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RedHill Biopharma's Opaganib Demonstrates Protective Activity Against GI-ARS, Paving The Way for Future FDA Approval vVa Animal Rule

Benzinga·12/10/2024 12:30:20
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Heightened geopolitical tensions and Homeland Security concerns call for the development of potential therapies that can be quickly and easily mobilized in the event of a mass casualty nuclear or radiological incident

There are currently no known approved therapies for gastrointestinal acute radiation syndrome (GI-ARS)

Positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirm opaganib's protective activity

Discussions now ongoing with the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), which leads the RNCP, regarding plans for the next phase of development along the U.S. Food and Drug Administration's (FDA) Animal Rule pathway to approval