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Complete Response Letters

Disc Medicine, Inc.: bitopertin

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

Complete Response Letter, Feb 13, 2026

With respect to the first factor, we agree that Trial 201, one adequate and well controlled trial, demonstrated an effect on its primary endpoint.
Complete Response Letter · Feb 13, 2026 · p. 2Open the letter at p. 2 ↗CRL_NDA220707_20260213:p1:s32
Confirmatory evidence was provided from a second, randomized, open-label rial, Trial 202, in which bitopertin 60 mg was superior to bitopertin 20 mg for the primary biomarker endpoint of percent change from baseline to Day 169 of whole blood metalree PPIX in adult and adolescent patients with EPP or XLP (p=0.018).
Complete Response Letter · Feb 13, 2026 · p. 2Open the letter at p. 2 ↗CRL_NDA220707_20260213:p1:s35

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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.