Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a private placement agreement with a single investor for a $6 million convertible promissory note. This issuance will convert into American Depositary Shares (ADS) and comes with warrants, potentially enhancing the company's capital structure. The funding will be disbursed in three tranches of $2 million, $1 million, and $3 million, with the first tranche available at closing. RedHill plans to use the proceeds for general working capital, acquisitions, and research and development. The warrants will have an exercise price of $0.21 and a three-year term.

RedHill Biopharma (Nasdaq: RDHL) has announced that its drug opaganib has been selected by the NIH's Radiation and Nuclear Countermeasures Program (RNCP) for testing as a potential treatment for Acute Radiation Syndrome (ARS). This collaboration aims to expedite the development of opaganib, a novel oral medication that may mitigate radiation damage. Following FDA guidance, the RNCP will validate opaganib's efficacy in preclinical animal models. Opaganib's mechanism involves reducing inflammatory damage and protecting hematopoietic stem cells from radiation exposure. The ongoing partnership could lead to its stockpiling for emergency use if approved.

RedHill Biopharma (Nasdaq: RDHL) announced that the National Institutes of Health's Radiation and Nuclear Countermeasures Program has selected opaganib for testing as a potential treatment for Acute Radiation Syndrome (ARS). This collaboration aims to validate opaganib's efficacy in pre-clinical animal models under the RNCP contract. Following recent FDA guidance on the Animal Rule for opaganib, the company expects the collaboration to enhance its development program, potentially leading to FDA approval for use in radiological emergencies. Opaganib is an oral pill with a five-year shelf-life, designed for easy administration during such incidents.

RedHill Biopharma has announced a positive outcome from its pre-Marketing Authorisation Application (MAA) meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for its drug RHB-102 (BEKINDA). The drug aims to manage nausea and vomiting induced by chemotherapy and radiotherapy (CINV/RINV). The MAA submission is expected in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic in the UK, addressing a significant market need, given that 70-80% of patients undergoing chemotherapy experience these symptoms. The global market for CINV/RINV is projected to exceed $10 billion by 2031.

RedHill Biopharma announced that the UK MHRA has given a positive opinion on RHB-102 (Bekinda) for treatment of chemotherapy and radiotherapy-induced nausea and vomiting (CINV/RINV). This feedback supports the planned submission of a UK Marketing Authorisation Application in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic drug in the UK for CINV/RINV. The global market for CINV/RINV treatments is projected to exceed $10 billion by 2031, with significant growth expected in the UK.

RedHill Biopharma (Nasdaq: RDHL) announced a positive outcome from a scheduled Type B meeting with the FDA, receiving guidance on the regulatory pathway for its investigational drug opaganib to treat Acute Radiation Syndrome (ARS). The FDA's Animal Rule allows the use of animal studies in place of human trials when ethical concerns arise. Opaganib, a small molecule with a five-year shelf life, could be stockpiled by governments for emergency situations. Collaboration with U.S. agencies is planned for further development. A recent study highlighted opaganib's potential against radiation toxicity, supporting its role in homeland security.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that it has extinguished all debt obligations under its Credit Agreement with HCR, transferring rights to Movantik® in exchange. This strategic decision allows RedHill to become debt-free, freeing cash flow previously used for debt servicing. HCR will take on post-closing liabilities while RedHill retains pre-closing liabilities concerning Movantik. RedHill will provide transition services to HCR for up to 12 months, generating revenue during this period. The company aims to replace Movantik revenues with new products and maximize the potential of its existing drug portfolio.

RedHill Biopharma has received a Notice of Allowance from the USPTO for a patent covering RHB-204, a promising treatment for Non-tuberculosis Mycobacteria (NTM) disease. This patent is expected to extend protection until 2041. RHB-204 is currently in a Phase 3 study in the U.S. as the first stand-alone standard of care for NTM disease caused by MAC infection. It has received multiple FDA designations, including Fast Track and Orphan Drug status, ensuring market exclusivity for up to 12 years in the U.S. Discussions with potential partners for RHB-204 are ongoing, highlighting its commercial potential in addressing a growing public health concern.

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