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

14 Jun 2022

• 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...

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