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RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company centered on gastrointestinal and infectious diseases. The company is headquartered in Israel and operates internationally, with teams in the U.S., Canada, and Europe. RedHill's primary focus is the development and commercialization of late-stage clinical therapeutics and patented reformulations of existing drugs.
Core Business and Products
RedHill's flagship commercial products in the U.S. include Talicia® (omeprazole, amoxicillin, and rifabutin) for treating Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® (rifamycin) for treating travelers' diarrhea. Talicia® is unique as the only FDA-approved rifabutin-containing therapy optimized for H. pylori eradication, addressing the rising concern of antibiotic resistance.
Key Development Programs
- Opaganib (ABC294640): A first-in-class oral SPHK2 inhibitor with applications in pandemic preparedness, oncology, and radioprotection. It is undergoing trials for multiple indications including Acute Radiation Syndrome (ARS) and COVID-19, and has shown promising results in pre-clinical studies against Ebola.
- RHB-107 (upamostat): An oral broad-acting, host-directed serine protease inhibitor targeting non-hospitalized symptomatic COVID-19, supported by U.S. Department of Defense funding in a 300-patient Phase 2 trial. It also shows potential for cancer and inflammatory gastrointestinal diseases.
- RHB-102: A novel therapy for chemotherapy and radiotherapy-induced nausea and vomiting, with positive Phase 3 results for acute gastroenteritis.
- RHB-104: Demonstrated efficacy in a Phase 3 study for Crohn's disease.
- RHB-204: In Phase 3 development for pulmonary nontuberculous mycobacteria (NTM) disease.
Recent Achievements
Recent publications highlight Opaganib's efficacy in enhancing long-term survival in radiation exposure models, and its selection by the U.S. NIH for the Radiation and Nuclear Countermeasures Program. Additionally, the company secured a new U.S. patent for Talicia®, extending its protection until 2034, and obtained a new Chinese patent for Opaganib in combination with immune checkpoint inhibitors, valid through 2040.
Financial Performance
For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million, primarily from Talicia®, with a gross profit of $3.1 million. The company has reduced its liabilities significantly following the divestiture of Movantik, and its financial health is bolstered by ongoing U.S. government funding for key R&D programs.
Strategic Direction
RedHill is focused on leveraging its solid pipeline and partnerships to address unmet medical needs in gastrointestinal and infectious diseases. The company is strategically positioned to benefit from growing geopolitical and health threats, aiming to provide innovative solutions in challenging healthcare environments.
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.
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.
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