SEP 14 2026
Scholar Rock — Isembyld (apitegromab-mstn) $SRRK
for Spinal muscular atrophy
FDA approves apitegromab-mstn for children and adults with spinal muscular atrophy.
About
Spinal muscular atrophy is a genetic neuromuscular disorder that causes progressive muscle weakness and wasting, typically beginning in the arms, legs, and respiratory system. Isembyld (apitegromab) is an antibody designed to block a specific growth factor that acts as a natural brake on muscle mass. By inhibiting this brake, the drug may help preserve or improve motor function in patients who are already receiving other SMA therapies.
Pivotal trial
This Phase 3 trial (Study SRK-015-003) was conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and were receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Isembyld
- Scholar Rock’s Isembyld approval sets up rapid sales ramp - S&P Global
- Scholar Rock gains as Isembyld approval momentum and a fresh price-target increase lift sentiment - Quiver Quantitative
- Scholar Rock Holding (SRRK) Wins FDA Approval for ISEMBYLD. Can Add-On Use Scale? - Yahoo Finance
- Scholar Rock (NASDAQ: SRRK) Updates FDA Safety Requirements for ISEMBYLD Post-Approval - Kalkine Media
- Scholar Rock (SRRK) Stock Fair Value Edges Higher After Isembyld Approval And Analyst Revisions - Yahoo Finance
Sponsor Watch — recent news on Scholar Rock
- Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
- Scholar Rock Holding (SRRK) Wins FDA Approval for ISEMBYLD. Can Add-On Use Scale?
- Scholar Rock (SRRK) Stock Fair Value Edges Higher After Isembyld Approval And Analyst Revisions
- Scholar Rock Faces Early Isembyld Launch Friction From FDA Safety Requirements, Truist Says
- Scholar Rock Shares Rise 9.1% After FDA Approves ISEMBYLD for Spinal Muscular Atrophy