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Scholar Rock
Scholar Rock (SRRK) investor relations material
Scholar Rock 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary12 Jan, 2026
Strategic vision and innovation
Positioned for a transformative 2026, focusing on rare neuromuscular disorders with myostatin biology leadership and muscle-targeted therapies.
Apitegromab is the first myostatin inhibitor to succeed in a pivotal phase III study, showing clinically meaningful benefit in SMA.
Plans to expand apitegromab to FSHD and other neuromuscular diseases, with Phase 2 FORGE study in FSHD to begin mid-2026.
Building a 50-country operating platform to serve global SMA patients, with launches in the U.S. and Europe in 2026, starting in Germany.
Advancing a pipeline including subcutaneous apitegromab and SRK-439, with Phase 1 and 2 studies underway and topline data for SRK-439 expected in H2 2026.
Clinical and regulatory progress
Phase III SAPPHIRE trial showed statistically significant motor function improvement in SMA patients on SMN-targeted therapies.
95% of patients remain in long-term extension trials, supporting safety and efficacy.
BLA resubmission and U.S. launch expected in 2026, pending FDA approval and remediation steps at the fill-finish facility.
EMA decision for apitegromab expected mid-2026, with initial launch in Germany and other countries to follow.
Ongoing Phase 2 OPAL study evaluating apitegromab in infants and toddlers with SMA.
Commercial opportunity and market strategy
SMA market for SMN-targeted therapies projected at $5 billion in 2025; apitegromab seen as a $2 billion+ opportunity.
U.S. market represents about a third of the opportunity, with Europe and rest of world comprising the remainder.
Commercial supply is ready for launch, with sufficient drug substance and finished product available.
U.S. commercial team engaging prescribers, payers, and advocacy groups; Europe launch readiness progressing, including compassionate use programs.
Expansion into Asia-Pacific and Latin America planned after U.S. and Europe.
Outcome of FDA/Novo Q1 meeting on BLA?
Prioritize global SMA markets beyond US/EU?
Expected impact of SRK-439 Phase 1 data?
Partial view of Summaries dataset, powered by Quartr API
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Next Scholar Rock earnings date
Q4 202527 Feb, 2026
Scholar Rock
Next Scholar Rock 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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