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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 Ltd. (Nasdaq: RDHL) announced that OptumRx has added Talicia (omeprazole magnesium, amoxicillin, and rifabutin) to its unrestricted Commercial Formulary for H. pylori treatment, effective July 1, 2021. This inclusion significantly enhances patient access to Talicia, covering over 80% of U.S. Commercial lives. Talicia, the only FDA-approved rifabutin-based therapy for H. pylori, addresses antibiotic resistance issues. The company maintains eight years of U.S. market exclusivity for Talicia under its Qualified Infectious Disease Product designation.
RedHill Biopharma has announced the completion of follow-up for its global Phase 2/3 study of oral opaganib in severe COVID-19 patients, with results expected soon. The study involved 475 patients and examined the drug's efficacy against variants like Beta and Gamma. Opaganib is a dual antiviral and anti-inflammatory drug, potentially effective against new variants. Independent safety reviews have been positive, and the company is in discussions with regulatory bodies for approval pathways.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the completion of treatment and follow-up for its 475-patient global Phase 2/3 study of opaganib (ABC294640) in hospitalized COVID-19 pneumonia patients. Top-line results are expected soon. Opaganib demonstrated strong in vitro activity against COVID-19 variants and has received positive Phase 2 efficacy data. The primary endpoint focuses on patients breathing room air without oxygen support by Day 14. The company is in discussions with regulatory bodies for approval pathways and potential partnerships.
RedHill Biopharma (Nasdaq: RDHL) announced that Movantik® (naloxegol) has been added as an unrestricted preferred brand to a major national commercial formulary, effective July 1, 2021. This inclusion means over 30 million more Americans will gain access to Movantik, which treats opioid-induced constipation. Nearly 90% of U.S. commercial lives are now covered. Movantik's effectiveness and importance for pain management are emphasized, with ongoing efforts to expand formularies further. The safety information highlights potential gastrointestinal risks associated with Movantik usage.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study showing that opaganib effectively inhibits the Beta and Gamma COVID-19 variants. This investigational oral drug targets sphingosine kinase-2 (SK2), crucial for viral replication. The global Phase 2/3 study of opaganib, fully enrolled with 475 patients, is nearing completion, with encouraging preliminary safety and efficacy data. Opaganib's dual mechanism combines antiviral and anti-inflammatory effects, showing potential against emerging COVID-19 variants.
RedHill Biopharma (RDHL) announced positive Phase 2 data for oral opaganib (Yeliva®) in hospitalized COVID-19 patients at the World Microbe Forum. In a 40-patient study, 50% of opaganib recipients reached room air by Day 14, compared to 22% for placebo. Additionally, 86.4% of opaganib patients were discharged by Day 14 versus 55.6% for placebo. Median discharge time was 6 days for opaganib versus 7.5 days for placebo. No significant safety issues were noted. Following the completion of a 475-patient global Phase 2/3 study, further data is expected soon.
RedHill Biopharma (Nasdaq: RDHL) announced that Adi Frish, Chief Corporate & Business Development Officer, will present a corporate overview at the BIO Digital International Convention from June 14-18, 2021. The presentation will be accessible on the company’s website for 30 days post-conference. RedHill specializes in treatments for gastrointestinal and infectious diseases, including Movantik®, Talicia®, and Aemcolo®. Key clinical programs include RHB-204 for pulmonary NTM disease and others targeting COVID-19 and cancers. More at redhillbio.com.
RedHill Biopharma (Nasdaq: RDHL) announced the completion of patient enrollment in its global Phase 2/3 study of opaganib (Yeliva®, ABC294640) for treating severe COVID-19 pneumonia, exceeding its target with 475 randomized patients. The study's primary endpoint aims to assess the proportion of patients breathing independently by Day 14. Preliminary data suggests encouraging intubation and mortality rates compared to larger studies. Ongoing discussions with regulatory authorities and potential partners are underway to evaluate the next steps for opaganib's market introduction.
RedHill Biopharma reported Q1 2021 financial results with net revenues of approximately $20.6 million, down $0.9 million from Q4 2020. Gross profit decreased slightly to $10.3 million, maintaining a 50% gross margin. R&D expenses rose to $7.5 million due to COVID-19 programs. Operating loss was $18.2 million, while net loss totaled $22.9 million. Cash balance stood at $92.1 million. The company highlighted progress in COVID-19 programs with Opaganib nearly fully enrolled in a Phase 2/3 study.
RedHill Biopharma (Nasdaq: RDHL) announced receipt of two Notices of Allowance from the USPTO for patents covering its COVID-19 treatments, opaganib and RHB-107, extending protection until at least 2041. Both oral therapies target viral replication and are expected to be effective against emerging variants. Recruitment for opaganib's Phase 2/3 study is nearly complete, while RHB-107's study is ongoing. The company is assessing regulatory paths for opaganib, focusing on countries severely affected by COVID-19, pending positive study data. The strength of safety and efficacy data is crucial for regulatory submissions.
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