Complete Response Letters

Scholar Rock, Inc.: BLA 761463

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Sep 22, 2025

Any additional specific details of this required postmarketing study, including a timetable and annual reporting requirements, will be described more fully in the approval letter for this application, if it is approved.

Complete Response Letter · Sep 22, 2025 · p. 4Open the letter at p. 4 ↗CRL_BLA761463_20250922:p3:s2

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Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.