Redhill Biopharm Stock Price, News & Analysis

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.

RedHill Biopharma Ltd. (Nasdaq: RDHL) has signed an exclusive license agreement with Gaelan Medical for Talicia®, an H. pylori therapy, in the UAE. Under the deal, RedHill will receive an upfront payment of $2 million and may earn milestone payments and royalties on sales. Gaelan Medical will exclusively commercialize Talicia in the UAE and has a right of first refusal for the Gulf region. The agreement comes amid rising H. pylori infection rates in the UAE, affecting 41% of the population, highlighting the need for effective treatment options.