RedHill Biopharma

448 articles with RedHill Biopharma

• RedHill Biopharma Announces Plan to Implement ADS Ratio Change

  3/16/2023

  RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that it plans to implement a ratio change of the Company's American Depositary Shares to its non-traded ordinary shares from the current ratio of one ADS representing ten ordinary shares to a new ratio of one ADS representing four hundred ordinary shares.

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

  3/9/2023

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

  2/28/2023

  RedHill Biopharma Ltd. announced that the Radiation and Nuclear Countermeasures Program, of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has selected opaganib1 for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome.

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

  2/28/2023

  RedHill Biopharma Ltd. has selected opaganib[1] for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS).

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

  2/16/2023

  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.

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

  2/16/2023

  RedHill Biopharma Ltd. 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.

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

  2/15/2023

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the positive outcome of a scheduled Type B meeting with the U.S. Food and Drug Administration (FDA) for the development of opaganib for Acute Radiation Syndrome (ARS) in which the FDA provided guidance on opaganib's developmental pathway to potential approval under the Animal Rule.

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

  2/6/2023

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

  1/26/2023

  RedHill Biopharma Ltd. today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the granting of a patent covering RHB-204's1 oral fixed-dose combination.

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

  1/3/2023

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat)[2] in non-hospitalized symptomatic COVID-19 patients.

• RedHill Biopharma Closes $8.0 Million Underwritten Public Offering

  12/6/2022

  RedHill Biopharma Ltd., a specialty biopharmaceutical company, 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.

• RedHill's Aemcolo® Granted FDA QIDP 5-Year Exclusivity Extension

  12/5/2022

  RedHill Biopharma Ltd. today announced that the U.S. Food and Drug Administration's (FDA) Exclusivity Board has granted Aemcolo®2 five years' exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years' data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers' diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.

• RedHill Biopharma Prices $8.0 Million Underwritten Public Offering

  12/2/2022

  RedHill Biopharma Ltd. today announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $8.0 million.

• RedHill Biopharma Announces Proposed Public Offering - December 01, 2022

  12/1/2022

  RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that it intends to offer and sell, subject to market and other conditions American Depositary Shares and warrants to purchase ADSs in an underwritten public offering.

• RedHill Biopharma Announces Q3/22 Results and Operational Highlights

  11/29/2022

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its third quarter 2022 financial results and operational highlights.

• RedHill Biopharma Announces Positive New Data with Opaganib for Nuclear Radiation Injury

  11/17/2022

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive in vivo results from a new pre-clinical study evaluating the effects of opaganib[1] on radiation-induced hematologic and renal toxicity, undertaken by RedHill and its partner Apogee Biotechnology Corporation ("Apogee").

• RedHill Biopharma Reaches Agreement in Principle with HCR to Extinguish All Debt Obligations in Exchange for Movantik®

  11/14/2022

  RedHill Biopharma Ltd. announced that it has reached a non-binding agreement in principle with HCR Collateral Management, LLC with respect to the terms of a transfer of RedHill's rights in Movantik® to HCR in exchange for the extinguishment of all RedHill's obligations under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HCR dated as of February 23, 2020.

• RedHill Accelerates Opaganib's Nuclear Radiation Protection Program - Positive Data Published

  11/14/2022

  RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced acceleration of opaganib's development program for protection against radiation injury and cancer radiotherapy.

• RedHill Biopharma Provides H1/22 Highlights and Q3/22 Estimates

  11/7/2022

  RedHill Biopharma Ltd., a specialty biopharmaceutical company, reported its second quarter 2022 financial results and operational highlights, restatement of first quarter 2022 financial results and the provision of third quarter 2022 estimates.

• RedHill Presents New Talicia® Data Analyses at Obesity Week 2022

  11/4/2022

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new Talicia® data analyses for the treatment of H. pylori, at the Obesity Week Annual Meeting, November 1-4, 2022.