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.

Earnings data Q4 2019

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Analysis of treatment outcomes in five severe COVID-19 patients showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a matched case-control group from the same hospital  --  All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation whereas 33% of the matched case-control group required mechanical ventilation  --  Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group  --  Phase 2/3 Clinical Trial Applications submitted for a multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib in 270 patients with severe COVID-19 to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries  --  A randomized, double-blind, placebo-controlled study with opaganib in up to 40 patients with  severe COVID-19 initiated at leading medical centers across the U.S.

Publication of Data from Severe COVID-19 Patients Shows Substantial Benefit to Patients Treated with RedHill’s Opaganib Compared to Matched Case-Control Group

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study with opaganib in 270 severe COVID-19 patients is planned to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries

RedHill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK 

TEL-AVIV, Israel and RALEIGH, N.C., June  18, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Guy Goldberg, RedHill's Chief Business Officer, will present a corporate overview at the Virtual Life Sciences Investor Forum on Thursday, June 25, 2020, at 10 a.m. EDT.

RedHill Biopharma to Present at Virtual Life Sciences Investor Forum on June 25

RedHill (RDHL) submits a Clinical Trial Application in Russia for a phase II/III study on opaganib to treat patients detected with severe COVID-19 infection and pneumonia. Stock up.

RedHill Files CTA for Coronavirus Study on Opaganib in Russia

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study of opaganib for severe COVID-19 patients is planned to be conducted in Russia and additional European and other countries

RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

TEL-AVIV, Israel and RALEIGH, N.C., June  08, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Mr. Gilead Raday, RedHill’s Chief Operating Officer, will present the Company’s development program with opaganib (Yeliva®, ABC294640)1 for COVID-19, as well as the Phase 3 development program with RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections, at the MedInvest Virtual Infectious Diseases and Immunology Conference on Monday, June 15, 2020, at 12:40 p.m. EDT.

RedHill Biopharma to Provide Update on its COVID-19 and other Development Programs at MedInvest Virtual Infectious Diseases and Immunology Conference

Redhill Biopharma Ltd (RDHL) CEO Dror Ben-Asher on Q1 2020 Results - Earnings Call Transcript

Shares of Redhill Biopharma (NASDAQ:RDHL) rose 4.6% in pre-market trading after the company reported Q1 results.

Recap: Redhill Biopharma Q1 Earnings

Completed acquisition of Movantik® from AstraZeneca on April 1, 2020, and initiated U.S. promotion with net revenues of $7.3 million in April  --  Launched commercial sales of Talicia ®  in the U.S. in March 2020; Talicia  ®   added to Express Scripts and Prime Therapeutics formularies as an unrestricted, preferred brand for H. pylori  --  Net revenues of approximately $8.4 million in the first four months of 2020 ,  excluding Talicia® sales into the channel, an increase of 264% from the comparable period of 2019  --  Cash position of $115.1 million at the end of first quarter, and approximately $62.5 million immediately following Movantik  ®   acquisition; Net cash used in operating activities of $10.6 million in the first quarter  --  Pursuing two shots on goal strategy for COVID-19 with RedHill’s clinical-stage novel molecules opaganib (Yeliva ® ) and RHB-107; Initiation of U.S. Phase 2a study with opaganib ongoing  --  Initiation of Phase 3 clinical study in Nontuberculous Mycobacteria (NTM) planned for the third quarter of 2020  --  Management to host conference call today, at 8:30 a.m. EST

RedHill Biopharma Provides Q1/2020 Financial Results and Recent Highlights Including Initial Movantik® Revenues

Is  (RDHL) Outperforming Other Medical Stocks This Year?

Is Redhill Biopharma (RDHL) Stock Outpacing Its Medical Peers This Year?

RedHill's Covid-19 Program On Track, And Other News: The Good, Bad And Ugly Of Biopharma

Redhill Biopharma (NASDAQ: RDHL) shares are trading higher on Friday, after the company received FDA approval for its coronavirus clinical study with Opaganib in the U.S.

Why Redhill Biopharma's Stock Is Trading Higher Today

The randomized, double-blind, placebo-controlled study aims to enroll up to 40 patients with moderate-to-severe COVID-19 pneumonia in the U.S. --  All six analyzed moderate-to-severe COVID-19 patients treated with opaganib under compassionate use in Israel were weaned from oxygen and discharged from the hospital   --  Opaganib’s unique mechanism of action has both anti-inflammatory and anti-viral activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations    --  Continued progress towards compassionate use and clinical programs in additional countries  

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

Talicia® is approved by the U.S. FDA and promoted by RedHill’s U.S. sales force--  Abstract discussing Talicia pharmacokinetics and exposure-response presented as ePoster at Digestive Disease Week® (DDW) 2020

RedHill Biopharma Announces Publication of Talicia® Pivotal Phase 3 Study Results in Annals of Internal Medicine

REDHILL BIOPHAR/S ADR (NASDAQ: RDHL), known primarily as a biopharmaceutical company focused on gastrointestinal diseases, is joining the race to develop coronavirus treatments with two pipeline drugs it believes can help treat the disease that's triggered a pandemic.

RedHill's CEO On Biopharma's 'Two Shots On Goal' For Coronavirus Drug

Is Redhill Biopharma (RDHL) Outperforming Other Medical Stocks This Year?

Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies

RedHill Biopharma Strengthens Coverage for Talicia® with Preferred Brand Position on Prime Therapeutics NetResults™ National Formulary

The company's opaganib shows promise in the fight against the SARS-CoV-2 coronavirus following the completion of a compassionate-use program.

Why RedHill Biopharma Is Trouncing the Market Today

RedHill (RDHL) inks a deal with NIAID for non-clinical testing of its investigational candidate RHB-107 to evaluate its activity against COVID-19. Stock up.

RedHill's Oncology Candidate to be Tested for Coronavirus

RedHill is pursuing both RHB-107 and opaganib as potential treatments for COVID-19 RedHill is pursuing both RHB-107 and opaganib as potential treatments for COVID-19

RedHill Biopharma Announces Agreement with NIAID to Evaluate RHB-107 Against COVID-19

Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.  --  Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations    --  RedHill preparing for potential ramp-up of manufacturing of opaganib

IND for COVID-19 with Opaganib Submitted to the FDA by RedHill Biopharma

All five patients have shown an improved CRP, with four of the five patients also demonstrating measurable clinical improvement, including required supplemental oxygenation and higher lymphocyte counts  --  Opaganib was administered to all five patients in addition to standard-of-care, including hydroxychloroquine background therapy, and was well tolerated  --  Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations  --  Compassionate use plan in Italy to be converted to a clinical study, in line with the global shift to generate more robust data in a controlled setting for regulatory purposes

Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma

RedHill (RDHL) saw a big move last session, as its shares jumped more than 9% on the day, amid huge volumes.

RedHill (RDHL) Soars: Stock Adds 9.2% in Session

Objective improvement in first two patients treated with opaganib in Israel who have demonstrated measurable clinical improvement within days of treatment initiation, including decreased supplemental oxygen requirements, decreased C-reactive protein (CRP) levels and increased lymphocyte levels  --  One patient was treated in the ICU, was considered for intubation, and was released within days of treatment-initiation  --  Opaganib was administered in addition to standard-of-care, including hydroxychloroquine background therapy, and was well tolerated   --  Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations    --  Compassionate use program approved in Italy with 160 patients planned to be treated; Discussions ongoing in the U.S. and other countries to increase the accessibility of opaganib under similar programs, as well as potential emergency clinical development programs

News for RedHill Biopharma Stock (RDHL)