome