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 (Nasdaq: RDHL) presented new analyses on Talicia at the Obesity Week Annual Meeting (Nov 1-4, 2022). These analyses indicate that Talicia's efficacy for eradicating H. pylori is not affected by elevated body mass index (BMI) or diabetes. Notably, Talicia achieved an 84% eradication rate compared to 58% for standard therapies. This positions Talicia as a first-line treatment for H. pylori, crucial given that the infection affects ~35% of U.S. adults. Talicia offers a favorable safety profile and demonstrates high intragastric concentrations, supporting its broad applicability in diverse patient populations.
RedHill Biopharma (Nasdaq: RDHL) presented new data analyses for its products Talicia and Movantik at the ACG Annual Meeting on October 21-26, 2022. A PBPK modeling study revealed that Talicia, a leading H. pylori treatment, provides superior intragastric antibiotic exposure with a dosing regimen of 50 mg rifabutin every 8 hours compared to standard rifabutin therapies. Movantik, the top oral PAMORA for opioid-induced constipation, demonstrated significant improvements in patient quality of life and symptom control in pooled analyses of phase 3 studies. RedHill emphasizes Talicia's efficacy in addressing antibiotic resistance issues.
RedHill Biopharma (NASDAQ: RDHL) announced that the United States Patent and Trademark Office granted a new method of use patent for opaganib, aimed at treating COVID-19 pneumonia in patients requiring supplemental oxygen (FiO2 up to 60%). This patent protects findings from a Phase 2/3 study, which revealed a 62% reduction in mortality among treated patients. RedHill continues its development of opaganib, focusing on pivotal Phase 3 trial preparations and potential funding opportunities for pandemic preparedness.
RedHill Biopharma (Nasdaq: RDHL) announced on October 12, 2022, that it received a notification from Nasdaq regarding a minimum bid price deficiency. The Company’s American Depositary Shares have closed below the required $1.00 per share for 30 consecutive business days. RedHill has until April 10, 2023, to regain compliance by maintaining a bid price of $1.00 or more for at least ten consecutive business days. The company will continue trading on Nasdaq and is assessing options to meet the listing requirements without immediate operational impacts.
RedHill Biopharma announced that its investigational antivirals, RHB-107 (upamostat) and opaganib, demonstrated in vitro effectiveness against the COVID-19 Omicron BA.5 variant. The results support their broad-acting, host-directed mechanisms, crucial for pandemic preparedness. Both drugs are undergoing further development, including Phase 3 trial designs and securing funding. Opaganib has shown a 70% mortality reduction in hospitalized patients, while RHB-107 reported a 100% reduction in hospitalization for non-hospitalized patients. The company plans to advance these candidates pending regulatory approvals.
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.
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