Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.
Applications with the US Food and Drug Administration and European Medicines Agency are expected in Q1 2025, and a US launch in Q4.
Scholar Rock also plans to focus on three key priorities in 2025, including commercialization, expanded use of apitegromab, and advancing anti-myostatin program for cardiometabolic disorders.
Key milestones for the company include starting the phase 2 trial in SMA patients under two years old by mid-2025, phase 2 obesity trial data in Q2, and filing an investigational new drug application for SRK-439 to treat obesity in Q3, Scholar Rock said.
Scholar Rock said its current cash and equivalent funds are enough to cover operation through Q4 2026.
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