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Soleno Bounces Back With New Prader-Willi Data After Regulatory Setbacks

 
• By Ayisha Sharma

The US biotech has released new positive data from two late-stage studies in the rare disease after the US FDA asked for more controlled data following an initial disappointment.    

Hyperphagia Make Patients Feel Constantly Hungry • Source: Shutterstock

Soleno Therapeutics, Inc. has unveiled promising data from two Phase III studies of its Prader-Willi syndrome candidate a year after regulators were left dissatisfied with pivotal data that were limited by pandemic-related disruptions.

Last year, the US Food and Drug Administration demanded another controlled trial of diazoxide choline extended-release (DCCR) in Prader-Willi syndrome (PWS) following data analyses submitted from the pivotal DESTINY PWS trial, also known as C601. (Also see "Soleno Shaken By FDA Demand For Second DCCR Phase III Trial In PWS" - Scrip, 9 March, 2021

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.