FDA Agrees to Accelerated Approval Endpoint for Sangamo's ST-920; Key BLA Modules Submitted
Summary
Sangamo Therapeutics has significantly advanced its rolling Biologics License Application (BLA) submission for ST-920, its investigational gene therapy for Fabry disease, by submitting the preclinical and clinical modules to the FDA. This development is highly material as the FDA has also agreed to accept the mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks as an endpoint to support an accelerated approval pathway. For a company of Sangamo's size, this regulatory progress for a wholly-owned asset represents a substantial de-risking event and could significantly expedite ST-920's path to market. Traders will closely monitor the FDA's review process and anticipate further updates on the BLA, including potential PDUFA dates.
At the time of this announcement, SGMO was trading at $0.38 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $140.3M. The 52-week trading range was $0.35 to $1.06. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.