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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 on December 7, 2020, that it has expanded the unrestricted national and regional commercial coverage for its drug Talicia® to over 40 million additional Americans, bringing total coverage to over 167 million. This expansion allows Talicia to reach over 70% of commercial lives and addresses high antibiotic resistance rates for H. pylori infections, which affect about 35% of the U.S. population. Talicia is a unique therapy that combines two antibiotics and a proton pump inhibitor, approved by the U.S. FDA in 2019.
RedHill Biopharma (Nasdaq: RDHL) announced partnerships with two U.S. manufacturers to scale up production of opaganib, an oral treatment for severe COVID-19 pneumonia, ahead of potential emergency use applications expected in Q1 2021. The company has also secured collaborations with European and Canadian manufacturers. Currently, a global Phase 2/3 study is over 50% enrolled, aiming for top-line data soon. Opaganib targets the SK2 enzyme, showing promise in reducing viral replication and lung inflammation, with additional studies for cancer treatment ongoing.
RedHill Biopharma (Nasdaq: RDHL) announced its participation in two virtual healthcare conferences in December 2020. The Evercore ISI 3rd Annual HealthCONx Conference is scheduled for December 3, featuring a fireside chat with CEO Dror Ben-Asher and COO Gilead Raday. Additionally, the Piper Sandler 32nd Annual Virtual Healthcare Conference will offer an on-demand fireside chat starting November 23. RedHill, focused on gastrointestinal and infectious diseases, is known for its drugs Movantik®, Talicia®, and Aemcolo® and ongoing late-stage clinical programs.
RedHill Biopharma (Nasdaq: RDHL) has initiated a Phase 3 study to evaluate RHB-204 for the treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex. This disease currently lacks an FDA-approved first-line therapy, with around 110,000 cases reported in the U.S. The study will enroll 125 patients across 40 sites, assessing safety and efficacy over 6 months, with potential continuation for 16 months. RHB-204 has received Orphan Drug and Qualified Infectious Disease Product designations, extending market exclusivity up to 12 years upon FDA approval.
RedHill Biopharma (RDHL) announced a unanimous recommendation from an independent Data and Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib in treating severe COVID-19 pneumonia. This recommendation follows a review of safety data from the first 70 patients treated over 14 days. The study, which is more than 50% enrolled with 270 patients, aims to provide efficacy data expected in Q1 2021. A companion U.S. Phase 2 study has completed enrollment. Opaganib holds promise due to its dual anti-inflammatory and antiviral properties.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that the U.S. FDA has cleared its IND application for RHB-107 (upamostat) to enter Phase 2/3 trials in patients with symptomatic COVID-19 who do not require hospitalization. This milestone aims to address COVID-19 treatment earlier in the disease course, using an oral therapy, which is significant given the large number of symptomatic patients at risk. The trial plans to enroll patients early next year, targeting recovery time and assessing safety alongside other endpoints.
RedHill Biopharma (Nasdaq: RDHL) has completed patient enrollment for its U.S. Phase 2 study of opaganib (Yeliva®) targeting severe COVID-19 pneumonia. This study, which is not powered for statistical significance, aims to evaluate safety and gather efficacy signals, with topline data expected soon. Concurrently, a global Phase 2/3 study is around 50% enrolled, with initial safety analysis anticipated shortly. Opaganib uniquely targets viral replication mechanisms, potentially minimizing resistance issues, and aims for emergency use applications based on positive outcomes.
RedHill Biopharma (Nasdaq: RDHL) announced that Chief Business Officer Guy Goldberg will present a corporate overview and participate in 1-on-1 investor meetings at the German Equity Forum 2020 on November 17, 2020, at 9:30 a.m. CET. The event is among Europe’s largest investor gatherings. A replay of the presentation will be available for 30 days on the Company's website. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs such as Movantik and Talicia.
RedHill Biopharma reported Q3 2020 net revenues of approximately $21 million with a gross profit of $10.6 million, representing a 51% gross margin, up from 32% in Q2 2020. Talicia® saw exceptional growth with a 300% quarter-over-quarter increase in prescriptions. Movantik® also reversed its declining trend with two consecutive quarters of prescription growth. The Company is advancing studies for opaganib in COVID-19, nearing 50% enrollment for global trials. As of September 30, 2020, RedHill's cash balance was approximately $51 million.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced it will report its third-quarter 2020 financial results on November 12, 2020. A conference call will be held at 8:30 a.m. EST, covering financial performance, commercial activities, and progress in its late-stage development program for opaganib targeting COVID-19, along with advancements in its pipeline, including the Phase 3 study for RHB-204 for pulmonary infections.
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