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RDHL 資訊
RDHL 事件
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.
RedHill Biopharma Advances Opaganib Collaborations for EVD
RedHill Biopharma is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat Ebola virus disease or EVD, which can be fatal in approximately half of all cases, including the WHO's SOLIDARITY CORE clinical trial platform and pharma collaborations. Opaganib is an orally administered, host-directed, small molecule SPHK2 inhibitor with demonstrated antiviral properties in advanced clinical stage. Peer-reviewed published data shows opaganib's host-direction action stems from its ability to inhibit replication of viruses like SARS-CoV-2 and Ebola. In EVD specifically, opaganib offers a potential dual mechanism of action; blocking the PI3K/Akt pathway critical for filovirus entry and suppressing NLRP3 inflammasome and reducing IL-6/TNFalpha and S1P-mediated vascular permeability. The company has provided information to relevant government, industry and other organizations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications. Opaganib is an investigational new drug. It has not been approved by any regulatory authority and is not available for commercial distribution. Inclusion in the WHO CORE platform cannot be guaranteed.
RedHill Biopharma Announces RHB-204 In Vitro Testing Results
RedHill Biopharma announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis, or MAP, killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs MAP-targeted therapeutic approach to the treatment of Crohn's disease, or CD. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. RedHill is actively pursuing partnerships and collaborations for this program, in addition to non-dilutive external funding sources. The development of RHB-204 is supported by published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy.
RedHill Biopharma Presents New Data Showing Opaganib Effective for Neuroblastoma
RedHill Biopharma announced the independent presentation of new preclinical data at the 2026 American Association for Cancer Research, or AACR, Annual Meeting, showing positive effects of opaganib as potential add-on therapy in models of neuroblastoma, or NB, and triple-negative breast cancer, or TNBC. The positive NB data, from studies undertaken by Penn State University's Jeremy Hengst, and Apogee Biotechnology funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin, or OXDOX, chemotherapy combination in high-risk NB. The data showed that opaganib directly destabilized n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, regulating cell proliferation, differentiation, and apoptosis during embryonic development, a critical factor driving poor outcomes. A second poster from the University of Kansas' Colette Worcester describes in vitro model data showing that pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes. Neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0-14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S. Opaganib received FDA Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, a rare pediatric cancer, with potential for a Rare Pediatric Disease Priority Review Voucher.
RedHill Biopharma Launches Full Sales of Talicia
RedHill Biopharma (RDHL) announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings, or THI, and Cumberland Pharmaceuticals (CPIX), has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4M strategic investment. "H. pylori infection affects 35% of the U.S. adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related U.S. deaths a year," said Rick Scruggs, President of THI and RedHill's COO. Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing. RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams, are ongoing.
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