Welcome to our dedicated page for Redhill Biopharm news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharm stock.
RedHill Biopharma Ltd. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
RedHill Biopharma (Nasdaq: RDHL) presented a new Travelers' Diarrhea (TD) severity classification tool at Digestive Disease Week 2021, developed with the University of Texas School of Public Health. This tool aims to enhance clinical practice by providing clear separation of TD severity categories. The efficacy of Aemcolo (rifamycin) was confirmed through this tool, showing high effectiveness in moderate to severe TD cases. Aemcolo is noteworthy for its non-systemic delivery, resulting in limited side effects. This advancement could boost demand as travel resumes post-COVID.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will announce its first quarter 2021 financial results and operational highlights on May 27, 2021. A live webcast is scheduled for 8:30 a.m. EDT on the same day, allowing stakeholders to access key information, including performance metrics. RedHill focuses on gastrointestinal and infectious diseases, with products like Movantik, Talicia, and Aemcolo. Its ongoing clinical programs include RHB-204 for pulmonary NTM disease and opaganib for COVID-19 treatment.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a positive fourth review from the independent Data Safety Monitoring Board (DSMB) regarding its Phase 2/3 study of opaganib (Yeliva®) in hospitalized COVID-19 patients. The recommendation was based on safety data from 255 patients, enlarging the safety database to 380. The study is over 75% enrolled across 40 sites. Positive earlier Phase 2 data showed opaganib's effectiveness in reducing oxygen requirements without significant safety differences compared to placebo. Top-line results from the study are anticipated soon.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a settlement with MSN Pharmaceuticals regarding patent litigation for Movantik® (naloxegol). The agreement prohibits MSN from marketing a generic version in the U.S. until October 1, 2030, unless conditions allow earlier entry. RedHill acquired Movantik rights in April 2020 and aims to protect its interests in ongoing litigation against other ANDA filers. This settlement may impact RedHill's market position as it retains exclusivity for Movantik until the settlement date.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the compassionate use treatment of opaganib for COVID-19 pneumonia patients in Switzerland. This oral sphingosine kinase-2 inhibitor has shown anti-inflammatory and antiviral properties. The company recently reported positive Phase 2 data in the U.S. and is two-thirds enrolled in a global Phase 2/3 study involving 464 patients. Opaganib, which has shown potential against SARS-CoV-2, aims to address severe COVID-19 cases as well as other oncology and inflammatory conditions.
RedHill Biopharma reported 2020 financial results with net revenues of approximately $64 million, marking a significant increase of $58 million from 2019, driven by Movantik and Talicia sales. Gross profit stood at $27.5 million. Despite strong growth, the company faced an operating loss of approximately $64 million and a net loss of about $76 million. The company's cash balance was solid at $100 million as of March 2021. RedHill is progressing in COVID-19 therapeutics with two Phase 2/3 studies for Opaganib and RHB-107, expecting to achieve commercial operational breakeven by the end of 2021.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, during a conference call at 8:30 a.m. EDT. Highlights will include the company's full-year financial performance and ongoing clinical studies, particularly for COVID-19 treatments opaganib and RHB-107, as well as a Phase 3 study for RHB-204 targeting pulmonary nontuberculous mycobacteria disease.
The webcast will be available live on the company's website.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, at 8:30 a.m. EDT.
The company will detail 2020 financial performance, commercial activities, and updates on ongoing clinical studies for COVID-19 treatments (opaganib and RHB-107) and a Phase 3 study of RHB-204 for pulmonary nontuberculous mycobacteria.
The webcast will be available live on the company’s website and for replay for 30 days.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announces its participation in several virtual conferences throughout March 2021. Key events include:
- Sachs Spring Life Sciences Week (March 8-11) featuring Guy Goldberg, Chief Business Officer.
- Barclays Global Healthcare Conference (March 9-11) with CEO Dror Ben-Asher on March 11.
- H.C. Wainwright Global Life Sciences Conference (March 9-10) also with Guy Goldberg.
- 33rd Annual Roth Conference (March 15-17), presentation by Guy Goldberg.
- BIO-Europe Spring Digital Conference (March 22-25) with Adi Frish.
Webcasts will be available on RedHill's website for 30 days.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has completed a public offering of 4,375,000 American Depositary Shares (ADSs) at $8.00 each, raising gross proceeds of $35 million. The offering includes a 30-day option for the underwriter to purchase an additional 656,250 ADSs. The funds will support the company's clinical development, commercialization efforts, and general corporate purposes. H.C. Wainwright & Co. served as the book-running manager for the offering. This offering is part of a previously filed shelf registration with the SEC.