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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RedHill Biopharma Ltd.'s stock RDHL, +1.65% soared 10% premarket after the company said it has received a further $1.7 million in U.S. government funding for its partner, Apogee, to develop a treatment for gastrointestinal acute radiation syndrome.

RedHill Biopharma's stock soars 10% after company gets U.S. funding to develop treatment for radiation sickness

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 contract awarded to opaganib following its selection by the RNCP for ARS development This SBIR grant, and the earlier selection by the RNCP, follows FDA confirmation of Animal Rule regulatory pathway applicability for opaganib for ARS, utilizing pivotal animal model efficacy studies as the basis for FDA approval instead of human efficacy trials 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 in mass casualty radiological or nuclear incidents, if approved by the FDA Opaganib is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome (ARDS), oncology and additional indications TEL AVIV, Israel and RALEIGH, N.C. , July 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Announces Additional U.S. Government Funding for Opaganib Nuclear Countermeasure Development

SAN FRANCISCO--(BUSINESS WIRE)--Phil Inc., a patient access platform company that revolutionizes life science product commercialization, today announced an agreement with RedHill Biopharma (Nasdaq: RDHL) (‘RedHill') to make its medication Talicia® (omeprazole magnesium, amoxicillin, and rifabutin) available via the PhilRx Patient Access Platform. The PhilRx Patient Access Platform provides end-to-end visibility into the entire prescription life cycle, starting the moment the physician writes a.

Phil and RedHill Biopharma Partner to Increase Access to Talicia®

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 prioritized, including potential non-dilutive funding, following termination of RHB-204 Phase 3 study due to low accrual rate TEL AVIV, Israel and RALEIGH, N.C. , June 12, 2023 /PRNewswire/ --  RedHill Biopharma Ltd.

RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights

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 potential treatment for Acute Radiation Syndrome (ARS) and other indications, RHB-102 – with a potential UK marketing approval submission for oncology support , and additional clinical stage programs TEL AVIV, Israel and RALEIGH, NC , May 22, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the termination of RHB-204's[1] U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to a very low accrual rate, and the shifting of the Company's resources to advance once-daily, oral RHB-107's[2] late-stage development for outpatient treatment of COVID-19.

RedHill Provides R&D Update

TEL AVIV, Israel and RALEIGH, N.C. , May 15, 2023 /PRNewswire/ --  RedHill Biopharma Ltd.

RedHill Biopharma Receives NASDAQ Notification Regarding Minimum Market Value of Publicly Held Shares Deficiency

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 prescribed branded H.

RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week

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, N.C. , May 1, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill's RHB-102 (BEKINDA®) and Opaganib Granted New Patents in Oncology Setting

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 regulatory pathway, with Priority Review Voucher potential Positive UK MHRA scientific advisory meeting for RHB-102 (BEKINDA®) - UK Marketing Authorisation Application (MAA) for oncology support planned; Discussions with potential commercialization partners ongoing Talicia® delivers year-over-year prescription growth of 57% and first ever warranty program for a widespread community-treated condition 1  established Cash balance of $36.1 million as of December 31, 2022 2 ; Reduced operating loss of $9.9 million in Q4/22, compared to $20.7 million in Q4/21; Following the sale of Movantik in exchange for all debt, the consolidated commercial organization will be transitioning to growing Talicia® and Aemcolo® sales and addressing the impact of gross-to-net allowances on revenues JOHANNESBURG , April 28, 2023 /PRNewswire/ --  RedHill Biopharma Ltd.  (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its fourth quarter and full year 2022 financial results and operational highlights.

RedHill Biopharma Announces Q4/22 & Full-Year 2022 Results and Operational Highlights

TEL AVIV, Israel and RALEIGH, N.C. , April 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Closing of $6 Million Registered Direct Offering

TEL AVIV, Israel and RALEIGH, N.C. , March 30, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces $6 Million Registered Direct Offering

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, lowering the bar for patient access to an H. pylori therapy with a demonstrated more than 90% cure rate in the confirmed adherent population Talicia, the leading prescribed branded H.

RedHill Initiates First Community-Setting Warranty Program to Refund Talicia Non-Responders

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 an exemption from the registration requirements of the Securities Act of 1933, as amended.

RedHill Biopharma Announces Definitive Agreement for Up To $6 Million Private Placement with a Single Investor

RedHill's Opaganib Selected by the NIH Radiation and Nuclear Countermeasures Program 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 public health emergency.

RedHill Biopharma Ltd Announces RDHL Opaganib Selected by NIH RNCP For Development

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 public health emergency. As part of this collaboration with RedHill, studies will be undertaken to validate opaganib's efficacy in established pre-clinical animal models of ARS The Company expects research support provided by the RNCP collaboration to significantly accelerate and enhance the development program for opaganib, allowing access to key research models and resources Selection by the RNCP follows recent U.S Food and Drug Administration (FDA) guidance to RedHill about the applicability of the Animal Rule regulatory pathway for opaganib for ARS, utilizing pivotal animal model efficacy studies and human safety instead of human efficacy trials RedHill will work closely with the RNCP on development of opaganib as a potential radiation medical countermeasure.

RedHill's Opaganib Selected by the NIH Radiation and Nuclear Countermeasures Program

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 MHRA, RHB-102 could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of CINV/RINV TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / February 16, 2023 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda)[i] for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) in adults and children over the age of 12.

RedHill Biopharma Ltd Announces RedHill's RHB-102 Positive MHRA Meeting & MAA Plan

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 CINV/RINV TEL-AVIV, Israel and RALEIGH, N.C. , Feb. 16, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Announces Positive MHRA Meeting and Planned UK Marketing Authorisation Application of RHB-102 (BEKINDA®) for Oncology Support

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 central stockpiling by governments against mass casualty nuclear radiation incidents RedHill plans to work closely with the FDA on development of opaganib as a nuclear medical countermeasure and is set to continue to collaborate with a range of U.S. agencies and other governments on this and other indications Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher TEL AVIV, Israel and RALEIGH, N.C. , Feb. 15, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome

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 February 23, 2020 (as amended) in exchange for the transfer of its rights in Movantik® (naloxegol) to Movantik Acquisition Co., an affiliate of HealthCare Royalty ("HCR").

RedHill Biopharma and HealthCare Royalty Agree to Extinguish All RedHill's Debt Obligations in Exchange for Movantik®

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Redhill Biopharma (NASDAQ: RDHL ) stock is rocketing higher on Friday after getting positive patent news from the U.S. Patent and Trademark Office (USPTO). The USPTO issued a Notice of Allowance that grants the company a patent for RHB-204's treatment methods.

Why Is Redhill Biopharma (RDHL) Stock Up 32% Today?

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 years market exclusivity in the U.S. and 10 years exclusivity in the EU The Company is advancing discussions with several prospective partners for RHB-204 across multiple territories TEL AVIV, Israel and RALEIGH, N.C. , Jan. 26, 2023 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Receives USPTO Notice of Allowance for a Patent Covering Phase 3-stage RHB-204 for the Treatment of NTM Disease

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 hospitalization due to COVID-19 RHB-107, a novel, broad-acting, host-directed, once-daily oral antiviral, is expected to act independently of viral spike protein mutations including Omicron BA.5 sub-variant [1] Inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients pending.

RedHill Announces Publication of Positive Phase 2 Study Results with Once-Daily Oral RHB-107 in Non-Hospitalized COVID-19

NEW YORK, NY / ACCESSWIRE / December 7, 2022 / Aegis Capital Corp. acted as Sole Bookrunner on an $8 Million Underwritten Public Offering for RedHill Biopharma Ltd. (NASDAQ:RDHL).

Aegis Capital Corp. Acted as Sole Bookrunner on an $8 Million Underwritten Public Offering for RedHill Biopharma Ltd. (NASDAQ:RDHL)

TEL AVIV, Israel and RALEIGH, N.C. , Dec. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

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