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.
ObvioHealth has announced a hybrid clinical trial for COVID-19 treatment utilizing RedHill Biopharma's RHB-107 (upamostat). The Phase 2/3 study will monitor over 300 symptomatic COVID-19 patients remotely, assessing RHB-107's safety and efficacy. This innovative approach combines digital health technologies with home healthcare to enhance patient monitoring while minimizing hospital visits. RHB-107 is designed to combat emerging viral strains, offering a promising oral therapy option. The trial's unique setup fosters data collection while safeguarding participant health.
RedHill Biopharma Ltd. (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 $35 million. The offering, managed by H.C. Wainwright & Co., expects to close by March 4, 2021. RedHill will use the funds for clinical development, commercialization, acquisitions, and corporate purposes. An additional 656,250 ADSs may be purchased by the underwriter within 30 days. This offering follows a shelf registration statement effective since August 2019.
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.