Fortress Biotech Announces an Exclusive License Agreement for FB-607 for the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D)
Key Highlights
- ➤Fortress subsidiary licenses FB-607 from Cedars-Sinai for IBS-D development
- ➤FB-607 combines rifaximin and N-acetylcysteine in an enteric-coated formulation
- ➤Phase 2 study NCT06727422 evaluates FB-607’s safety, efficacy and pharmacokinetics
- ➤IBS-D affects an estimated 4.5 million U.S. adults
- ➤License also covers potential FB-607 development for hepatic encephalopathy
Expert Statements
Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer of Fortress Biotech
“We are excited to develop FB-607 for the treatment of IBS-D and potentially provide a therapeutic option for patients that continue to have significant unmet need. IBS-D alone affects an estimated 4.5 million U.S. adults, and we believe there is a sizeable market for this opportunity, as these patients struggle with chronic symptoms and frequent relapses that can make their day-to-day life challenging.”
MIAMI, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, today announced that a majority-owned and controlled subsidiary of Fortress has entered into an exclusive licensing agreement with Cedars-Sinai to develop FB-607, a novel approach to potentially address the symptoms of irritable bowel syndrome with diarrhea (“IBS-D”).
FB-607 is a proprietary enteric-coated, pH-sensitive coformulation of rifaximin and N-acetylcysteine (“NAC”) and is designed to target the intestinal mucus layer and biofilms to improve outcomes for patients, including those who do not fully respond to rifaximin alone. The license agreement also enables the development of FB-607 for other indications, including hepatic encephalopathy.
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