https://www.businesswire.com/news/home/20250923756342/en/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-Indiana-LLC-Fill-Finish-Facility
FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal...
Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atr...
https://www.hmpgloballearningnetwork.com/site/neuro/news/apitegromab-improves-motor-function-children-sma
Apitegromab Improves Motor Function in Children With SMA
Treatment with the fully human monoclonal antibody apitegromab was associated with statistically significant improvements in motor function scores compared...
motor functionin childrenapitegromabimprovessma
https://www.businesswire.com/news/home/20260331950583/en/Scholar-Rock-Resubmits-Biologics-License-Application-BLA-to-FDA-for-Apitegromab-for-Treatment-of-Children-and-Adults-with-Spinal-Muscular-Atrophy-SMA
Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of...
Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) an...
biologics license application
https://www.stjude.org/care-treatment/clinical-trials/sapphire-spinal-muscular-atrophy.html
SAPPHIRE: Efficacy and Safety of Apitegromab in Patients with Spinal Muscular Atrophy Receiving...
This study will test how well the drug apitegromab improves motor function in children with spinal muscular atrophy when added to Evrysdi and Spinraza therapy.
efficacy and safety