RDHL
Redhill BiopharmaRDHL
RDHL
About: Redhill Biopharma Ltd is a specialty biopharmaceutical company focused on gastrointestinal diseases. The company is focused primarily on the advancement of its development pipeline of clinical-stage therapeutic candidates. The company also commercializes in the U.S. GI-related products, Talicia (omeprazole, amoxicillin, and rifabutin) and Aemcolo (rifamycin). The company's current pipeline consists of five therapeutic candidates, which are Opaganib, RHB-107, RHB-102, RHB-204, and RHB-104, most of which are in clinical development.
Employees: 53
0
Funds holding %
of 7,372 funds
–
Analysts bullish %
Fund manager confidence
Based on 2024 Q4 regulatory filings by fund managers ($100M+ AUM)
300% more repeat investments, than reductions
Existing positions increased: 4 | Existing positions reduced: 1
114% more capital invested
Capital invested by funds: $48.8K [Q3] → $104K (+$55.7K) [Q4]
50% more first-time investments, than exits
New positions opened: 3 | Existing positions closed: 2
10% more funds holding
Funds holding: 10 [Q3] → 11 (+1) [Q4]
0.03% less ownership
Funds ownership: 0.03% [Q3] → 0% (-0.03%) [Q4]
Research analyst outlook
We haven’t received any recent analyst ratings for RDHL.
Financial journalist opinion
Based on 3 articles about RDHL published over the past 30 days
Neutral
PRNewsWire
2 days ago
RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn's Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results
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-104 3 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 inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes -- Based on insights from RHB-104's statistically significant positive Phase 3 study results, the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability, safety and adherence, and along with the uniquely defined patient population (MAP-positive), allows for a study design with a small sample size and decisive endpoints, entailing lower study costs and expedited timeframe -- The role of MAP as a cause of CD, to be tested in this study, supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease, not the symptoms -- The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033, presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C.
Neutral
PRNewsWire
2 weeks ago
RedHill Presents Business Update at the Sachs' European Life Sciences CEO Forum
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 deal Initiation of the Bayer-funded Phase 2 clinical study of opaganib [2] in combination with Bayer's (ETR: BAYN) darolutamide in advanced prostate cancer Status of the U.S. government-supported pipeline programs and expected 2025 catalysts Significant commercial progress with Talicia®: Additional marketing authorization applications in new markets being evaluated Discussions ongoing focused on significant cost of goods (COGs) reduction Inclusion as first-line option for treatment of H. pylori infection in American College of Gastroenterology (ACG) Clinical Guideline Humana®'s Part D Plan coverage adds access for more than eight million additional Medicare lives, without prior therapeutic steps or authorization Surpassed 100,000 prescriptions milestone, maintaining position as the #1 brand prescribed by gastroenterologists Ground-breaking warranty program launched - minimal claimed refunds New data on more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine published in the Journal of Clinical Pharmacology supporting prior FDA sNDA approval for TID dosing Out-license, approval and launch in the United Arab Emirates RALEIGH, N.C.
Neutral
PRNewsWire
2 weeks ago
RedHill Licenses RHB-102 for Commercialization Worldwide Excluding North America to Hyloris for up to $60 Million in Potential Milestone Payments Plus Royalties
- 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.
Neutral
PRNewsWire
1 month ago
RedHill Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer
The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC) , testing the potentially enhancing effect of opaganib in patients with a poor prognosis The study is being financially supported by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor Lisa Horvath from Chris O'Brien Lifehouse and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) The study will utilize a companion lipid biomarker test (PCPro [1] ) to select mCRPC patients who have a poor prognosis due to standard of care treatment and who may benefit from an opaganib + darolutamide combination treatment approach . Primary endpoint will be improved 12-month radiographic progression-free survival (rPFS) Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths.
Neutral
PRNewsWire
1 month ago
RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published
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.
Neutral
PRNewsWire
3 months ago
Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development
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 Diseases (NIAID), which leads the RNCP, regarding plans for the next phase of development along the U.S. Food and Drug Administration's (FDA) Animal Rule pathway to approval TEL AVIV, Israel and RALEIGH, N.C. , Dec. 10, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.
Neutral
PRNewsWire
3 months ago
RedHill Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court
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.
Neutral
PRNewsWire
4 months ago
RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND
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 investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs).
Neutral
PRNewsWire
4 months ago
RedHill Announces Collaboration with a Leading U.S. Academic Medical Center to Develop Opaganib as a Countermeasure Against Phosgene Inhalation Injury
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.
Neutral
PRNewsWire
4 months ago
RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment
The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV) -- The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential approval as an MCM for EBOV -- Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase in survival in an in vivo EBOV model. The BARDA research and development contract provides initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and contain EBOV outbreaks -- This year marks the 10th anniversary of the West Africa Ebola epidemic in which 11,000 people died, and there is still an urgent need for effective and useable therapies, with EBOV proving fatal in around half of all cases according to the World Health Organization (WHO) 1 -- Opaganib, a novel potentially broad-acting drug, has shown mutation-resistant antiviral and anti-inflammatory activity, likely to directly impact vascular health - one of the main targets for EBOV dysfunction.
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