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: 35
0
Funds holding %
of 7,407 funds
–
Analysts bullish %
Fund manager confidence
Based on 2024 Q4 regulatory disclosures 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
1 day ago
RedHill Biopharma Receives Nasdaq Notification Regarding Minimum Stockholders' Equity Deficiency
The Notification Letter has no immediate effect on the Company's listing on the Nasdaq Capital Market at this time, nor are the Company's business operations affected by receipt of the Notification Letter TEL AVIV, Israel and RALEIGH, N.C. , April 17, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.
Neutral
PRNewsWire
3 days ago
RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption
GLP-1 comparable efficacy: Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models -- Novel mechanism of action, formulation and administration: Opaganib is a differentiated oral, non-peptide therapeutic that targets sphingosine kinase-2 (SPHK2), potentially avoiding common Glucagon-like peptide-1 (GLP-1) inhibitor side effects and administration burdens -- Market disruptor potential: The rapidly growing global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 [1] – largely driven by GLP-1 inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity®, Zepbound® and Mounjaro® -- Potential high value and de-risked development pathway: Existing human safety and tolerability data from over 470 subjects, from several clinical programs, may help expedite the FDA pathway to approval; new obesity and diabetes indications add strategic expansion and value to existing development programs in oncology, inflammatory and viral indications TEL AVIV, Israel and RALEIGH, N.C. , April 16, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.
Neutral
PRNewsWire
1 week ago
RedHill Biopharma Announces Full-Year 2024 Financial Results and Operational Highlights
Revenue-generating with an exciting, diversified, largely externally funded, advanced development pipeline and multiple upcoming catalysts. Recent highlights: Global licensing deal (excluding North America) with Hyloris Pharmaceuticals with RHB-102 for up to $60 million in potential milestone payments Approximately $8 million plus legal costs NY Supreme Court summary judgment win against Kukbo Bayer-supported Phase 2 combination study of opaganib and Bayer's darolutamide in prostate cancer initiated Talicia ® advancement and geographic expansion: Planned UK MAA with potential for approval in 2025 Commercially launched in the United Arab Emirates (UAE) Formulary wins securing 25 million covered lives First-line therapy listing in the recently updated ACG Guideline Advancing next-generation development, RHB-204, into the first ever Phase 2 clinical study in Crohn's Disease (CD) patients who are all MAP-positive, supported by RHB-104's positive Phase 3 data showing a statistically significant 64% improvement in efficacy; FDA path to approval guidance expected in coming weeks Positive results from new U.S. Government funded program for gastrointestinal Acute Radiation Syndrome (GI-ARS) further confirm opaganib's nuclear radiation protective activity.
Neutral
PRNewsWire
1 month ago
RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation
RedHill plans to submit UK MAA 1 for Talicia for H. pylori infection, using MHRA's 2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG 3 Clinical Guideline as a first-line option, Talicia is the leading branded H.
Neutral
PRNewsWire
1 month 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
1 month 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
1 month 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
2 months 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
2 months 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
4 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.
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