secwatch.observer — SEC 8-K summary
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Issuer:     Fortress Biotech, Inc. (FBIO)
CIK:        0001429260
Form:       8-K
Filed at:   2025-01-16T23:59:59+00:00
Accession:  0001558370-25-000247
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends PDUFA date for Fortress subsidiary's NDA for CUTX-101 to Sep 30, 2025
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- FDA extended target action date for CUTX-101 (Copper Histidinate) NDA to September 30, 2025.
- Sentynl assumed full responsibility for CUTX-101 development and commercialization in Dec 2023.
- Cyprium retains ownership of any Priority Review Voucher; eligible for up to $129M milestones plus royalties.
- Fortress owns approximately 76% of Cyprium Therapeutics.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/0001558370-25-000247-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1429260/000155837025000247/fbio-20250116x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-000247

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer