RedHill Biopharma

RedHill Biopharma Ltd. develops medicines for gastrointestinal and infectious diseases. It operates through Commercial Operations, and the Research and Development segments. The Commercial Operations segment covers all areas relating to the commercial sales and is being performed by the subsidiary in the U.S. The Research and Development segment includes the study and licensing of therapeutic candidates. Its products include Talicia, Movantik, and Aemcolo. The company was founded by Dror Ben-Asher and Ori Shilo on August 3, 2009 and is headquartered in Tel Aviv, Israel.

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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 505(b)(2) Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H.

RedHill Announces New USPTO Patent Covering Talicia® Through 2034

Gilead Sciences

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 investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure Selection for the therapeutic testing/screening program, following opaganib's previous acceptance into the Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS), provides the potential to see broad activity across both radiation and Sulfur Mustard injuries Opaganib has five-year shelf-life and is easy to administer and distribute for use against potential chemical weapon attack, if approved by the U.S. Food and Drug Administration (FDA) Opaganib is being developed for multiple additional indications, including COVID-19, acute respiratory distress syndrome (ARDS) and oncology TEL AVIV, Israel and RALEIGH, N.C. , March 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs

Amgen

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 molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use as radioprotection therapy in mass casualty radiological or nuclear incidents, if approved by the FDA Opaganib is being tested as a potential treatment for Acute Radiation Syndrome (ARS) following selection by the U.S government National Institutes of Health's (NIH) Radiation and Nuclear Countermeasures Program (RNCP) for its radiation medical countermeasures Product Development Program  Opaganib is being developed for multiple additional indications, including COVID-19, acute respiratory distress syndrome (ARDS), filoviruses (including Ebola) and oncology TEL AVIV, Israel and RALEIGH, N.C. , Feb. 20, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill's Opaganib Protects Against Radiation-Induced Lung Inflammation and Fibrosis - New Publication

TEL AVIV, Israel and RALEIGH, N.C., Jan. 26, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Closing of $8 Million Registered Direct Offering

TEL AVIV, Israel and RALEIGH, N.C. , Jan. 25, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces $8 Million Registered Direct Offering

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 Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, additional to the three years' exclusivity granted for the approval of Talicia under section 505(b)(2) Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists [4] for eradication of H.

RedHill Announces New USPTO Patent Grant for Talicia® for H. pylori Treatment Through 2042

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RedHill Biopharma Ltd. American depositary receipts RDHL, +8.20% climbed 10% premarket on Wednesday after the company said two of its experimental drugs, when individually combined with remdesivir, showed promise in combating the Ebola virus.

RedHill Biopharma shares jump as Ebola treatment shows promise

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 activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having recently delivered a statistically significant increase in survival time in a separate U.S. Army-funded in vivo Ebola virus study . RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment TEL-AVIV, Israel and RALEIGH, N.C.

RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

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 300-patient Phase 2 RHB-107 arm has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024 RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study [2] If approved, RHB-107, a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations [3] , would target the multi-billion-dollar early COVID-19 treatment market RALEIGH, N.C.

RedHill Announces New, Non-Dilutive External Funding of Entire RHB-107 COVID-19 300-Patient Phase 2 Study

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Redhill Biopharma (NASDAQ: RDHL ) stock is sliding lower on Thursday but only after the company's shares come off of a recent rally. Shares of RDHL stock saw major gains earlier in the week.

Why Is Redhill Biopharma (RDHL) Stock Down 27% Today?

RedHill Biopharma Ltd (NASDAQ: RDHL) just received an exclusive licence for the commercialisation of Talicia. The drug is used to treat Helicobacter Pylori infections, commonly known as H- Pylori.

RedHill Biopharma (RDHL) gained 216% after FDA approvals: Buy Now!

Amid a slow start to the new week, specialty drug developer RedHill Biopharma (NASDAQ: RDHL ) dramatically enlivened the mood, skyrocketing over 180% during the early afternoon session. Catapulting sentiment was regulatory approval for Talicia, a therapeutic designed to target helicobacter pylori (H.

5 Investors Betting Big on RedHill Biopharma (RDHL) Stock

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 leading branded first-line therapy prescribed by U.S. gastroenterologists 1  for eradication of H.

RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia® with IP Protection Running to 2034

TEL AVIV, Israel & RALEIGH, N.C. , Nov. 14, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces the Transfer of its Listing to The Nasdaq Capital Market

- 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 late-stage clinical studies of patients hospitalized with moderate to severe COVID-19; opaganib was also selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development TEL AVIV, Israel and RALEIGH, NC , Oct. 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that novel, twice daily, oral opaganib[1], delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.

RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study

TEL AVIV, Israel & RALEIGH, N.C. , Sept. 22, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

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.

RedHill Announces FDA sNDA Approval for Talicia®

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 until March 2035 TEL-AVIV, Israel and RALEIGH, N.C. , Sept. 5, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Announces New USPTO Notice of Patent Allowance for Opaganib and EU Patent Grant for RHB-102 (BEKINDA®)

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 Health's Radiation and Nuclear Countermeasures Program (RNCP) product development contract for gastrointestinal acute radiation syndrome (GI-ARS) Following the divestiture of Movantik and the ongoing commercial and financial streamlining, the Company is debt-free, with a significantly reduced cost-base  H1/23 Talicia net revenues of $5.1 million; Cash balance of $16.3 million as of June 30, 2023 [1] TEL AVIV, Israel and RALEIGH, N.C. , Aug. 17, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights

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. gastroenterologists [1] for eradication of H.

RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S.

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 clearance to start (expected Q3/23) and is estimated to be completed by end of 2024  If approved, RHB-107, a novel, oral, once-daily, broad-acting, host-directed antiviral is expected to act independently of viral spike protein mutations 1 , would potentially target a multi-billion-dollar early COVID-19 treatment market  RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study 2    TEL AVIV, Israel and RALEIGH, NC , July 31, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RHB-107 (upamostat)3 has been accepted for inclusion in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. Government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa.

RedHill's RHB-107 Included in U.S. Government-Supported COVID-19 Platform Trial and Cleared for Initiation by FDA

TEL AVIV, ISRAEL, and RALEIGH, N.C. , July 25, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Closing of $3.8 Million Registered Direct Offering and Warrant Exercise

TEL AVIV, ISRAEL & RALEIGH, N.C. , July 21, 2023 /PRNewswire/ --  RedHill Biopharma Ltd.

RedHill Biopharma Announces Registered Direct Offering and Warrant Exercise for $3.8 Million Gross Proceeds

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