FDA Approval ProcessSRRK held their Type A meeting with FDA to discuss the re-submission of their BLA for apitegromab in spinal muscular atrophy, highlighting constructive dialogue with FDA and now anticipating re-submission, approval, and US launch in 2026.
Market PotentialSRRK's pre-launch activities include efforts to engage with prescribers, the patient/caregiver community, and expand market access, which could set up apitegromab for a strong launch and highlight the multi-billion dollar market for existing therapies in SMA.
Non-dilutive FinancingNon-dilutive financing also provides more stability for Scholar Rock as they continue to wait for their first Earnings.