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Noticias de RDHL
Eventos de RDHL
RedHill Biopharma Confirms RHB-204's Killing Capability on MAP
RedHill Biopharma announced the confirmation of RHB-204's killing capability on Mycobacterium avium subspecies paratuberculosis, or MAP, and RHB-204's comparability to RHB-104 MAP-killing, following two sets of in vitro studies, undertaken by microbiology centers, in both long-term intracellular culture and spot and phage assays. The two sets of studies support the potential for RHB-204's role in MAP-related Crohn's disease through demonstrated RHB-204 comparability to RedHill's RHB-104, which met the primary endpoint with statistical significance of its positive Phase 3 clinical trial, showing RHB-104 plus standard of care to be 64% more effective than SoC alone, in treating CD compared to the placebo. The positive results were seen across a range of MAP strains, suggestive of both potential human and veterinary utility. The studies also showed that RHB-204 did not induce tolerance in the strains during the short exposure periods used in the studies, suggesting that further consecutive dosing could add to the effect. RHB-204 is patent protected through 2041 and has been granted FDA Fast Track, Orphan Drug and QIDP and EU Orphan designations. RedHill is actively pursuing partnerships and collaborations for this program, including through innovation development grant applications.
RedHill Biopharma Acquires Exclusive Global Commercialization Rights to Rebyota and Clenpiq
RedHill Biopharma announced the transformational acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, from Ferring Pharmaceuticals, as part of Ferring's ongoing strategic refocusing. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have executed a clear strategic sequence. We have monetized Talicia for $18M cash upfront, plus $35 million in potential upside, used $12M to secure commercialization rights to two established, proprietary, FDA-approved gastrointestinal drugs, that collectively generated approximately $37.5M in U.S. net sales in 2025, and emerged with a materially larger, fully controlled commercial business and a stronger liquidity position. Rebyota and Clenpiq are expected to generate a positive cash contribution to RedHill. This, combined with RedHill's experienced and lean commercial team and proven development capabilities, creates a scalable foundation for further growth, including additional acquisition of complementary revenue-generating products." Under the terms of the agreement, RedHill obtained an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq, for an upfront payment to Ferring of $12M, plus tiered royalties on net sales and potential milestones. Ferring retains its Rebyota manufacturing facilities, and Ferring will continue to supply Rebyota through the term of the agreement.
RedHill Biopharma Acquires Global Commercialization Rights to Rebyota and Clenpiq
RedHill Biopharma announced the acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, from Ferring Pharmaceuticals, as part of Ferring's ongoing strategic refocusing. Under the terms of the agreement, RedHill obtained an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq, for an upfront payment to Ferring of $12M, plus tiered royalties on net sales and potential milestones. Ferring retains its Rebyota manufacturing facilities, and Ferring will continue to supply Rebyota through the term of the agreement.
RedHill Biopharma Sells Talicia Business for $18M
RedHill Biopharma announced the divestment of its Talicia business to a subsidiary of Apotex Health for an upfront payment of $18M plus up to an additional $35M in potential payments based on worldwide net sales milestones. Under the terms of the agreement, RedHill received $18M in cash and has the potential to receive up to an additional $35M in payments based on worldwide net sales milestones from Apotex. In return, Apotex will receive RedHill's 70% interest in Talicia, following Apotex's prior acquisition of Cumberland Pharmaceuticals Inc.'s U.S. branded business, which included Cumberland Pharmaceuticals Inc.'s 30% ownership in Talicia.
RedHill Biopharma Completes Private Placement of 8.57 Million ADS
RedHill Biopharma announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares, each ADS representing ten thousand ordinary shares of the company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of 70c per ADS and accompanying warrants in a private placement. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date, and the Series A-2 warrants have an exercise price of 70c per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date. The private placement is expected to close on June 22, subject to the satisfaction of customary closing conditions. The gross proceeds to the company from this offering are expected to be approximately $6M, before deducting the placement agent's fees and other offering expenses payable by the company. The potential additional gross proceeds to the company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4M. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
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