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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) reported positive findings from a Phase 2/3 study of its oral drug opaganib in hospitalized COVID-19 patients. The analysis showed a 62% reduction in mortality among those treated compared to the placebo group. Key outcomes included 77% of opaganib patients reaching room air by Day 14 and a median discharge time of 10 days versus 14 days for placebo, suggesting significant clinical benefits. The company plans to discuss these results with regulators to determine future steps for opaganib as a potential treatment for severe COVID-19.
RedHill Biopharma (Nasdaq: RDHL) announced a settlement and license agreement with Aurobindo Pharma regarding the patent litigation for Movantik® (naloxegol). The agreement prevents Aurobindo from selling a generic version in the U.S. until April 1, 2031, pending FDA approval. RedHill acquired global rights to Movantik from AstraZeneca in April 2020, excluding Europe and Canada. The settlement concludes all ongoing Hatch-Waxman patent litigations against ANDA filers prior to patent expiration.
RedHill Biopharma (Nasdaq: RDHL) has announced preliminary top-line data from its 475-patient Phase 2/3 study of opaganib in hospitalized patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint, though trends indicated potential benefits of opaganib compared to placebo. Safety data showed good tolerability with a balance of adverse events. The findings suggest exploring opaganib's use in earlier disease stages. The company plans further discussions with regulators regarding next steps and ongoing studies.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for a Phase 2/3 study of RHB-107 (upamostat), aimed at treating non-hospitalized symptomatic COVID-19 patients. This approval comes as the U.S. study expands its site locations to enhance patient recruitment. RHB-107, an oral antiviral targeting serine proteases, shows promise against emerging viral variants with prior studies demonstrating clinical safety. Concurrently, opaganib is being evaluated in a global Phase 2/3 trial for severe COVID-19.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Phase 2/3 study of RHB-107 (upamostat), an oral treatment for symptomatic COVID-19 patients not requiring hospitalization. The study aims to assess the safety and efficacy of RHB-107, with expanded U.S. sites to boost patient recruitment. RHB-107 targets viral entry through human cell factors and shows promise against emerging variants. Concurrently, the company is awaiting top-line results from its opaganib study for severe COVID-19 cases.
RedHill Biopharma (Nasdaq: RDHL) announced promising results from a preclinical study demonstrating that opaganib (ABC294640) significantly decreases renal fibrosis in a model of kidney damage. This condition, which can lead to acute renal failure, poses risks especially for COVID-19 patients. The study highlights opaganib's potential as a therapeutic option for chronic kidney disease and acute kidney injury associated with COVID-19, potentially benefiting millions of patients. Key upcoming data from the global Phase 2/3 study will further evaluate its effectiveness in hospitalized COVID-19 patients.
RedHill Biopharma (NASDAQ:RDHL) presented three new analyses of Movantik (naloxegol) data at PAINWeek 2021, focusing on its efficacy in patients aged ≥65 and across varying opioid doses. The analyses showed Movantik's superior response rates compared to placebo, providing rapid relief from opioid-induced constipation (OIC). Data pooled from two Phase 3 studies involved 891 patients treated with Movantik and 446 in the placebo group. The findings underscore the importance of managing OIC, especially in older patients who frequently receive opioid therapy.
RedHill Biopharma (Nasdaq: RDHL) presented new analyses of Movantik (naloxegol) data at PAINWeek 2021, demonstrating its rapid efficacy for opioid-induced constipation (OIC) in patients aged 65 and older, along with all opioid doses. The pooled data from two Phase 3 studies involved 891 patients, indicating that Movantik significantly improves bowel movement rates compared to placebo. With a high prevalence of OIC among elderly opioid users, these findings underscore Movantik's role in pain management without added constipation issues, as emphasized by leading researchers.
RedHill Biopharma (NASDAQ: RDHL) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021, where Guy Goldberg, Chief Business Officer, will present. Additionally, RedHill will be featured in a fireside chat at the Cantor Global Healthcare Conference on September 30, 2021. Both events will be accessible via webcast on the company's website for 30 days post-event, underscoring RedHill's focus on advancing treatments for gastrointestinal and infectious diseases.
RedHill Biopharma (Nasdaq: RDHL), a specialty biopharmaceutical company, announces participation in two virtual conferences in September 2021. At the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Guy Goldberg, Chief Business Officer, will present. The Cantor Global Healthcare Conference will feature a fireside chat on September 30 with Goldberg. Webcasts will be accessible for 30 days on RedHill's Investors page. RedHill focuses on gastrointestinal and infectious diseases, with key products including Movantik®, Talicia®, and Aemcolo®.
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