RedHill Biopharma Files 6-K, Hints at U.S. Development

TL;DR

RHBP filed a 6-K, press release title suggests a US development. Details TBD.

AI Summary

RedHill Biopharma Ltd. filed a Form 6-K on October 15, 2024, to report a press release titled "RedHill Biopharma Secures U.S.". The filing indicates the company is a foreign private issuer and files annual reports on Form 20-F. The specific details of the press release, including any dollar amounts or further context, are not fully provided in the excerpt.

Why It Matters

This filing signals a potential development or announcement from RedHill Biopharma regarding its U.S. operations or intellectual property, which could impact its stock value and future business strategy.

Risk Assessment

Risk Level: medium — The filing itself is routine, but the lack of specific details in the provided text about the U.S. development creates uncertainty.

Key Numbers

• 20241015 — Filing Date (Date of the 6-K submission)

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• 001-35773 (company) — SEC File Number
• 20-F (company) — Annual Report Form
• 6-K (company) — Filing Form

FAQ

Filing Documents

• zk2432138.htm (6-K) — 40KB
• image00002.jpg (GRAPHIC) — 4KB
• 0001178913-24-003282.txt ( ) — 47KB

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: October 14, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer 2 Press Release RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV) -- The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential approval as an MCM for EBOV -- Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase in survival in an in vivo EBOV model. The BARDA research and development contract provides initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and contain EBOV outbreaks -- This year marks the 10 th anniversary of the West Africa Ebola epidemic in which 11,000 people died, and there is still an urgent need for effective and useable therapies, with EBOV proving fatal in around half of all cases according to the World Health Organization (WHO) 1 -- Opaganib, a novel potentially broad-acting drug, has shown mutation-resistant antiviral and anti- inflammatory activity, likely to directly impact vascular health - one of the main targets for EBOV dysfunction. It is believed to be the first host-directed molecule to show activity in EBOV in vivo and represents an alternative host-directed therapeutic strategy for biodefense and global health preparedness. Additional U.S. government collaborations with opaganib are ongoing -- Significant geopolitical and logistical challenges ex

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 Ebola and other indications. 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'

View Full Filing

View this 6-K filing on SEC EDGAR