Welcome to our dedicated page for Redhill Biopharma Ltd. news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharma Ltd. stock.
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 an increase in its public offering to 4,375,000 American Depositary Shares (ADSs) at $8.00 per ADS, aiming for gross proceeds of approximately $35 million. Closing is expected on March 4, 2021. The underwriter, H.C. Wainwright & Co., has an option for an additional 656,250 ADSs. Proceeds will support clinical development, commercialization, acquisitions, and general corporate purposes. The offering is being made under a 'shelf' registration statement effective since August 2019.
RedHill Biopharma Ltd (Nasdaq: RDHL) announced a firm commitment underwriting agreement with H.C. Wainwright & Co. for the sale of 1,250,000 American Depositary Shares (ADSs) at $8.00 each, with gross proceeds expected to reach $10 million. The closing is anticipated on or around March 4, 2021, subject to customary conditions. Additionally, there is a 30-day option for the underwriter to purchase up to 187,500 additional ADSs. Proceeds will be used for clinical development, commercialization, and general corporate purposes.
RedHill Biopharma (Nasdaq: RDHL) announced the expansion of its global Phase 2/3 study for opaganib, targeting severe COVID-19, to the U.S. The move follows FDA recommendations after reviewing Phase 2 data. The study, with 464 patients planned across 8 countries, is over 50% enrolled and expected to provide top-line data in Q2 2021. Preliminary results indicate opaganib significantly reduced oxygen requirements and demonstrated a robust safety profile in its Phase 2 study. Opaganib, a novel oral SK2 inhibitor, shows promise against viral variants and additional oncological applications.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has entered into manufacturing agreements with Cosmo Pharmaceuticals NV to produce Movantik and RHB-204. Movantik is RedHill's top-selling drug in the U.S., designed to treat opioid-induced constipation. RHB-204 is in Phase 3 trials for pulmonary nontuberculous mycobacteria disease, showing significant market potential estimated at over $500 million. The partnership is aimed at enhancing supply chain capabilities and meeting increasing market demands.
RedHill Biopharma (Nasdaq: RDHL) announced new manufacturing agreements with Cosmo Pharmaceuticals for two products: Movantik® and RHB-204. Movantik is RedHill's top-selling product for treating opioid-induced constipation, which affects millions. RHB-204 is in Phase 3 trials as a treatment for pulmonary nontuberculous mycobacterial disease, with market potential exceeding $500 million. These agreements enhance RedHill's supply capabilities and support ongoing strategic collaboration with Cosmo.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has announced the dosing of its first patient in a U.S. Phase 2/3 study for RHB-107 (upamostat), aimed at treating symptomatic COVID-19 patients who do not require hospitalization. RHB-107, a potent serine protease inhibitor, demonstrated strong antiviral action against SARS-CoV-2 in preclinical studies. The trial includes 310 patients and utilizes innovative telemetry and home-based monitoring for safety and efficacy, intending to provide effective treatment against emerging viral variants.
On February 17, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the dosing of the first patient in its U.S. Phase 2/3 study of RHB-107 (upamostat), targeting symptomatic COVID-19 patients who do not require hospitalization. This investigational drug aims to inhibit viral entry by targeting serine proteases. The study will enroll 310 patients and utilizes innovative home monitoring to enhance safety. RedHill also advances its second COVID-19 candidate, opaganib, for hospitalized patients, with promising efficacy data already reported.
On February 9, 2021, RedHill Biopharma (Nasdaq: RDHL) announced its participation in two key virtual conferences: the SVB Leerink 10th Annual Global Healthcare Conference (Feb 22-26) and the BIO CEO & Investor Digital Conference (Feb 16-18). Dror Ben-Asher, CEO, will present on February 25, while Guy Goldberg, Chief Business Officer, will feature a session on-demand starting February 16. The presentations will be available for 30 days on RedHill's website. The company focuses on gastrointestinal and infectious diseases, with several late-stage clinical programs underway.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will present at two upcoming virtual conferences: the SVB Leerink 10th Annual Global Healthcare Conference from February 22-26, 2021, with a presentation by CEO Dror Ben-Asher on February 25, and the BIO CEO & Investor Digital Conference from February 16-18, 2021, featuring Guy Goldberg, Chief Business Officer. Webcasts will be available for 30 days on RedHill's website. The company focuses on gastrointestinal and infectious diseases, highlighting drugs like Movantik, Talicia, and Aemcolo.
RedHill Biopharma (Nasdaq: RDHL) announced a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib for severe COVID-19, based on a pre-scheduled review of efficacy and safety data. Opaganib has shown potential against viral resistance and has demonstrated improvements in reducing oxygen needs in patients. The study will expand to around 460 patients across 30 sites in 7 countries, with top-line data expected in Q2 2021 and potential emergency use applications.
FAQ
What is the current stock price of Redhill Biopharma Ltd. (RDHL)?
What is the market cap of Redhill Biopharma Ltd. (RDHL)?
What does RedHill Biopharma Ltd. specialize in?
What are RedHill's main commercial products?
What is Opaganib, and what are its potential uses?
What stage is RHB-107 currently in?
What recent achievements has RedHill Biopharma accomplished?
How is RedHill Biopharma's financial performance?
What is the strategic direction of RedHill Biopharma?
Who are RedHill Biopharma's development partners?
What is the significance of RedHill's new patents?
Where can more information about RedHill Biopharma be found?
