Soleno Therapeutics' Study Outcome Bolsters Confidence In PWS Treatment

Earlier on Tuesday, Soleno Therapeutics Inc SLNO released top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for Prader-Willi syndrome (PWS).

Cantor Fitzgerald raised the price target on Soleno Therapeutics from $19 to $35, with an Overweight rating.

The analysts Kristen Kluska, Richard Miller, and Jason Bouvier note that the trial outcome is as good as could have been expected.

The analysts say the data suggests promising signals regarding the treatment's durability.

The analyst suggests that the Prader-Willi Syndrome (PWS) market could hold significant appeal for Soleno Therapeutics. PWS is a rare condition, but patients typically receive early diagnoses. 

Additionally, considerable awareness of this drug exists within the patient and family communities, indicating a favorable environment for a potential first-to-market opportunity.

Cantor also writes that throughout the trial, the efficacy curves for the placebo and the drug consistently diverged early, never crossed paths, and exhibited increasing separation over time.

Cantor writes that the outcome opens the door to a potential New Drug Application filing, which could support a potential approval, marking the first FDA-approved drug for PWS.

The analysts still believe the Soleno Therapeutics stock remains undervalued as it is trading at roughly 1x 2029E revenue, and they model 2035E revenues of ~$1 billion.

Price Action: SLNO shares are up 507.8% at $26.75 on the last check Tuesday.

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