Key Takeaways
- Bayer partnership milestone: Recruitment launched for Phase 2 trial combining RedHill’s opaganib with Bayer’s darolutamide in advanced prostate cancer.
- Pipeline boost: FDA clears RedHill’s MAP-positive Crohn’s study, a first-of-its-kind precision medicine approach.
- Financial turnaround: Revenues surged 59% YoY to $4.1M in H1 2025, with gross profit doubling and cash burn reduced by 19%.
Bayer-Supported Trial Expands Opaganib’s Potential
RedHill Biopharma’s collaboration with Bayer has taken center stage with the initiation of patient recruitment for a Phase 2 combination trial of opaganib and darolutamide in advanced prostate cancer. Darolutamide, marketed by Bayer under the brand name Nubeqa®, is an established androgen receptor inhibitor, and combining it with RedHill’s novel oral sphingosine kinase-2 (SK2) inhibitor opaganib could unlock new treatment pathways for difficult-to-treat cancers. This marks a major validation of RedHill’s science by one of the global leaders in oncology.
Expanding Pipeline with FDA Alignment
In addition to its oncology advances with Bayer, RedHill has secured FDA support to launch the first-ever clinical study of RHB-204 in MAP-positive Crohn’s disease patients. This precision-driven design could reshape inflammatory bowel disease care by targeting a defined patient population, reducing trial costs, and accelerating timelines.
Commercial Momentum and Global Expansion
RedHill’s flagship product Talicia® for H. pylori infection continued its growth trajectory, achieving higher U.S. revenues with a streamlined sales team. With formulary coverage expanded to 204M lives and a UK Marketing Authorization Application imminent, Talicia is positioned for significant international expansion. Initial ex-U.S. milestone and royalty payments have already begun flowing, validating the product’s global potential.
Financial Stability and Strategic Deals
RedHill reported 59% revenue growth to $4.1M in H1 2025, doubling gross profit while cutting cash burn by 19%. Non-dilutive funding through partnerships is driving financial resilience, highlighted by a $60M out-licensing deal for RHB-102 with Hyloris Pharmaceuticals. Together with Bayer’s backing and ongoing licensing discussions, RedHill is building a sustainable model of growth.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company focused on gastrointestinal, inflammatory, and infectious diseases, with a growing footprint in oncology. Its late-stage development programs and commercial products, including Talicia®, RHB-204, and opaganib, are supported by global partnerships with leaders such as Bayer.
About Bayer
Bayer AG is a global life sciences company with core competencies in healthcare and agriculture. Through its Pharmaceuticals division, Bayer delivers innovative treatments in oncology, cardiology, and women’s health. With a strong portfolio that includes blockbuster therapies such as darolutamide (Nubeqa®), Bayer continues to invest in novel collaborations to address high unmet medical needs worldwide.
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