RedHill plans to submit UK MAA 1 for Talicia for H. pylori infection, using MHRA's 2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG 3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori... Read More

The planned innovative Phase 2 study of RHB-204 1 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP 2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative... Read More

Guy Goldberg , RedHill's Chief Business Officer, presents today a business update at the European Life Sciences CEO Forum The update covers: The recent out-licensing of RHB-102 [1] to Hyloris (Euronext Brussels: HYL) in a potential $60 million plus royalties deal Initiation of the Bayer-funded Phase 2 clinical study of opaganib [2] in combination with Bayer's (ETR: BAYN) darolutamide in advanced prostate cancer Status of the... Read More

Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda ® ) across all indications and territories outside the United States , Canada and Mexico Recent positive UK MHRA advice provided a clear pathway for a UK Marketing Authorization Application (MAA). If... Read More

The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis The study is being financially supported by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor... Read More

Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H.... Read More

Heightened geopolitical tensions and Homeland Security concerns call for the development of potential therapies that can be quickly and easily mobilized in the event of a mass casualty nuclear or radiological incident There are currently no known approved therapies for gastrointestinal acute radiation syndrome (GI-ARS) Positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the... Read More

RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the agreements TEL-AVIV, Israel and RALEIGH, N.C. , Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma... Read More

RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the... Read More

The collaboration outlines plans for multiple in vivo studies, designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury. The collaboration aims to determine whether opaganib can advance into further definitive U.S. government-sponsored development under the FDA's Animal Rule pathway to approval Used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is... Read More

The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV) The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential approval as an MCM for EBOV Recent U.S. Army-funded studies showed that opaganib delivered a... Read More

Medi-Cal, California's Medicaid healthcare program, and RedHill have renewed their contract to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay – a major benefit for approximately fifteen million Californian Medi-Cal patients The renewed terms reflect both parties' ongoing commitment to improving patient access and outcomes,... Read More

New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO 2 )) prognostic for potential opaganib efficacy in treating COVID-19, valid through 204 Published post-hoc data from opaganib's Phase2/3 study showed that patients with ≤60% FiO 2 levels had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134), including:... Read More

First new American College of Gastroenterology (ACG) Clinical Guideline [1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing Talicia is the leading branded first-line therapy... Read More

TEL AVIV, Israel and RALEIGH, N.C. , Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the "Listings Qualifications Department") that the Company had regained compliance with the minimum bid price requirement under... Read More

Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients... Read More

A transformed RedHill : Numerous potential catalysts Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S.... Read More

Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths [1],[2] Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and... Read More

RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE) The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales Talicia is the leading... Read More

The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 [1] – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic ® and Wegovy ® and Eli Lilly's Trulicity ® and Mounjaro ® and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance ® Positive results from multiple in vivo studies show the impact of sphingosine... Read More

TEL AVIV, Israel and RALEIGH, N.C. , Aug. 16, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it plans to implement a ratio change of the Company's American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing four hundred (400) ordinary shares to a new ratio of one (1)... Read More

Newly published in the peer-reviewed journal Antibiotics, the 331-patient Phase 3 Crohn's disease study data shows the primary endpoint of clinical remission at week 26 was achieved, with high statistical significance, in 36.7% (61/166) of orally administered RHB-104 plus standard of care (SoC) patients, compared to 22.4% (37/165) of placebo plus SoC patients (p=0.0048); Safety profile similar to placebo. Study conducted... Read More

TEL-AVIV, Israel and RALEIGH, NC , July 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement"). As a result of the Agreement, RedHill received approximately $9.9 million in cash and gained full... Read More

TEL-AVIV, Israel and RALEIGH, NC , July 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd. ("Cosmo") to voluntary terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea (the "License Agreement"). The License Agreement, initially dated... Read More

New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response[1]. Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications[2] through 2040 ICIs have become a cornerstone in cancer treatment, having been hailed as a... Read More

The new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) is valid through 2035 and adds to opaganib's strong global intellectual property portfolio across multiple indications U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant... Read More

First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat) 1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense The study is expected to be completed by the end of 2024 RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked... Read More

RedHill continues corporate transformation to focus on U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base Focused externally funded R&D: Opaganib for nuclear and chemical medical countermeasure (NIH funding): Selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. Nuclear and... Read More

TEL AVIV, Israel and RALEIGH, N.C. , April 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into definitive agreements with private investors for the purchase and sale, at a premium, of 2,144,487 of the Company's American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares,... Read More

U.S. Patent and Trademark Office (USPTO) issues new patent covering Talicia 1 as an all-in-one treatment of Helicobacter pylori (H. pylori), supporting Talicia protection until February 12, 2034 This new patent adds to the existing strong intellectual property portfolio protecting Talicia, including composition of matter and other patents and FDA-granted data exclusivities granted under the GAIN QIDP designation and section... Read More

The U.S. government's Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by ASPR/BARDA and NIH/NIAID, in collaboration with Battelle [1] , have selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure Opaganib, a novel oral small molecule, is the first sphingosine kinase-2 (SPHK2) inhibitor... Read More

The data, published in the International Journal of Molecular Sciences, demonstrate that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism for the treatment of radiation-induced inflammation Opaganib, a novel oral, small... Read More

TEL AVIV , Israel and RALEIGH, N.C. , Jan. 26, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has closed its previously announced registered direct offering for the purchase and sale of 10,000,000 of the Company's American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares, at a purchase... Read More

TEL AVIV, Israel and RALEIGH, N.C. , Jan. 25, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 10,000,000 of the Company's American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares, at a... Read More

USPTO issues new patent covering Talicia [1] as a method for eradicating H. pylori regardless of patient Body Mass Index (BMI) [2] , supporting Talicia protection until May 2042 The patent is supported by previously published pooled data from two Phase 3 studies showing Talicia's efficacy was unaffected by presence of elevated BMI [3] The U.S. FDA recently granted five years' market exclusivity for Talicia under the... Read More

Investigational drugs opaganib and RHB-107 (upamostat) demonstrate distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a new U.S. Army-funded and conducted in vitro Ebola virus study Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs that are easy to administer and distribute, with demonstrated... Read More

TEL AVIV, ISRAEL and RALEIGH, N.C. , Dec. 12, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing, and is now compliant with... Read More

The new non-dilutive external funding, additional to the previously announced U.S. Government non-dilutive funding, now covers the entirety of the RHB-107 (upamostat) [1] arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment This additional funding amounts to approximately $4.8M directed towards evaluation of RHB-107 in the PROTECT study In addition to the platform's Master Protocol, the... Read More

The U.S. FDA has granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, as recommended by the FDA Exclusivity Board This grant is on top of three years' exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034 Talicia is the... Read More

TEL AVIV, Israel & RALEIGH, N.C. , Nov. 14, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received approval from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") to transfer the listing of the American Depositary Shares ("ADSs") to the Nasdaq Capital Market. The ADSs will be transferred... Read More

Novel, oral opaganib, delivered a statistically significant increase in survival time (at 150 mg/kg BID) in a U.S. Army-funded in vivo Ebola virus study Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having previously shown in vitro benefit in several strains of Ebola virus disease models Twice daily administered opaganib has previously demonstrated antiviral benefit in... Read More

TEL AVIV, Israel & RALEIGH, N.C. , Sept. 22, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that on September 19, 2023 , it received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, for the thirty consecutive business days from August 7, 2023 , to September 18, 2023 ,... Read More

FDA approves supplemental new drug application (sNDA) for Talicia, changing dosing to a simplified three times daily (TID) regimen, which may support increased patient adherence and treatment outcomes Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists [1] for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population [2] RALEIGH, N.C. and... Read More

USPTO issues Notice of Allowance for a new opaganib patent covering sphingosine kinase 2 inhibition treatment for Ebola virus disease, supporting opaganib protection until October 2035 Additionally, European Patent Office grants new RHB-102 patent covering ondansetron extended-release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms, providing protection of RHB-102 across multiple indications... Read More

RHB-107 included in the U.S. Department of Defense-supported ACESO PROTECT multinational platform trial for early COVID-19 outpatient treatment; The 300-patient Phase 2 study received FDA clearance and is estimated to be completed by the end of 2024 Opaganib awarded a further $1.7 million in U.S. government medical countermeasure (MCM) development funding – additional to the multimillion dollar-valued National Institutes of... Read More

RedHill's partner, Gaelan Medical, part of the Ghassan Aboud Group (GAG), receives marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia Gaelen placed a meaningful initial Talicia order and commences commercialization activities Talicia, a novel rifabutin-containing all-in-one oral capsule specifically designed to treat H. pylori, is the leading branded first-line therapy prescribed by U.S.... Read More

RHB-107 (upamostat) accepted for inclusion in ACESO's PROTECT adaptive platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand , Ivory Coast and South Africa The substantial 300-patient Phase 2 study, predominantly funded by the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has received FDA... Read More

TEL AVIV, ISRAEL , and RALEIGH, N.C. , July 25, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has closed its previously announced registered direct offering for the purchase and sale of 1,301,923 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary... Read More

TEL AVIV, ISRAEL & RALEIGH, N.C. , July 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 1,301,923 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary... Read More

Opaganib awarded a further $1.7 million in U.S. Government funding for development as a medical countermeasure for gastrointestinal acute radiation syndrome (ARS) The Small Business Innovation Research (SBIR) grant, given to RedHill's development partner, Apogee, is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development... Read More

Q1/23 Talicia net revenues of $3.4 million ; Cash balance of $28.8 million as of March 31, 2023 [1] ; Extinguishment of all debt obligations in exchange for the transfer of rights in Movantik ® [2] resulting in net income of $50.2 million for the first quarter of 2023 Opaganib selected by National Institutes of Health for Acute Radiation Syndrome development support contract; RHB-107 outpatient COVID-19 development... Read More

RedHill has elected to terminate RHB-204's U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to low accrual rate and plans to shift resources to more rapidly advance RHB-107 late-stage development for outpatient treatment of COVID-19 RedHill's advanced pipeline also includes: Opaganib – in collaboration with the U.S. Government's Radiation and Nuclear Countermeasures Program for development as a... Read More

TEL AVIV, Israel and RALEIGH, N.C. , May 15, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") dated May 9, 2023 indicating that the Company is not in compliance with the minimum Market Value of Publicly Held Shares... Read More

New Talicia PBPK modeling data, published in AP&T Journal, showed that generically substituted regimens are non-bioequivalent to Talicia Separately, new Talicia PBPK modeling data, presented at DDW, supports bioequivalence between TID and Q8H dosing regimens for H. pylori eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy These new data support Talicia's place as the leading... Read More

European Patent Office grants RHB-102 patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV), providing protection of RHB-102 to March 2034 Discussions with potential commercialization partners for RHB-102 in the UK and other territories are ongoing US PTO grants new opaganib combination compositions patent for treatment of cancer TEL AVIV, Israel and RALEIGH,... Read More

Having extinguished all debt and significantly reduced cost-base, RedHill is now focused on late-stage pipeline advancement, in collaboration with U.S. and other governments, commercial growth and revenue-generating product acquisition opportunities Opaganib selected by NIH's Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS) testing; FDA guidance provided on opaganib Animal Rule... Read More

TEL AVIV, Israel & RALEIGH, N.C. , April 11, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing, and is now compliant with... Read More

TEL AVIV, Israel and RALEIGH, N.C. , April 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd . (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has closed its previously announced registered direct offering for the purchase and sale of 1,500,000 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary... Read More

TEL AVIV, Israel and RALEIGH, N.C. , March 30, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement for the purchase and sale of 1,500,000 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, series A warrants... Read More

RedHill commits to reimburse out-of-pocket costs for Talicia patients that complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing - warranty commitment extends to all commercially insured or non-insured Talicia patients[1] Talicia warranty program believed to be the first of its kind offered for a widespread community (non-hospital) treated condition,... Read More

TEL AVIV, Israel and RALEIGH, NC , March 16, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it plans to implement a ratio change of the Company's American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing ten (10) ordinary shares to a new ratio of one (1) ADS... Read More

TEL AVIV, Israel and RALEIGH, NC , March 8, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced agreement, with a single investor, for the issuance of convertible promissory note in the principal amount of up to $6 million , convertible into American Depositary Shares ("ADS") and warrants to purchase ADSs of the Company, pursuant to... Read More

The National Institutes of Health's (NIH) Radiation and Nuclear Countermeasures Program (RNCP) has selected opaganib for testing via their radiation medical countermeasures Product Development Support contract as a potential treatment for Acute Radiation Syndrome (ARS) The RNCP is tasked with accelerating development of medical countermeasures for radiation injuries resulting from exposure during a radiological or nuclear... Read More

UK MHRA scientific advice meeting deems RHB-102 (BEKINDA ® ) data supportive of submission for approval for chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV) RHB-102 UK Marketing Authorisation Application (MAA) submission planned for 2H/23 If approved for marketing by the MHRA, RHB-102 could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of... Read More

RedHill Announces Positive MHRA Meeting and Planned UK Marketing Authorisation Application of RHB-102 (BEKINDA ® ) for Oncology Support UK MHRA scientific advice meeting deems RHB-102 (BEKINDA ® ) data supportive of submission for approval for chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV) RHB-102 UK Marketing Authorisation Application (MAA) submission planned for 2H/23 If approved for marketing by the... Read More

FDA provided guidance on opaganib's regulatory pathway under the Animal Rule for Acute Radiation Syndrome (ARS) The FDA's Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible Opaganib is an oral, novel, highly stable, small molecule pill with a five-year shelf life that is potentially suitable, if approved, for... Read More

TEL AVIV, Israel and RALEIGH, N.C , Feb. 6, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HCR dated... Read More

Once issued, the patent is expected to extend protection of RHB-204 to 2041 RHB-204 is currently undergoing a Phase 3 study in the U.S. as the first stand-alone standard of care first-line drug candidate for Non-tuberculosis Mycobacteria (NTM) disease caused by MAC infection RHB-204 has received U.S. FDA Fast Track, Orphan and QIDP priority designations as well as EMA Orphan Drug designation, providing eligibility for 12... Read More

Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed International Journal of Infectious Diseases RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms (median of 3 days to recovery vs. 8 days with placebo) and 100% reduction in... Read More

TEL AVIV, Israel and RALEIGH, N.C. , Dec. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 32,000,000... Read More

TEL AVIV, Israel , and RALEIGH, N.C. , Dec. 2, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $8.0 million , before deducting underwriting discounts and other expenses payable by the Company. The offering consists of... Read More

TEL AVIV, Israel and RALEIGH, N.C. , Dec. 1, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it intends to offer and sell, subject to market and other conditions American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase ADSs (the "Warrants") in an underwritten public offering. Each... Read More

Non-binding agreement in principle reached with HCR on sale of Movantik to extinguish all debt obligations, to facilitate growth Q3/22 Net revenues of $17.6 million ; Operating loss of $7.1 million ; Q3/22 positive cash flow from U.S. commercial operations, before interest payments [1] ; Cash balance [2] of $31.4 million as of September 30, 2022 Talicia ® and Movantik ® have delivered year-to-date prescription growth of 65%... Read More

Positive in vivo results from a new study of opaganib in radiation-induced hematologic and renal toxicity reaffirms opaganib's potential protective impact on hematological and kidney function following total body irradiation (TBI) These new preclinical results are consistent with recently published, U.S. government funded, in vivo efficacy data suggestive of opaganib's potential as a nuclear radiation injury therapeutic for... Read More

Physiologically-Based Pharmacokinetic (PBPK) modeling study of Talicia evaluated intragastric antibiotic exposure, critical for successful H. pylori eradication, comparing low-dose rifabutin 50 mg every 8 hours to generic rifabutin triple therapy 150mg twice a day or 300 mg once a day. Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, is intended for empiric first-line eradication of H.... Read More

USPTO grants new method of use patent for the inhibition of a disease caused by a coronavirus in patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60% Previous variant-agnostic efficacy data for opaganib, an investigational new drug for COVID-19 disease and several other viral diseases, highlights its promising profile as a broad acting, host-directed... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces that on October 12, 2022 , it received a letter from the Listings Qualifications Department of the Nasdaq Stock Market LLC ("Nasdaq") indicating that, for the last thirty consecutive business days, the bid price for the Company's American Depositary Shares ("ADSs") had closed below the minimum $1.00 per share... Read More

Novel, oral, host-targeted, broad-acting antivirals, once-daily RHB-107 (upamostat) and twice-daily opaganib, demonstrated in vitro inhibition of the COVID-19-causing SARS-Cov-2 Omicron BA.5 sub-variant in testing conducted by University of Tennessee Health Sciences Center Results add to previous variant-agnostic efficacy data for both investigational drugs against COVID-19 disease and several other viral diseases,... Read More

Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S. EMA Orphan Drug Designation provides eligibility for 10 years post-approval EU market exclusivity. U.S. FDA Fast Track, Orphan and QIDP priority designations, previously granted to RHB-204, extend U.S. post-approval market... Read More

Talicia ® - World Gastro 2022 congress ( August 17-18 ) : RedHill invited to give prestigious oral presentation of important data detailing high eradication rates across body mass index (BMI) groups with Talicia, the U.S.'s leading brand for Helicobacter pylori (H. pylori) eradication treatment - invitation sent to researchers with significant recently published clinical findings Opaganib for COVID-19 – Suggested... Read More

Targeting positive cash from operations to start during H2/22 [1] Focus on earlier achievement of operational profitability thanks to a recently implemented comprehensive cost reduction plan, with expected operational cost savings of approximately $50 million over the next 18 months Continuous implementation of disciplined cost controls reduced Q1/22 cash used in operating activities by more than 70% to approximately $4... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2022 financial results and operational highlights on Thursday, June 23, 2022 . The Company will host a conference call and webcast on Thursday, June 23, 2022 , at 8:30 a.m. EDT , during which it will present key highlights for the first quarter of 2022. The webcast... Read More

Talicia's efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradication therapy Physiologically based pharmacokinetic modeling study of Talicia evaluated intragastric antibiotic exposure, which is critical for successful H. pylori eradication, by comparing... Read More

RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement with a single leading healthcare investor for the purchase and sale of 10,563,380 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing ten (10) ordinary shares, at a purchase price of $1.42 per ADS (or ADS... Read More

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... Read More

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... Read More

RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its operational highlights and financial results for the fourth quarter and full year ended December 31, 2021 . Dror Ben-Asher , RedHill's Chief Executive Officer, said: "In 2021, RedHill's team delivered record revenues against a pandemic backdrop, overall contribution of commercial operations to the... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib [1] for the treatment of COVID-19, in South Korea . Under the terms of the license agreement, which follows the previously announced strategic investment by... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its fourth quarter and full year 2021 financial results and operational highlights on Thursday, March 17, 2022 . The Company will host a conference call and webcast on Thursday, March 17, 2022 , at 8:30 a.m. EDT , during which it will present key highlights for the fourth quarter and... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive top-line results from the Phase 2 part of the Phase 2/3 study of once-daily oral RHB-107 (upamostat) [1] in non-hospitalized symptomatic COVID-19 patients, predominantly conducted in the U.S. (60/61 patients) as well as South Africa . Although not powered for efficacy assessment, the study... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today provided a business update for the fourth quarter of 2021, including certain estimated unaudited preliminary financial data. Dror Ben-Asher , RedHill's Chief Executive Officer, said: "Strong sales growth momentum in the face of the persistent pandemic environment, coupled with strengthening our salesforce through... Read More

RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results from two recently completed prespecified analyses from the oral opaganib (ABC294640) [1] Phase 2/3 study in hospitalized severe COVID-19. The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available... Read More

In a prespecified analysis of all Phase 2/3 study patients with positive PCR at screening, opaganib improved the median time to viral RNA clearance by at least 4 days; Median of 10 days for viral clearance in the opaganib arm vs. clearance median not reached by end of 14-day treatment in placebo arm (Hazard Ratio 1.34; nominal... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) [1] , an H. pylori therapy, in the United Arab Emirates (UAE). Under the terms of... Read More

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, Mr. Dror Ben-Asher , collectively purchased approximately an additional 66,000 American Depositary Shares (ADSs) of RedHill since mid-October, in open-market transactions. About RedHill Biopharma RedHill... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication in the journal Digestive Diseases and Sciences of a new study entitled " Pitfalls of Physician-Directed Treatment of Helicobacter pylori : Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data ", revealing concerning rates of widespread, physician-directed prescribing... Read More

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... Read More

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... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces the publication of a new study entitled " Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep , showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical... Read More

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>... Read More

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... Read More

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 in moderately severe hospitalized patients; Data packages submitted in... Read More

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%... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021 . The Company will host a webcast on Tuesday, November 30, 2021 , at 8:30 a.m. EST , during which it will present key highlights for the third quarter of 2021. The webcast including... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of the previously announced underwritten public offering of approximately 4.7 million American Depositary Shares ("ADSs") for gross proceeds of approximately $15.5 million , before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill.... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million , before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced an underwritten public offering of American Depositary Shares ("ADSs"). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an... Read More

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 selection, expected in Q1/ 22 RHB-107... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg , RedHill's Chief Business Officer, will present an overview of the Company and host 1-on-1 investor meetings at the following virtual conferences in November: H.C. Wainwright 7 th Annual Israel Conference - November 15, 2021 Presentation: Monday, November 15, 2021 , at 8:00 a.m.... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a strategic agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for the sale of RedHill's American Depositary Shares ("ADSs") in a private... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the presentation of four new analyses of Phase 3 Talicia ® (omeprazole magnesium, amoxicillin and rifabutin)[1] and Movantik ® (naloxegol)[2] data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021 . The first Talicia analysis evaluated physician-directed therapy data, confirming... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish , RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO-Europe Digital Conference, taking place October 25-28, 2021 . The presentation will be available on-demand for 30 days on the Company's website from the start of the conference:... Read More

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 American Depositary Shares (ADSs) of RedHill between... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its U.S. approved medicine indicated for the treatment of H. pylori infection in adults . This patent reinforces the protection for Talicia... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia ® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective October 1, 2021 . Coverage for... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved... Read More

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 Aurobindo Pharma USA , Inc. resolving their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in hospitalized patients with severe COVID-19 pneumonia. Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor... Read More

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, a novel antiviral serine protease... Read More

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... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results of a new preclinical study demonstrating opaganib's (ABC294640) [1] efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model. Reports suggest that over 20% of hospitalized COVID-19 patients experience acute renal failure... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik ® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and... Read More

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 dosages... Read More

RedHill Biopharma to Present at H.C. Wainwright Annual Global Investment and Cantor Global Healthcare Conferences RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September: H.C. Wainwright 23 rd Annual Global Investment Conference (September 13-15, 2021) Presentation: Available from Monday,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September: H.C. Wainwright 23 rd Annual Global Investment Conference ( September 13-15, 2021 ) Presentation: Available from Monday, September 13, 2021 , 7:00 a.m. EDT Speaker: Guy Goldberg , Chief Business Officer Cantor Global Healthcare... Read More

RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the second quarter ended June 30, 2021 . Dror Ben-Asher , RedHill's Chief Executive Officer, said: "We have achieved important progress across the board this quarter. Opaganib is one of the leading drug candidates in the race to develop an effective... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing strong inhibition by opaganib (ABC294640)[1] of Delta variant replication while maintaining cell viability at relevant concentrations. Working with the University of Louisville Center for Predictive Medicine, opaganib was studied in a 3D tissue model... Read More

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... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued two new patents, one covering opaganib for treating Ebola virus disease, with patent protection until 2035, and the other covering RHB-104 for treating bacterial infections, with protection through 2029. "Opaganib's potent activity against... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its second quarter 2021 financial results and operational highlights on Thursday, August 26, 2021 . The Company will host a webcast on Thursday, August 26, 2021 , at 8:30 a.m. EDT , during which it will present key highlights. The webcast including slides will be broadcast live on the... Read More

RedHill Biopharma Announces Settlement of Movantik ® Patent Litigation with Apotex 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 Apotex, Inc. and Apotex Corp. ('Apotex')... Read More

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 Apotex, Inc. and Apotex Corp. ("Apotex") resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New... Read More

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,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that OptumRx, part of the UnitedHealth Group - a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, has added Talicia ® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Commercial Formulary as an unrestricted brand for H. pylori... Read More

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... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640) [1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line results are expected in the coming... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, has added Movantik ® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation (OIC), as a preferred brand with no restrictions to a... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing potent inhibition of COVID-19 variants of concern by opaganib (Yeliva ® , ABC294640) [1] . Opaganib, a leading novel investigational oral pill in development for the treatment of COVID-19, is a unique host-targeted, dual antiviral and... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation of the positive Phase 2 safety and efficacy data for oral opaganib (Yeliva®, ABC294640)[1] in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum (WMF) 2021 (poster #: 5574). Results and post hoc analyses of data from the 40-patient U.S. Phase 2 study were presented in a... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish , RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO Digital International Convention, taking place June 14-18, 2021 . The presentation will be available on the Company's website for 30 days from the start of the conference:... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has completed enrollment and randomized the last patient in the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia ( NCT04467840 ). A total of 475 patients were randomized, more than the planned 464. The primary endpoint of the... Read More

The Summer Solstice - Best Ideas from the Buy-Side will take place on June 1-4, 2021, where 35 SmallCap, MicroCap and NanoCap public companies will be presenting via virtual webcast to a global investor audience. The Summer Solstice - Best Ideas from the Buy Side: VIRTUAL begins on Tuesday, June 1, 2021, with company presentations beginning at 9am Eastern Time. Presentations will be webcast on Tuesday and Wednesday (June 1... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the first quarter ended March 31, 2021 . Dror Ben-Asher , RedHill's Chief Executive Officer, said: "The progress of our two novel, oral COVID-19 programs has put RedHill at the forefront of oral COVID-19 therapeutics development. Opaganib, one of the... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib [1] and RHB-107 (upamostat) [2] as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus. Both opaganib and RHB-107 are novel COVID-19 therapeutic candidates, in oral pill form, with... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at Digestive Disease Week (DDW) 2021 of two new analyses of Movantik ® Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC). Both analyses included pooled data from two large,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation (poster number: Fr244) at Digestive Disease Week 2021 of a new Travelers' Diarrhea (TD) severity classification tool providing clear separation of clinical severity categories and prognostic information for TD resolution, with potential utility in clinical practice. The new tool was... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2021 financial results and operational highlights on Thursday, May 27, 2021 . The Company will host a webcast on Thursday, May 27, 2021 , at 8:30 a.m. EDT , during which it will present key highlights for the first quarter of 2021. The webcast including slides will... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva ® , ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has acted on a request to provide opaganib [1] treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from COVID-19 pneumonia. Acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered... Read More

Financials: Full year 2020 net revenues of approximately $64 million , with gross profit of approximately $27.5 million Solid cash balance of approximately $100 million as of March 4, 2021 Planned commercial operational breakeven by the end of 2021 Commercial Highlights : Talicia: Consistent month-over-month prescription growth despite pandemic conditions, with 52% new prescription growth in Q4/2020 compared to Q3/2020... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its fourth quarter and full year 2020 financial results and operational highlights on Thursday, March 18, 2021 . The Company will host a conference call and webcast on Thursday, March 18, 2021 , at 8:30 a.m. EDT , during which it will present key highlights for the full year of 2020,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following upcoming virtual conferences in March: Sachs Spring Life Sciences Week ( March 8-11, 2021 ) 14 th Annual European Life Sciences CEO Forum Presentation: Available on-demand from March 8 Speaker: Guy Goldberg , Chief Business Officer 2 nd Annual European HealthTech CEO... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 4,375,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. H.C. Wainwright & Co. acted as the sole... Read More

ObvioHealth , a global virtual research organization or VRO, today announced the launch of a hybrid clinical trial for the treatment of COVID-19, using an innovative study design with digital data capture to remotely monitor patient vitals. This U.S. Phase 2/3 study will examine the safety and efficacy of RedHill Biopharma's... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 4,375,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and commissions. Each... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,250,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plans to expand the Company's global Phase 2/3 study of opaganib [1] in patients with severe COVID-19 to the U.S., following U.S. Food and Drug Administration (FDA) review of the data from the U.S. Phase 2 study of opaganib and receipt of its recommendations. Expansion of the global Phase 2/3 study... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced agreements with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to manufacture two key products; RedHill's largest selling product in the U.S., Movantik ® , and RHB-204, currently in a Phase 3 U.S. study as a stand-alone, first-line orally-administered treatment for pulmonary nontuberculous mycobacteria... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient was dosed in its U.S. Phase 2/3 study of orally-administered RHB-107 (upamostat) [1] , an investigational new drug for patients with symptomatic COVID-19 who do not require hospital care. Dror Ben-Asher , RedHill's CEO said : "RedHill is rapidly advancing two Phase 3-stage,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in February: SVB Leerink 10 th Annual Global Healthcare Conference ( Feb 22-26, 2021 ) Presentation and Q&A: Thursday, February 25 , 8:40 am ET Speaker: Dror Ben-Asher , Chief Executive Officer BIO CEO & Investor Digital Conference ( Feb 16-18,... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib [1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and... Read More

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva ® , ABC294640) [1] , to address prospective demand subsequent to potential global emergency use authorizations. "The growing concerns over viral mutations and the... Read More