Articles from RedHill Biopharma Ltd

Oral opaganib's reported potent in vitro activity against Omicron adds to previously observed inhibition of Delta and other SARS-CoV-2 variants of concern that cause COVID-19; Testing conducted by The University of Hong Kong School of Public Health, a world renowned WHO collaborating center Based on the new and previously announced data, opaganib's unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected

RALEIGH, NC and TEL-AVIV, ISRAEL / ACCESSWIRE / December 15, 2021 / RedHill Biopharma Ltd. (NASDAQRDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, Mr. Dror Ben-Asher, collectively purchased approximately an additional 66,000 American Depositary Shares (ADSs) of RedHill since mid-October, 2021, in

RedHill Biopharma: Concerning Rates of Clarithromycin Prescribing for H. pylori, Despite Increasing Antibiotic Resistance, Uncovered in New Digestive Diseases & Sciences Publication Despite increasing resistance to, and suboptimal H. pylori eradication rates with, clarithromycin, a new study, published in Digestive Diseases and Sciences, indicates that over 80% of all prescriptions for H. pylori infection contain clarithromycin In addition,

Unique Mode of Action Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron SARS-CoV-2 variant, as well as other variants of concern Regulatory update Opaganib global Phase 2/3 data packages submitted to European EMA, with initial feedback expected by end of year, to the U.S. FDA

RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI High Body Mass Index and obesity are known risk factors for H. Pylori eradication treatment failure; Newly published data in GastroHep shows high eradication rates for Talicia® across BMI groups Data from a post-hoc analysis showed H. pylori eradication rates with Talicia of 88.1% and 90.9% in patients with BMI> 30/<40kg/m2

RedHill Biopharma's Movantik® Added as Preferred and Unrestricted Brand To Major National Medicare Formulary Serving Millions of Americans Movantik® approved for inclusion as preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans as of January 1, 2022 - Movantik's total commercial coverage extends to 152 million American patients' lives and will grow to 46 million

RedHill Biopharma Reports Operational Highlights and Third Quarter 2021 Financial Results RedHill Accelerates its Two Advanced COVID-19 Pill Clinical Programs in Light of their Potential Against Omicron Acting independently of spike protein mutation, opaganib and RHB-107's unique host-targeted mechanisms of action hold potential versus Omicron and other variants Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality

RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose

RedHill received the first tranche of $5 million in a private placement of restricted stock priced at $6.04 per ADS, representing a 20% premium based on the 30 trading days' volume weighted average price (VWAP) ending on the effective date RedHill granted Kukbo a right of first offer for opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories Opaganib's COVID-19 data packages submission process is advancing in

Two new analyses evaluate pharmacological and clinical advantages of Talicia® as first-line H. pylori therapy over clarithromycin-based regimens - Two new analyses of Movantik® data evaluate efficacy in treating extreme opioid-induced constipation with severe symptoms - Talicia®, an FDA approved therapy, is designed to replace clarithromycin-based regimens as first-line H. pylori eradication therapy; ACG Guideline recommends

TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 18, 2021 / RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, CFO, Chief Commercial Officer, Chief Business Officer and Chief Corporate & Business Development Officer, collectively purchased approximately 180,000

RedHill Biopharma Announces New U.S. Patent Covering Talicia for H. pylori Infection Through 2034 The patent is directed to the Talicia® formulation and pharmaceutical kits for use in the treatment of H. pylori infection The new patent, valid through 2034, will be the fifth patent listed in the FDA Orange Book for Talicia Talicia is designed as a first-line option to address the high resistance of H. pylori bacteria to historical

RedHill Biopharma's Talicia® added to Medi-Cal Contract Drug List with No Prior Authorization Requirements Addition of Talicia® by Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization is an important expansion of coverage for California patients and continues to increase Talicia's overall unrestricted coverage Coverage commenced for two million patients in Medi-Cal's FFS plan on October 1st,

62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019) 21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal

RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care - Number of U.S. sites for the study has also been expanded - RHB-107,

COVID-19 and long COVID patients are at increased risk of developing kidney damage - Opaganib significantly decreased kidney fibrosis in a preclinical in vivo model - Renal fibrosis is a progressive process which occurs in patients with chronic kidney disease (CKD) and can ultimately lead to end-stage renal failure - Opaganib is a novel, late clinical-stage oral pill drug candidate with dual anti-inflammatory and antiviral activity and has

RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021 Two new analyses of Movantik® (naloxegol) data evaluated the safety and efficacy of Movantik in a subgroup of patients aged ≥ 65 years -- Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid

RedHill Biopharma to Present at H.C. Wainwright Annual Global Investment and Cantor Global Healthcare Conferences TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 2, 2021 / RedHill Biopharma Ltd. (NASDAQRDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September: H.C. Wainwright 23rd Annual Global Investment Conference (September

- Achieved record quarterly revenues of $21.5 million for Q2/2021, 4.5% increase from Q1/2021 despite challenging market conditions; Cash balance[1] of approximately $71.5 million as of June 30, 2021 - Record Talicia® quarterly prescription volume up more than 10%; Movantik® quarterly new prescriptions up 5.6%; Talicia and Movantik coverage expanded to 8 and 9 out of 10 commercially insured Americans, respectively - Opaganib in final

RedHill Biopharma's Opaganib Demonstrates Strong Inhibition of COVID-19 Delta Variant Opaganib demonstrated strong inhibition of COVID-19 Delta variant in a human bronchial epithelial cells model, adding to prior data demonstrating potent inhibition of all COVID-19 variants tested to date -- Opaganib's unique, host-targeted, dual antiviral and anti-inflammatory approach to combatting COVID-19 is expected to maintain effect against other

RedHill Biopharma Announces Two New U.S. Patents Covering Opaganib for Ebola Virus and RHB-104 for Crohn's U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035 - Opaganib's 475-patient global Phase 2/3 study in severe COVID-19 approaching completion with upcoming top-line results - Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs

RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Apotex TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 22, 2021 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ('AstraZeneca') and Nektar Therapeutics have entered into a settlement and license agreement with

RedHill Biopharma Significantly Extends Unrestricted Commercial Coverage for Talicia® with OptumRx Addition of Talicia® by OptumRx significantly extends Commercial patient access to Talicia® through this leader in U.S. healthcare Patient access to Talicia now extends to greater than 8 out of 10 covered U.S. Commercial lives Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as

RedHill Biopharma Announces Last Patient Out for Phase 2/3 COVID-19 Study of Oral Opaganib Patient follow-up completed for the 475-patient global Phase 2/3 study of oral opaganib for severe COVID-19 Top-line results expected in the coming weeks Opaganib, a novel, dual antiviral and anti-inflammatory investigational COVID-19 pill, demonstrated potent inhibition of Beta and Gamma variants and is expected to be effective against emerging