- The Portnoy Law Firm has initiated an investigation into **Fortress Biotech Inc. (FBIO)** for possible securities fraud, which may lead to a class action lawsuit on behalf of investors.  **[1429260_4fb316908d5c4b418aa25e6128e68e5b_0]** 
- This investigation follows the **October 1, 2025**, announcement by Fortress and its subsidiary, Cyprium Therapeutics, Inc., that the **FDA issued a Complete Response Letter (CRL)** for the New Drug Application (NDA) for **CUTX-101**.  **[1429260_4fb316908d5c4b418aa25e6128e68e5b_0]** 
- The CRL specifically noted **cGMP deficiencies** observed at the facility where CUTX-101 is manufactured.  **[1429260_4fb316908d5c4b418aa25e6128e68e5b_0]** 
- Following this news, the price of Fortress Biotech’s stock dropped.  **[1429260_4fb316908d5c4b418aa25e6128e68e5b_0]**

Fortress Biotech Faces Investigation Following FDA CRL for CUTX-101

- Fortress Biotech, Inc. and its majority-owned subsidiary, Cyprium Therapeutics, Inc., announced on **October 1, 2025**, that the U.S. Food and Drug Administration (FDA) issued a **Complete Response Letter (CRL)** for the New Drug Application (NDA) for **CUTX-101** (copper histidinate), intended to treat Menkes disease in pediatric patients.  **[1429260_0001104659-25-095366_fbio-20251001xex99.htm:0]** 
- The CRL noted **cGMP deficiencies** observed at the manufacturing facility during a September 2025 re-inspection.  **[1429260_0001104659-25-095366_fbio-20251001xex99.htm:0]** 
- The FDA's CRL **did not cite any other approvability concerns** or identify deficiencies in CUTX-101's efficacy and safety data.  **[1429260_0001104659-25-095366_fbio-20251001xex99.htm:0]** 
- Sentynl Therapeutics, Inc., the partner responsible for CUTX-101, expects to request a meeting with the FDA to address the concerns and pursue a prompt resubmission of the NDA.  **[1429260_0001104659-25-095366_fbio-20251001xex99.htm:0]** 
- Upon approval, Cyprium is eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV), royalties on net sales, and up to **$129 million** in aggregate development and sales milestones from Sentynl.  **[1429260_0001104659-25-095366_fbio-20251001xex99.htm:0]**

Fortress Biotech and Cyprium Therapeutics Receive FDA Complete Response Letter for CUTX-101 NDA

- Crystalys Therapeutics, in which Fortress Biotech's subsidiary Urica Therapeutics holds an equity position, closed a **$205 million Series A financing** round on **October 1, 2025**, to support the advancement of global Phase 3 clinical studies for **dotinurad**, a treatment for gout.  **[1429260_8df837fce593467fab476913799de4a3_0]** 
- Urica Therapeutics sold dotinurad to Crystalys in 2024 and is eligible to receive a **3% royalty** on future net sales of dotinurad, in addition to its minority equity position and the right to appoint a board member to Crystalys.  **[1429260_8df837fce593467fab476913799de4a3_0]** **[1429260_8df837fce593467fab476913799de4a3_1]** 
- Dotinurad is a next-generation URAT1 inhibitor that has demonstrated robust efficacy and a well-defined safety profile, leading to its approval in Japan, China, Philippines, and Thailand.  **[1429260_8df837fce593467fab476913799de4a3_0]** 
- Fortress Biotech also highlighted the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma earlier this year, which delivered approximately **$28 million upfront**, with potential for additional contingent value right payments and ongoing royalties.  **[1429260_8df837fce593467fab476913799de4a3_0]**

Fortress Biotech Announces Crystalys Therapeutics' $205 Million Series A Financing

- Fortress Biotech's majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration (FDA) issued a **Complete Response Letter (CRL)** for the New Drug Application (NDA) for **CUTX-101**, a treatment for Menkes disease in pediatric patients.  **[1429260_f87c53e9ab054ff5811cb54674fa140a_0]** 
- The CRL noted **cGMP deficiencies** at the facility where CUTX-101 is manufactured.  **[1429260_f87c53e9ab054ff5811cb54674fa140a_0]** 
- The FDA's CRL **did not cite any other approvability concerns**, nor did it identify any deficiencies in CUTX-101's efficacy and safety data.  **[1429260_f87c53e9ab054ff5811cb54674fa140a_0]** 
- Cyprium's partner, Sentynl Therapeutics, expects to request a meeting with the FDA to discuss the CRL and **pursue resubmission promptly**.  **[1429260_f87c53e9ab054ff5811cb54674fa140a_0]** 
- If approved, Cyprium is eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV), royalties on net sales of CUTX-101, and up to **$129 million** in aggregate development and sales milestones from Sentynl.  **[1429260_f87c53e9ab054ff5811cb54674fa140a_0]**

Fortress Biotech (FBIO)