Following a substantial regulatory update, shares of Soleno Therapeutics, Inc. (NASDAQ: SLNO) are soaring on U.S. stock charts today. SLNO stock is trading 15.67% higher at $55.10 as of the last check during current session. Investor interest has been piqued by the company’s emphasis on treating Prader-Willi syndrome (PWS), which has improved stock performance.
FDA Review on DCCR Therapy for PWS
Soleno Therapeutics has received an update from the U.S. Food and Drug Administration (FDA) on rules pertaining to its New Drug Application (NDA) for extended-release DCCR (diazoxide choline) tablets. The FDA Review Division concluded that it might not be necessary to hold an advisory committee meeting at this time.
However, as the review process moves further, the review team will continue to determine whether or not a meeting of this kind is truly required. With a December 27, 2024, Prescription Drug User Fee Act, or PDUFA target action date, DCCR has been awarded Priority Review status for its investigation as a possible therapy for PWS, a rare genetic condition.
Effects of Prader-Willi syndrome on individuals
According to the Prader-Willi Syndrome Association USA, the condition affects one in every fifteen live births. Hyperphagia, a potentially deadly disorder characterized by intense hunger and an obsession with eating, is the primary symptom of the sickness.
In addition to behavioral issues, poor muscle tone, cognitive impairments, developmental delays, and co-morbidities including diabetes and cardiovascular disease, people with PWS also have various consequences. The discovery of DCCR is highly significant because there are currently no licensed medicines to address these incapacitating symptoms.
DCCR’s Promise in Treating PWS
DCCR is a novel, extended-release formulation of diazoxide choline, a compound previously used to treat various rare conditions, though not yet approved for PWS. Soleno (SLNO) has secured extensive patent protection for DCCR, which has demonstrated promising results in clinical trials.
In the Phase 3 clinical development program, DCCR showed efficacy in reducing hyperphagia and improving other symptoms such as aggressive behaviors and fat mass, offering hope to individuals living with PWS.