RedHill Biopharma Announces Positive Results for Opaganib Combined with Venetoclax in CLL
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
0mins
Should l Buy RDHL?
RedHill Biopharma announced positive in vivo results, indicating that opaganib combined with venetoclax reduces Chronic Lymphocytic Leukemia, CLL, cells by half compared to controls, and further demonstrates opaganib's potential as an add-on therapy to venetoclax in venetoclax-resistant CLL. Key highlights: Studies show that sphingosine kinase 2 is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previously resistant CLL cells; New in vivo study shows adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduces CLL cell counts by 50% compared to controls and lowered CD3+, CD4+ and CD8+ T cell counts compared to controls with lowered PD1 expression; Data shows opaganib's venetoclax combination potential in CLL; builds on multiple preclinical studies demonstrating opaganib's therapeutic add-on potential in oncology; further clinical evaluation ongoing in a Phase 2 study of opaganib + darolutamide in advanced prostate cancer; Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place
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Analyst Views on RDHL
About RDHL
RedHill Biopharma Ltd is an Israel-based specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs such as, Talicia for the treatment of Helicobacter pylori (H. pylori) infection, and Aemcolo, for the treatment of travelers’ diarrhea. RedHill’s clinical late-stage development programs include: :info: RHB-204, for pulmonary nontuberculous mycobacteria (NTM) disease; opaganib (ABC294640), host-directed, SPHK2 inhibitor targeting multiple indications, RHB-107 (upamostat), an oral, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; RHB-104 for Crohn's disease; and RHB-102 for chemotherapy and radiotherapy induced nausea and vomiting.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Stock Volatility: RedHill Biopharma's stock fell 4.29% to $1.34 on Tuesday after a 36% rally on Monday, indicating potential profit-taking that may affect investor confidence in the short term.
- Development Progress: The company announced advancements for RHB-102 (Bekinda) in multiple gastrointestinal indications, utilizing the FDA's accelerated 505(b)(2) pathway, which aims to address GI side effects associated with GLP-1/GIP receptor agonist therapies, presenting significant market potential.
- Clinical Data Support: Clinical data for RHB-102 comes from the U.S. Phase 3 GUARD gastroenteritis study and the positive Phase 2 IBS-D study, both meeting their primary endpoints, which are expected to provide strong support for FDA approval and potentially reshape the GLP-1 market landscape.
- Market Impact: With up to 50% of patients discontinuing GLP-1 receptor agonists within three months due to side effects, successful development of RedHill's therapy could mitigate the projected $35 billion reduction in GLP-1 market valuations by 2030.
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- Clinical Data Support: RHB-102 has shown positive results in U.S. Phase 3 and Phase 2 clinical trials for acute gastroenteritis and IBS-D, respectively, both meeting their primary endpoints, providing robust clinical data to support FDA approval.
- Intellectual Property Expansion: RedHill has also expanded the intellectual property coverage for RHB-102, ensuring its competitive edge across multiple indications, including GLP-1-associated side effects, further solidifying its position in the biopharmaceutical sector.
See More
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- Significant Efficacy: RedHill Biopharma's study indicates that the combination of opaganib and venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cell counts by 50%, providing new hope for treating venetoclax-resistant CLL patients.
- Mechanism Exploration: Research shows that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cells, and inhibiting SPHK2 may reduce T-cell-induced resistance, offering critical insights for personalized treatment strategies.
- Clinical Prospects: Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials, and is currently undergoing preliminary clinical trials in combination with darolutamide, further validating its potential across various cancers.
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See More
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- Efficacy Breakthrough: RedHill Biopharma's study reveals that combining Opaganib with Venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cell counts by 50%, providing new treatment hope for patients resistant to Venetoclax.
- Mechanism Exploration: Research indicates that SPHK2 is overexpressed in venetoclax-resistant cancer cells, and inhibiting SPHK2 may not only reduce T-cell-induced resistance but also resensitize previously resistant cells, thereby improving treatment outcomes for patients.
- Clinical Prospects: Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials, and is currently undergoing preliminary clinical trials in combination with Darolutamide, further validating its potential applications across various cancers.
- Market Potential: As a mainstay therapy for CLL, Venetoclax achieved sales of approximately $2.5 billion in 2024, and the combination therapy with Opaganib is expected to enhance its market competitiveness, addressing the urgent demand for new treatment options.
See More
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- Strategic Partnership: The ongoing partnership with Cumberland Pharmaceuticals for Talicia® aims to enhance RedHill's competitive position in the U.S. market, which is expected to positively impact the company's financial standing and global business operations.
- Operational Efficiency Focus: RedHill is concentrating on improving operational efficiency, intending to optimize internal processes and resource allocation to strengthen its market position in the biopharmaceutical sector, thereby laying a foundation for future growth.
- Clinical Development Programs: The company is advancing multiple key clinical programs, including treatments for COVID-19 and other cancers and inflammatory diseases, demonstrating its ongoing commitment to innovative drug development.
See More
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- Stock Volatility: RedHill Biopharma's stock fell 4.29% to $1.34 on Tuesday after a 36% rally on Monday, indicating potential profit-taking that may affect investor confidence in the short term.
- Development Progress: The company announced advancements for RHB-102 (Bekinda) in multiple gastrointestinal indications, utilizing the FDA's accelerated 505(b)(2) pathway, which aims to address GI side effects associated with GLP-1/GIP receptor agonist therapies, presenting significant market potential.
- Clinical Data Support: Clinical data for RHB-102 comes from the U.S. Phase 3 GUARD gastroenteritis study and the positive Phase 2 IBS-D study, both meeting their primary endpoints, which are expected to provide strong support for FDA approval and potentially reshape the GLP-1 market landscape.
- Market Impact: With up to 50% of patients discontinuing GLP-1 receptor agonists within three months due to side effects, successful development of RedHill's therapy could mitigate the projected $35 billion reduction in GLP-1 market valuations by 2030.
See More
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- Significant Stock Surge: Cyclerion Therapeutics shares rose 44.2% to $1.99 in pre-market trading, reflecting strong market confidence in the company's expanded strategic collaboration with Medsteer, indicating positive investor sentiment towards future growth prospects.
- Deepening Strategic Collaboration: The partnership with Medsteer aims to advance the closed-loop anesthetic platform CYC-126, which is expected to accelerate the product's market entry, thereby enhancing the company's competitive edge in the anesthesia sector.
- Optimistic Market Outlook: With continuous advancements in anesthetic technology, Cyclerion's new platform is poised to meet the increasing medical demand, further driving revenue growth and strengthening its position in the healthcare industry.
- Increased Investor Confidence: The substantial stock price increase not only reflects market approval of the company's strategic direction but may also attract more investor interest, thereby supporting future financing and expansion efforts.
See More
RedHill Biopharma Advances RHB-102 Development, Potentially Mitigating $35 Billion Market Loss
- Clinical Progress: RedHill Biopharma announced advancements in the development of RHB-102 across multiple GI indications, planning to seek FDA approval via the accelerated 505(b)(2) route, which, if approved, could become the first 24-hour oral extended-release antiemetic, significantly enhancing patient treatment experiences.
- Market Potential: The development of RHB-102 aims to address common GI side effects associated with GLP-1/GIP receptor agonist therapies, potentially reducing up to 50% of patients discontinuing treatment within three months, thereby avoiding an estimated $35 billion market loss by 2030.
- Clinical Data Support: RHB-102 has shown positive results in U.S. Phase 3 and Phase 2 clinical trials for acute gastroenteritis and IBS-D, respectively, both meeting their primary endpoints, providing robust clinical data to support FDA approval.
- Intellectual Property Expansion: RedHill has also expanded the intellectual property coverage for RHB-102, ensuring its competitive edge across multiple indications, including GLP-1-associated side effects, further solidifying its position in the biopharmaceutical sector.
See More
RedHill Biopharma Reduces CLL Cells by 50% with Opaganib and Venetoclax Combination
- Significant Efficacy: RedHill Biopharma's study indicates that the combination of opaganib and venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cell counts by 50%, providing new hope for treating venetoclax-resistant CLL patients.
- Mechanism Exploration: Research shows that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cells, and inhibiting SPHK2 may reduce T-cell-induced resistance, offering critical insights for personalized treatment strategies.
- Clinical Prospects: Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials, and is currently undergoing preliminary clinical trials in combination with darolutamide, further validating its potential across various cancers.
- Market Potential: As a mainstay therapy for CLL, venetoclax achieved sales of approximately $2.5 billion in 2024, and the combination with opaganib is expected to enhance its efficacy, strengthening RedHill's competitive position in the oncology market.
See More
RedHill Biopharma's Opaganib Reduces CLL Cells by 50% in Combination with Venetoclax
- Efficacy Breakthrough: RedHill Biopharma's study reveals that combining Opaganib with Venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cell counts by 50%, providing new treatment hope for patients resistant to Venetoclax.
- Mechanism Exploration: Research indicates that SPHK2 is overexpressed in venetoclax-resistant cancer cells, and inhibiting SPHK2 may not only reduce T-cell-induced resistance but also resensitize previously resistant cells, thereby improving treatment outcomes for patients.
- Clinical Prospects: Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials, and is currently undergoing preliminary clinical trials in combination with Darolutamide, further validating its potential applications across various cancers.
- Market Potential: As a mainstay therapy for CLL, Venetoclax achieved sales of approximately $2.5 billion in 2024, and the combination therapy with Opaganib is expected to enhance its market competitiveness, addressing the urgent demand for new treatment options.
See More
RedHill Biopharma Regains Nasdaq Compliance with Stockholders' Equity Exceeding $2.5 Million
- Compliance Regained: On November 26, 2025, RedHill Biopharma confirmed it has regained compliance with Nasdaq Listing Rule 5550(b)(1), demonstrating stockholders' equity exceeding $2.5 million, which marks a significant milestone in the company's strategic initiatives for 2025.
- Strategic Partnership: The ongoing partnership with Cumberland Pharmaceuticals for Talicia® aims to enhance RedHill's competitive position in the U.S. market, which is expected to positively impact the company's financial standing and global business operations.
- Operational Efficiency Focus: RedHill is concentrating on improving operational efficiency, intending to optimize internal processes and resource allocation to strengthen its market position in the biopharmaceutical sector, thereby laying a foundation for future growth.
- Clinical Development Programs: The company is advancing multiple key clinical programs, including treatments for COVID-19 and other cancers and inflammatory diseases, demonstrating its ongoing commitment to innovative drug development.
See More
