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 ...
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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 ...

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 ...

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 ...
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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 ...
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 ...
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FDA receives biologics license application for apitegromab in spinal muscular atrophy

Please provide your email address to receive an email when new articles are posted on . A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its ...
Monthly Prescribing Reference

Apitegromab Gets Priority Review for Spinal Muscular Atrophy

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 ...

Scholar Rock Holding Corporation (SRRK) Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress Transcript

Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress March 31, 2026 8:00 ...
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FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent ...

Scholar Rock (SRRK) intends to resubmit the apitegromab Biologics License Application (BLA) upon resolution of Catalent Indiana LLC-related observations CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar ...
Benzinga.com

Scholar Rock Sets Sights on $2 Billion Apitegromab Revenue Amid Spinal Muscular Atrophy Market Growth

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 ...
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.