Scholar Rock Resubmits Apitegromab BLA for SMA, Adds Second Fill-Finish Site; FDA Decision Eyed by Sept.

Scholar Rock (NASDAQ:SRRK) said it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug ...

Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)

Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with ...
Zacks Investment Research on MSN

SRRK stock jumps on resubmission of FDA filing for SMA drug

Shares of Scholar Rock SRRK rose 14% on Tuesday after the company announced the resubmission of a regulatory filing to the ...
InvestorsHub on MSN

Scholar Rock shares jump after FDA resubmission for SMA therapy

Scholar Rock (NASDAQ:SRRK) shares climbed about 12% on Tuesday after the company announced it had resubmitted its Biologics ...

Scholar Rock Resubmits Spinal Muscular Atrophy Drug Application to FDA

Scholar Rock Holding has resubmitted its application for its spinal muscular atrophy treatment to the Food and Drug Administration. The biopharmaceutical company said that it has sent in a new ...
BioSpace

Layoffs at Novo’s Ex-Catalent Site Despite Signs of Turnaround, Continued Investment

As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a ...

Scholar Rock rises on resubmission of U.S. marketing application for lead drug

Scholar Rock (SRRK) stock jumps as the company resubmits its marketing application for its lead drug, apitegromab, against ...
Healio

Apitegromab improves motor function in spinal muscular atrophy as early as week 8

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 ...
The American Journal of Managed Care

Muscle-Directed Therapy Apitegromab Meets Primary End Point in Phase 3 SAPPHIRE Trial of SMA

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 ...
Monthly Prescribing Reference

Apitegromab Fast Tracked for Spinal Muscular Atrophy

3D rendered Illustration of non-striated Myocytes, non-skeletal, smooth Muscle cells building muscle tissue. Apitegromab is a selective inhibitor of the inactive form of myostatin to block its ...
Monthly Prescribing Reference

Apitegromab Improves Motor Function in Spinal Muscular Atrophy

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.