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) has successfully closed an underwritten public offering, generating approximately $8.0 million in gross proceeds. The offering comprised 32 million units, each priced at $0.25, including one American Depositary Share (ADS) and one warrant to purchase another ADS. The funds will be allocated for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. served as the sole book-running manager for this offering.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a public offering priced at approximately $8.0 million, consisting of 32 million units of American Depositary Shares (ADS) and associated warrants at a price of $0.25 per ADS. The offering is set to close on December 6, 2022, subject to customary conditions. The net proceeds will be used for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is the book-running manager for this offering, conducted under a shelf registration statement declared effective by the SEC.
RedHill Biopharma (Nasdaq: RDHL) announced a proposed underwritten public offering of American Depositary Shares (ADSs) and warrants to purchase ADSs. The Company plans to use net proceeds for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is acting as the sole book-running manager. The offering is subject to market conditions and is detailed in a shelf registration statement declared effective by the SEC.
RedHill Biopharma Ltd. (RDHL) has reached a non-binding agreement to sell Movantik to HCR, eliminating its debt obligations. For Q3 2022, RedHill reported net revenues of $17.6 million, a decrease from the previous quarter, with an operating loss of $7.1 million. Prescription growth for Talicia and Movantik stood at 65% and 6.7% year-to-date, respectively. The company has ongoing discussions about opaganib for nuclear radiation injury and COVID-19, while RHB-204 received EU orphan drug status. Cash balance as of September 30, 2022, was $31.4 million.
RedHill Biopharma announced positive preclinical results for opaganib, demonstrating its potential in protecting hematological and kidney functions post total body irradiation (TBI). These findings align with U.S. government-funded data supporting opaganib as a therapeutic for nuclear radiation injuries. The development plan may leverage the Animal Rule, allowing for potential expedited approval without human efficacy studies. Discussions for governmental support are ongoing, while opaganib's further development for COVID-19 and oncology continues, highlighting its versatile pipeline potential.
RedHill Biopharma (Nasdaq: RDHL) has announced accelerated development for opaganib as a potential therapeutic against nuclear radiation injury and for cancer radiotherapy. Recent studies published in the International Journal of Molecular Sciences indicate opaganib may protect normal tissue from radiation damage and enhance survival in irradiated subjects. The drug is an oral, stable, small molecule with a shelf-life exceeding five years, making it suitable for government stockpiling. Development plans include following the Animal Rule for FDA approval and discussions for government support are already underway.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a non-binding agreement with HCR Collateral Management to transfer its rights in Movantik® (naloxegol) in exchange for cancelling all debt obligations under a Credit Agreement with HCR. RedHill will retain pre-closing liabilities related to Movantik while HCR will assume post-closing liabilities. The definitive agreements are expected to be signed soon, with closing anticipated by year-end, though certainty in completion remains uncertain. The agreement aims to ensure continuity in patient care during the transition.
RedHill Biopharma reported Q2 2022 net revenues of $18.3 million with an operating loss of $9.2 million. As of June 30, 2022, the cash balance stood at $43.2 million. Q3 2022 estimates project revenues between $16.5 million and $18.5 million, with losses between $5.5 million and $7.5 million. Prescription growth continues for Talicia® and Movantik®, with Talicia becoming the most prescribed H. pylori therapy. Ongoing negotiations regarding loan repayments and potential asset sales mark efforts to improve financial standing.
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.
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?
