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RedHill Biopharma (RDHL) is accelerating its COVID-19 clinical programs for opaganib and RHB-107, showcasing their efficacy against the Omicron variant. A Phase 2/3 analysis revealed a 62% mortality reduction in moderately severe patients treated with opaganib. The company reported Q3 2021 net revenues of $21.6 million, with a gross margin increase to 57%. New strategic investments and a $15.5 million public offering bolster its financial position, while Talicia and Movantik continue to see prescription growth, with Talicia's revenue up 117% compared to Q3 2020.
On November 23, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the closing of an underwritten public offering of approximately 4.7 million American Depositary Shares (ADSs), raising about $15.5 million in gross proceeds. Each ADS represents ten ordinary shares and was offered by RedHill, which has granted a 30-day option to purchase approximately 0.7 million additional ADSs. The funds will support commercialization activities, clinical development programs, and general corporate purposes.
RedHill Biopharma (RDHL) has completed enrollment for Part A of its Phase 2/3 study of RHB-107 (upamostat), a once-daily oral treatment for symptomatic COVID-19 patients not requiring hospitalization. The study, conducted in the U.S. and South Africa, aims to evaluate safety, tolerability, and dose selection. Top-line results are expected in Q1 2022. RHB-107 targets human cell factors and aims to be effective against emerging variants. Concurrently, data packages for another COVID-19 drug, opaganib, have been submitted for regulatory review.
RedHill Biopharma (Nasdaq: RDHL) has presented new data analyses for Talicia and Movantik at the ACG 2021 Annual Scientific Meeting.
The Talicia analyses highlight the high utilization of clarithromycin despite resistance issues and suggest that Talicia's dosing leads to effective H. pylori eradication. The Movantik data demonstrate its efficacy in providing rapid relief from severe opioid-induced constipation.
These studies reinforce the competitive positioning of Talicia and Movantik in the market, addressing significant public health concerns.
RedHill Biopharma (Nasdaq: RDHL) announced the granting of U.S. Patent No. 11,135,172, which reinforces protection for Talicia, its FDA-approved treatment for H. pylori infection, extending patent life through 2034. This patent is part of an effort to bolster an international patent portfolio addressing antibiotic resistance concerns. Talicia, a fixed-dose capsule combining antibiotics and a proton pump inhibitor, showed an 84% eradication rate in pivotal studies. The company aims to list this patent in the FDA's Orange Book, enhancing Talicia's market exclusivity.
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 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 Ltd. (Nasdaq: RDHL) will report its second quarter 2021 financial results on August 26, 2021. A live webcast will commence at 8:30 a.m. EDT, featuring operational highlights. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs such as Movantik, Talicia, and Aemcolo. Key clinical developments include ongoing studies for therapies targeting pulmonary NTM disease and COVID-19. The company emphasizes the importance of its upcoming announcements, which could impact investor sentiment.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study showing that opaganib effectively inhibits the Beta and Gamma COVID-19 variants. This investigational oral drug targets sphingosine kinase-2 (SK2), crucial for viral replication. The global Phase 2/3 study of opaganib, fully enrolled with 475 patients, is nearing completion, with encouraging preliminary safety and efficacy data. Opaganib's dual mechanism combines antiviral and anti-inflammatory effects, showing potential against emerging COVID-19 variants.
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.
