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Scholar Rock Holding (SRRK) investor relations material
Scholar Rock Holding Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary4 Dec, 2025
Key milestones and leadership changes
Achieved positive pivotal Phase 3 results for apitegromab in spinal muscular atrophy (SMA) in Q4 2024, leading to a BLA filing in January 2025.
FDA accepted the BLA under priority review in April 2025 due to high unmet need in SMA.
Leadership transition in April 2025, with a new CEO and experienced executives joining to drive commercialization and growth.
Advanced a Phase 2 cardiometabolic study showing muscle preservation benefits with the myostatin platform.
Announced plans to reveal a second indication for apitegromab and progress a new myostatin inhibitor, SRK-439, with initial data expected in 2026.
Clinical trial outcomes and product profile
Phase 3 Sapphire study was a 188-patient, double-blind, placebo-controlled trial with all patients on background SMN-targeted therapies.
Apitegromab showed statistically significant improvement in motor function versus placebo, with a p-value of 0.019.
About one-third of patients achieved a three-point improvement in motor function, compared to 12% on placebo.
Safety profile remained consistent and favorable, supporting a strong launch outlook in the U.S. and globally.
Regulatory and manufacturing updates
Received a complete response letter (CRL) from the FDA in September 2025 due to compliance issues at the fill/finish facility, not related to efficacy or safety.
Novo Nordisk’s facility received an OAI classification and a public warning letter, requiring remediation and reinspection before approval.
Type A FDA meeting in November 2025 was collaborative, with guidance for resubmission and potential U.S. launch in 2026.
Transitioning to a new fill/finish facility, with commercial capacity expected to be qualified later in 2026.
What's the critical path for Catalent remediation?
Payer strategy for add-on therapy coverage?
SRK-439: What's the 2026 readout expectation?
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Next Scholar Rock Holding earnings date
Q4 202527 Feb, 2026
Next Scholar Rock Holding earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Scholar Rock Holding Corp is a biopharmaceutical company engaged in the discovery and development of innovative medicines for the treatment of serious diseases, with a focus on those in which signaling by protein growth factors plays a fundamental role. The company's research and development efforts include Apitegromab, an inhibitor of the activation of latent myostatin that has completed Phase 3 clinical trials for the treatment of spinal muscular atrophy, and SRK-181, which is in clinical trials for the treatment of cancers resistant to checkpoint inhibitor therapies. Scholar Rock is also developing a pipeline of novel product candidates aimed at transforming the lives of patients suffering from a range of serious diseases, including neuromuscular disorders, cancer, fibrosis, and iron-restricted anemia. cholar Rock Holding Corp is headquartered in Cambridge, Massachusetts, and its shares are listed on the Nasdaq.
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