Welcome to our dedicated page for Redhill Biopharm news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharm stock.
RedHill Biopharma Ltd. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
RedHill Biopharma Ltd. (NASDAQ: RDHL) announced a definitive agreement for a registered direct offering of 10,563,380 American Depositary Shares (ADSs) at $1.42 per ADS, with expected gross proceeds of approximately $15 million. The offering includes unregistered private warrants for up to 13,204,225 ADSs with an exercise price of $1.48. The net proceeds will be used for working capital, acquisitions, and general corporate purposes. The closing is anticipated on or about May 11, 2022. Cantor Fitzgerald & Co. is the exclusive placement agent for this offering.
RedHill Biopharma (Nasdaq: RDHL) announced that its oral drug candidate, opaganib, demonstrated potent in vitro activity against the Omicron variant of SARS-CoV-2, as confirmed by research from the University of Hong Kong. Opaganib's mechanism aims to address viral mutations, maintaining efficacy against Omicron sub-variants. Phase 2/3 clinical data revealed improved viral RNA clearance, reduced mortality by 70%, and faster recovery times in hospitalized patients. Regulatory discussions for potential approval are ongoing across several regions.
RedHill Biopharma (NASDAQ:RDHL) announced promising results for opaganib, a treatment for COVID-19, showing potent in vitro activity against the Omicron variant. Research by The University of Hong Kong indicates that opaganib acts through a unique mechanism that could remain effective against various viral mutations, including sub-variants BA.2 and XE. Phase 2/3 trials revealed a 70% reduction in mortality and a 34% faster recovery time in treated patients. Regulatory discussions for approval are underway across multiple regions, supporting opaganib's potential as a treatment option.
RedHill Biopharma (NASDAQ: RDHL) reported record revenues of $85.8 million for 2021, a 33.2% increase from 2020, driven by the strong performances of Talicia® and Movantik®. The Q4 net revenues were $22.1 million, slightly up from Q3. However, a $9 million impairment related to Aemcolo® resulted in a gross profit decline to $2.7 million. Operating loss for Q4 increased to $20.7 million. The company is focused on cost-containment and expects profitability from commercial operations in 2022. Positive late-stage data for COVID-19 drugs opaganib and RHB-107 were highlighted.
RedHill Biopharma (Nasdaq: RDHL) announced an exclusive licensing agreement with Kukbo Co. Ltd. for its oral drug opaganib, aimed at treating COVID-19 in South Korea. The agreement includes a $1.5 million upfront payment and potential milestone payments of up to $5.6 million, alongside royalties on net sales. Given the recent surge of COVID-19 cases in South Korea, with nearly 4 million cases reported in March, the partnership aims to expedite the drug's availability. Opaganib has shown promise in clinical trials for COVID-19, including improved viral clearance and reduced mortality.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will announce its fourth quarter and full year 2021 financial results on March 17, 2022. A conference call is scheduled for 8:30 a.m. EDT, providing insights into key operational highlights. RedHill focuses on gastrointestinal and infectious diseases, with products like Movantik, Talicia, and Aemcolo. Ongoing late-stage clinical trials include RHB-204 for pulmonary diseases and opaganib for COVID-19 and cancer. More information will be available on their website.
RedHill Biopharma (Nasdaq: RDHL) reported positive top-line results from the Phase 2 study of RHB-107 (upamostat) in non-hospitalized COVID-19 patients. The study, predominantly conducted in the U.S., showed a 100% reduction in hospitalization among treated patients (0 out of 41) versus 15% in the placebo group. Additionally, there was an 87.8% reduction in severe COVID-19 symptoms. RHB-107 demonstrated good safety and tolerability, with potential effectiveness against emerging viral variants. The company plans to discuss next steps with regulatory authorities.
RedHill Biopharma Ltd. (Nasdaq: RDHL) reported strong sales growth in Q4 2021, driven by enhancements in its salesforce and cost control measures. The company is positioned to achieve commercial profitability in 2022, alongside advancing its late-stage pipeline, particularly with the orally-administered opaganib for COVID-19. Preliminary financial data indicates a potential record quarterly revenue, though it remains subject to year-end audit adjustments. Regulatory discussions are ongoing for opaganib's approval.
On February 7, 2022, RedHill Biopharma (NASDAQ: RDHL) announced significant findings from the Phase 2/3 study of its oral drug opaganib for severe COVID-19 patients. The analysis revealed a remarkable 70.2% reduction in mortality for patients receiving opaganib alongside remdesivir and corticosteroids, with a mortality rate of 6.98% compared to 23.4% for placebo (p-value=0.034). Additionally, opaganib showed a 34% improvement in recovery time (p-value=0.013). Regulatory discussions are ongoing, with potential emergency applications planned in several countries in the first half of 2022.
RedHill Biopharma (Nasdaq: RDHL) reported a prespecified analysis from its Phase 2/3 study of oral opaganib, showing a significant improvement in median viral RNA clearance in severely ill COVID-19 patients. Opaganib achieved a median clearance time of 10 days compared to a placebo, which did not reach median clearance by 14 days, indicating a hazard ratio of 1.34 (p-value 0.043). Additionally, opaganib demonstrated a 62% reduction in mortality in a post-hoc analysis. As RedHill discusses regulatory approval pathways, these results underline opaganib's potential as an antiviral treatment.