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. (Nasdaq: RDHL) is a specialty biopharmaceutical company whose news flow centers on gastrointestinal diseases, infectious diseases and oncology. Company press releases furnished on Form 6-K highlight both commercial developments around its FDA-approved H. pylori therapy Talicia® and clinical and preclinical updates from its late-stage pipeline, including opaganib (ABC294640), RHB-102 (Bekinda®), RHB-204 and RHB-107 (upamostat).
Investors following RDHL news can expect regular updates on Talicia’s commercialization, such as U.S. co-commercialization with Cumberland Pharmaceuticals, ex-U.S. licensing deals in regions like the Middle East, and milestone and royalty payments from international launches. RedHill also issues news on Talicia’s clinical positioning, including its status as a first-line option in American College of Gastroenterology guidelines and its role as a low-dose rifabutin-based therapy designed to address H. pylori antibiotic resistance.
On the development side, RedHill’s news frequently covers pipeline data and regulatory plans. Examples include positive in vivo and clinical results for opaganib in oncology and viral indications, Phase 2 and Phase 3 outcomes for RHB-102 in gastroenteritis, gastritis and IBS-D, and plans for RHB-102 in GLP-1/GIP receptor agonist therapy-associated gastrointestinal side effects. Updates also describe RHB-107’s late-stage development in non-hospitalized symptomatic COVID-19 and RHB-204’s planned studies in Crohn’s disease and pulmonary nontuberculous mycobacteria disease.
RedHill’s news feed additionally reports on Nasdaq listing compliance matters, capital-raising activities, and legal proceedings, such as New York Supreme Court judgments and related enforcement steps in the Kukbo litigation. For readers tracking RDHL, this page aggregates these corporate, clinical, regulatory and legal announcements in one place, allowing a consolidated view of the company’s ongoing activities and disclosures.
RedHill Biopharma announced that the European Commission has granted Orphan Drug Designation to RHB-204 for treating nontuberculous mycobacteria (NTM) infections. This designation provides eligibility for 10 years of EU market exclusivity post-approval. Additionally, RHB-204 has received U.S. FDA Fast Track, Orphan, and QIDP designations, extending exclusivity to 12 years in the U.S. The company is currently advancing a Phase 3 study in the U.S. to evaluate RHB-204's efficacy and safety against pulmonary NTM disease.
RedHill Biopharma (Nasdaq: RDHL) announced important upcoming presentations at major medical conferences related to its products Talicia, Opaganib, and RHB-107. Talicia will be featured at the World Gastro 2022 congress, showcasing its effectiveness in eradicating H. pylori across different BMI groups. Additionally, new findings on Opaganib's mechanisms and its significant mortality reduction in COVID-19 patients will be presented at the 2nd ARDS Drug Development Summit and ICEID conference. These data underscore RedHill's continued research focus on gastrointestinal and infectious diseases.
RedHill Biopharma (Nasdaq: RDHL) reported Q1 2022 net revenues of $18.2 million, down from $22.1 million in Q4 2021, attributed to cyclical Movantik sales trends. The company has implemented a cost reduction plan, expecting $50 million in savings over 18 months, which contributed to a 70% decrease in cash used in operations to $4 million. Talicia® and Movantik® showed strong growth, with prescription increases of 12.8% and 8.6% respectively. The company maintains a cash balance of $45 million and is in discussions for potential acquisitions and external funding for ongoing R&D initiatives.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its first quarter 2022 financial results on June 23, 2022, at 8:30 a.m. EDT. The company has invited investors to join a conference call, which will include key operational highlights. Interested participants can register and access the event through the company's website. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs like Movantik and Talicia, and is engaged in several late-stage clinical programs.
RedHill Biopharma presented new data analyses on Talicia during Digestive Diseases Week (DDW) 2022, focusing on its efficacy in treating H. pylori infection in patients with diabetes. Findings showed Talicia maintained eradication rates of 91.7% in diabetic patients versus 84.1% in non-diabetic patients. No significant antibiotic resistance was observed. A pharmacokinetic study indicated Talicia's low-dose rifabutin formulation achieves higher intragastric antibiotic exposure, crucial for effective treatment. Talicia addresses a significant unmet need as around 35% of U.S. adults are affected by H. pylori.
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.