RedHill Biopharma Receives FDA Guidance On Approval Path For RHB-204 Crohn's Disease Program Following Type C Meeting

Author: Benzinga Newsdesk | July 21, 2025 09:04am

The positive FDA feedback allows for:

• A novel Phase 2 RHB-204[1] study, planned to be the first ever clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population
• Groundbreaking approach testing MAP as a root cause of CD, supporting RHB-204 as a potential paradigm-shifting therapy treating both the suspected cause of Crohn's disease and its symptoms 
• RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection diagnostics – the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program
• Innovative design enables a smaller sample size allowing for lower study costs and faster time to completion

Funding for this ground-breaking program expected to be non-dilutive; Grant application submitted and discussions ongoing for additional non-dilutive financing

Patent protected through 2041, orally-administered RHB-204, a next-generation optimized formulation of RedHill's RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104[2] Phase 3 safety and efficacy results, which delivered a statistically significant 64% improvement in efficacy[3]

Expected transferal of pediatric orphan drug designation to RHB-204 as well as potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher

The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033[4], presenting significant commercial potential for new, paradigm changing, FDA-approved therapies

RALEIGH, N.C. and TEL AVIV, Israel, July 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration (FDA), following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company's potentially groundbreaking RHB-204 Crohn's disease (CD) development program.

Posted In: RDHL