RedHill Biopharma Ltd., a specialty biopharmaceutical company, primarily focused on gastrointestinal and infectious diseases. The company promotes gastrointestinal drugs, including Movantik for opioid-induced constipation in adults with chronic non-cancer pain; Talicia for the treatment of Helicobacter pylori infection in adults; and Aemcolo for the treatment of travelers' diarrhea in adults. Its clinical late-stage investigational development programs include RHB-204, which is in Phase 3 study for pulmonary nontuberculous mycobacteria infections; opaganib (Yeliva), an SK2 selective inhibitor, which has completed Phase 2 study to treat patients with SARS-CoV-2 severe COVID-19 pneumonia, in Phase 1/2a study to treat advanced unresectable cholangiocarcinoma, and in investigator-sponsored Phase 2 study to treat prostate cancer; RHB-104, which is in Phase 3 studies for Crohn's disease; RHB-102 (Bekinda) that is in Phase 3 studies for acute gastroenteritis and gastritis, and has completed Phase 2 studies for irritable bowel syndrome with diarrhea; RHB-107, which is in Phase 2/3 study to treat outpatients infected with COVID-19 disease, and Phase 2a study to treat advanced unresectable cholangiocarcinoma, as well as has completed Phase 2 study to treat gastrointestinal and other solid tumors; and RHB-106, an encapsulated formulation for bowel preparation, which has completed Phase 2a study. The company was incorporated in 2009 and is headquartered in Tel Aviv, Israel.
IPO Year:
Exchange: NASDAQ
Website: redhillbio.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 9/15/2021 | $23.00 → $21.00 | Buy | HC Wainwright & Co. |
| 8/31/2021 | $22.00 | Overweight | Cantor Fitzgerald |
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RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics Talicia is also approved and launched in the UAE4 and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes H. pylori infection is a billion-dollar market opportunity affecting approximate
The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 -- Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative of RHB-1043 which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy. The i
Guy Goldberg, RedHill's Chief Business Officer, presents today a business update at the European Life Sciences CEO Forum The update covers: The recent out-licensing of RHB-102[1] to Hyloris (Euronext Brussels: HYL) in a potential $60 million plus royalties dealInitiation of the Bayer-funded Phase 2 clinical study of opaganib[2] in combination with Bayer's (ETR: BAYN) darolutamide in advanced prostate cancerStatus of the U.S. government-supported pipeline programs and expected 2025 catalystsSignificant commercial progress with Talicia®:Additional marketing authorization applications in new markets being evaluatedDiscussions ongoing focused on significant cost of goods (COGs) reductionInclusio
- Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda®) across all indications and territories outside the United States, Canada and Mexico - Recent positive UK MHRA advice provided a clear pathway for a UK Marketing Authorization Application (MAA). If approved, RHB-102 could be the first oral 24-hour extended-release ondansetron for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV) - RedHill intends to continue development of RHB-102 for FDA approval in the U.S., if granted. Hyloris will
Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists Additionally, new data describing the foundations for Talicia's recent FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, has been publi
Heightened geopolitical tensions and Homeland Security concerns call for the development of potential therapies that can be quickly and easily mobilized in the event of a mass casualty nuclear or radiological incident There are currently no known approved therapies for gastrointestinal acute radiation syndrome (GI-ARS) Positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirm opaganib's protective activity Discussions now ongoing with the National Institutes of Health's (NIH) National Institute of Allergy and Infectious
RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the agreements TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been awarded approximately $8 million (consisting of $6.5 million plus interest amounting to approximately $1.5 million), plus costs in a summary ju
- Dr. Almenoff brings more than 25 years of drug development and leadership experience to the Actinium Board of Directors - Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE:ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to nu
RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" -- Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA -- The JPEO-CBRND manages U.S. government inv
The collaboration outlines plans for multiple in vivo studies, designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury. The collaboration aims to determine whether opaganib can advance into further definitive U.S. government-sponsored development under the FDA's Animal Rule pathway to approval Used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides. The U.S. Environmental Protection Agency (EPA) identified 123 sites in the United States that could potentially expose millions of people to phosgene due to plant malfunction or biote
- Dr. Almenoff brings more than 25 years of drug development and leadership experience to the Actinium Board of Directors - Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE:ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to nu
HC Wainwright & Co. reiterated coverage of Redhill Biopharma with a rating of Buy and set a new price target of $21.00 from $23.00 previously
Cantor Fitzgerald initiated coverage of Redhill Biopharma with a rating of Overweight and set a new price target of $22.00
WBB Securities downgraded Redhill Biopharma from Strong Buy to Buy and set a new price target of $16.00 from $17.00 previously
HC Wainwright & Co. initiated coverage of Redhill Biopharma with a rating of Buy and set a new price target of $23.00
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Targeting positive cash from operations to start during H2/22[1] Focus on earlier achievement of operational profitability thanks to a recently implemented comprehensive cost reduction plan, with expected operational cost savings of approximately $50 million over the next 18 months Continuous implementation of disciplined cost controls reduced Q1/22 cash used in operating activities by more than 70% to approximately $4 million, compared to approximately $15 million in Q4/21 Net revenues of $18.2 million in Q1/22; Cash balance[2] of $45 million as of March 31, 2022 Talicia® TRx up 12.8% over Q4/21 and Movantik® continues strong Q4/21 prescription performance Amendment improves key covenants i
TEL AVIV, Israel and RALEIGH, N.C., June 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2022 financial results and operational highlights on Thursday, June 23, 2022. The Company will host a conference call and webcast on Thursday, June 23, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2022. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/ev
TEL AVIV, Israel and RALEIGH, N.C., March 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its operational highlights and financial results for the fourth quarter and full year ended December 31, 2021. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "In 2021, RedHill's team delivered record revenues against a pandemic backdrop, overall contribution of commercial operations to the company was positive for the first time in Q4/21 and positive late-stage clinical data for two novel oral COVID-19 drugs. A very strong fourth quarter for both Talicia® and Movantik®, coupled with disciplined c
TEL AVIV, Israel and RALEIGH, NC, March 10, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its fourth quarter and full year 2021 financial results and operational highlights on Thursday, March 17, 2022. The Company will host a conference call and webcast on Thursday, March 17, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the fourth quarter and full year of 2021. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days. To participate in the confer
TEL AVIV, Israel and RALEIGH, N.C., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021. The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days. To participate in the conference call, please dial one of the following num
62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)Th
TEL AVIV, Israel and RALEIGH, N.C., Oct. 4, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants. These important new
Achieved record quarterly revenues of $21.5 million for Q2/2021, 4.5% increase from Q1/2021 despite challenging market conditions; Cash balance[1] of approximately $71.5 million as ofJune 30, 2021Record Talicia® quarterly prescription volume up more than 10%; Movantik® quarterly new prescriptions up 5.6%; Talicia and Movantik coverage expanded to 8 and 9 out of 10 commercially insured Americans, respectivelyOpaganib in final stages of selection by Quantum Leap Healthcare Collaborative and BARDA for inclusion in the I-SPY COVID-19 platform trial with funding provided by BARDANew preclinical data supports opaganib's potent inhibition of Delta COVID-19 variantTop-line results from global Phase
TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the second quarter ended June 30, 2021. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have achieved important progress across the board this quarter. Opaganib is one of the leading drug candidates in the race to develop an effective COVID-19 therapeutic pill. New data further supports opaganib's potent inhibition of SARS-CoV-2 variants of concern, including the rapidly spreading Delta variant. The upcoming Phase 2/3 top-line data could tell
TEL AVIV, Israel and RALEIGH, NC, Aug. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its second quarter 2021 financial results and operational highlights on Thursday, August 26, 2021. The Company will host a webcast on Thursday, August 26, 2021, at 8:30 a.m. EDT, during which it will present key highlights. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days. To participate in the conference call, please dial one of the following numbers 15 minutes prior to the star