Fortress Biotech: Nagbigay ang FDA ng CRL para sa CUTX-101 NDA

Nagbigay ang FDA ng Complete Response Letter para sa CUTX-101 NDA dahil sa mga kakulangan sa cGMP sa pasilidad ng pagmamanupaktura. Hindi tinukoy ng CRL ang anumang kakulangan sa datos ng bisa o kaligtasan. Ang Sentynl, ang kasosyo na ngayon ang may pananagutan sa pag-unlad, ay nagbabalak na tugunan ang mga isyu at muling isumite ang NDA.

Mahahalagang fact

Na-file: Okt 1, 2025, 12:45 PM
Kaganapan: Complete response letter
Direksyon: Negatibo
Kumpanya: FBIOFortress Biotech
Asset: CUTX-101
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 14, 2026 · Complete response letter

Sipi mula sa source

EX-99 2 fbio-20251001xex99.htm EX-99 Exhibit 99.1 Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101 Miami, FL – October 1, 2025 – Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”) assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. Cy

SEC 8-K