Scholar Rock (NASDAQ:SRRK) said the U.S. Food and Drug Administration has accepted for review its resubmitted Biologics License Application for apitegromab, the company’s investigational treatment for ...

The FDA has accepted Scholar Rock's application for regulatory approval of apitegromab for SMA and is expected to have its ...

"I am very pleased to announce that the FDA has accepted for review our biologics license application for apitegromab for the treatment of children and adults living with SMA." (CEO & Chairman David ...

Thank you, Laura, and good morning. Scholar Rock is positioned for a pivotal year ahead. To that end, today, I am very pleased to announce that the FDA has accepted for review our biologics license ...

FDA review date: The FDA set a September 30, 2026 PDUFA date for apitegromab's approval decision for SMA treatment. Dual facility strategy: Scholar Rock's accepted BLA includes two U.S. fill-finish ...

Apitegromab met the primary endpoint in the SAPPHIRE trial, showing significant motor function improvement in SMA patients compared to placebo. Scholar Rock plans to submit a biologics license ...

A Prescription Drug User Fee Act target date of September 22, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic ...

Please provide your email address to receive an email when new articles are posted on . The study included 58 individuals with SMA types 2 and 3 who were treated with IV apitegromab for 52 weeks. At ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. 30.4% of patients who received apitegromab had a 3-point ...

Scholar Rock Holding Corporation (NASDAQ:SRRK) President & CEO Jay Backstrom presented at the J.P. Morgan Healthcare Conference. The discussions mainly focused on apitegromab for spinal muscular ...

The least-squares mean difference in the Hammersmith Functional Motor Scale-Expanded change from baseline at 12 months was 1.8 points for those 2 to 12 years receiving apitegromab vs placebo.