Sangamo Therapeutics (SGMO) Advances Fabry Disease Therapy with FDA Rolling Submission

 

• Sangamo Therapeutics (SGMO, Financial) experiences a significant stock price increase following FDA's acceptance of its gene therapy submission.
• Despite promising developments, Sangamo faces financial challenges, including negative margins and declining revenue.

FDA Acceptance Boosts Sangamo Therapeutics

Sangamo Therapeutics (SGMO) saw its stock rise approximately 9% in premarket trading following the FDA's acceptance of a rolling submission for its ST-920 gene therapy targeting Fabry disease. This move comes after the FDA confirmed it would consider the estimated glomerular filtration rate (eGFR) slope as an endpoint for accelerated approval. Sangamo plans to initiate the Biologics License Application (BLA) process in Q4 2025. The company's Phase 1/2 STAAR study has already shown promising results for ST-920, also known as isaralgagene civaparvovec.

https://www.gurufocus.com/news/3220481/sangamo-therapeutics-sgmo-advances-fabry-disease-therapy-with-fda-rolling-submission