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Dec 31, 2024
Scholar Rock Q4 2024 Earnings Report
Scholar Rock reported full year financial results and highlighted business progress.
Key Takeaways
Scholar Rock reported its full year 2024 financial results, highlighting the submission of the apitegromab BLA, progress towards MAA submission, upcoming data readouts, and a strong cash position.
Submitted apitegromab U.S. Biologics License Application (BLA) for patients with spinal muscular atrophy in January 2025; U.S. launch anticipated in 4Q 2025.
Remain on track to submit European Union marketing authorisation application (MAA) in 1Q 2025.
Topline data from Phase 2 EMBRAZE trial evaluating apitegromab vs placebo in adult patients with obesity receiving tirzepatide expected in 2Q 2025.
Ended 2024 with approximately $437 million in cash, cash equivalents, and marketable securities.
Forward Guidance
Scholar Rock is focused on advancing its pipeline, including regulatory submissions and clinical trials for apitegromab and SRK-439, with key milestones expected in the near term.
Positive Outlook
- Apitegromab BLA was submitted to the U.S. FDA in January 2025.
- Company remains on track to submit MAA to the European Medicines Agency in 1Q 2025.
- Topline data from Phase 2 EMBRAZE trial is expected in 2Q 2025.
- IND application for SRK-439 is anticipated in 3Q 2025.
- U.S. commercial launch of apitegromab is anticipated in 4Q 2025.
Challenges Ahead
- The efficacy and safety of apitegromab, SRK-181, and SRK-439 have not been established.
- Apitegromab, SRK-181, and SRK-439 have not been approved for any use by the FDA or any other regulatory agency.
- Clinical data may not be sufficient to support regulatory approval.
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