RedHill's Opaganib Shows Radioprotective Activity in New Study

TL;DR

RedHill's opaganib confirmed effective for radiation sickness, talks with US gov ongoing.

AI Summary

RedHill Biopharma Ltd. announced on December 10, 2024, that a new study by the RNCP/NIAID confirmed the radioprotective activity of its drug, opaganib, for gastrointestinal acute radiation syndrome (GI-ARS). The company is in ongoing discussions with the U.S. government regarding the advanced development of opaganib for this indication.

Why It Matters

This confirmation of opaganib's effectiveness against GI-ARS could lead to significant government funding and development for a critical medical countermeasure.

Risk Assessment

Risk Level: medium — The filing indicates ongoing discussions and study results, but no definitive agreements or funding amounts are disclosed, leaving the outcome uncertain.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Opaganib (drug) — Drug candidate for GI-ARS
• RNCP/NIAID (organization) — Study sponsor
• U.S. Government (government) — Potential partner for advanced development
• December 10, 2024 (date) — Date of announcement

FAQ

Filing Documents

• zk2432448.htm (6-K) — 37KB
• image00002.jpg (GRAPHIC) — 4KB
• 0001178913-24-003951.txt ( ) — 44KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. REDHILL BIOPHARMA LTD. (the "Registrant") Date: December 10, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer 2 Press Release Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development 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 TEL-AVIV, Israel / RALEIGH, NC, December 10, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive results from new in vivo studies of opaganib 1 as a treatment for gastrointestinal acute radiation syndrome (GI-ARS), undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib, that further confirm opaganib's protective activity in models of GI-ARS. The Company, toge

Forward-Looking Statements

Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of opaganib in the treatment of GI-ARS. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage develop

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