10:59 AM EDT, 07/21/2025 (MT Newswires) -- RedHill Biopharma ( RDHL ) said Monday it received positive feedback and guidance on a pathway to approval from the US Food and Drug Administration for RHB-204, its potential Crohn's disease treatment.

The positive feedback allows for a phase 2 study that will be the first trial in Crohn's disease to test a specifically defined population of so-called MAP-positive patients, the company said.

"Testing MAP as a root cause of Crohn's, this groundbreaking approach could potentially make RHB-204, if approved, a paradigm-shifting new therapy treating both the suspected cause of the disease and its symptoms," the company said.

RedHill shares were more than 15% higher in recent trading.

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