Key Highlights and Upcoming Milestones: NDA submitted to the FDA for Talicia ® for H. pylori infection, with potential U.S. commercial launch in Q4/2019, assuming FDA approval FDA meeting planned for H2/2019 to discuss design of confirmatory Phase 3 study and path to potential approval for RHB-104 ...
The NDA follows a recent positive pre-NDA meeting with the FDA The NDA for Talicia ® is eligible for six-month priority review Talicia ® is eligible for a total of eight years of U.S. market exclusivity, in addition to patent protection until at least 2034 RedHill continues to strengthen its ...
TEL-AVIV, Israel and RALEIGH, N.C. , April 30, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. ( Nasdaq : RDHL) ( Tel-Aviv Stock Exchange : RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced that it will report ...
TEL-AVIV, Israel and RALEIGH, N.C. , April 04, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ( Tel-Aviv Stock Exchange : RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced that the Company will ...
TEL-AVIV, Israel and RALEIGH, N.C. , March 18, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ( Tel-Aviv Stock Exchange : RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, today announced that Mr. ...
TEL-AVIV, Israel and RALEIGH, N.C. , March 11, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ( Tel-Aviv Stock Exchange : RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, today announced that Mr. ...
The European and Japanese patent applications have been accepted and, once granted, are expected to be valid until 2034 U.S. NDA for Talicia ® on track for potential submission in H1/2019 and U.S. commercial launch in Q4/2019 Talicia ® was granted QIDP designation, including eligibility for ...
TEL-AVIV, Israel and RALEIGH, N.C. , Feb. 21, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ( Tel-Aviv Stock Exchange : RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced ...
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