RedHill Biopharma Files 6-K, Incorporates Press Release

TL;DR

RHBP filed a 6-K with a new press release attached - check it for updates.

AI Summary

RedHill Biopharma Ltd. filed a Form 6-K on September 3, 2024, to report the issuance of a press release. The press release, titled "New Peer-Reviewed Publicatio", is incorporated by reference into this filing. The company is a foreign private issuer based in Israel and files annual reports on Form 20-F.

Why It Matters

This filing indicates RedHill Biopharma is disseminating new information to the public, likely related to its business or clinical developments, which could impact investor sentiment.

Risk Assessment

Risk Level: low — This filing is a routine report of a press release and does not contain new financial data or significant operational changes.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Filer of the 6-K
• 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel (location) — Principal executive offices
• September 2024 (date) — Reporting period for the Form 6-K
• Form 20-F (document) — Annual report form filed by the registrant
• New Peer-Reviewed Publicatio (document) — Title of the incorporated press release

FAQ

Filing Documents

• zk2431978.htm (6-K) — 39KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-002924.txt ( ) — 464KB

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: September 3, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms -- The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates that FiO2 of greater than 60% may represent a threshold level for disease severity, and may potentially be a patient selection biomarker, an important finding for future therapeutic strategies and studies -- With 30,000 Americans dead due to COVID-19 so far this year according to the World health Organization 1 , new, effective and safe therapies are still very much needed -- With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles in oncology indications, viral infection, nuclear/radioprotection and other inflammatory diseases TEL-AVIV, Israel / RALEIGH, NC, September 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication of data, in the journal Microorganisms 2 , from the 57-site, randomized, placebo-controlled, double-blind phase 2/

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 COVID-19. 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 regain compliance with the Nasdaq Capital Market's minimum bid price 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-sta

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View this 6-K filing on SEC EDGAR