Rhine Pharma

Executive Summary

Rhine Pharma, a German biotech founded in 2018, is dedicated to expanding global access to targeted theranostics using generator-produced radioisotopes. The company focuses on developing radiopharmaceuticals based on Rhenium-188 (Re-188) and Technetium-99m (Tc-99m), which offer advantages in availability and cost-effectiveness compared to cyclotron-produced isotopes. Its lead program is a matched pair of diagnostic and therapeutic agents targeting PSMA-positive prostate cancer: a Tc-99m-labeled imaging agent for SPECT/CT and a Re-188-labeled therapeutic agent for radionuclide therapy. This theranostic approach enables precise patient selection and personalized treatment, potentially improving outcomes and reducing side effects. Rhine Pharma is currently in Phase 3 clinical development for its PSMA-targeted theranostic pair. The study aims to demonstrate the efficacy and safety of Re-188-PSMA therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). If successful, the company plans to submit regulatory filings in Europe and the US, leveraging the convenience of generator-based isotope supply to offer a more accessible alternative to existing therapies like Lu-177-PSMA. The technology also holds promise for other cancer types expressing PSMA. With a differentiated value proposition and a clear path to market, Rhine Pharma represents a compelling opportunity in the precision oncology space.

Upcoming Catalysts (preview)

• Q1 2027Phase 3 Top-Line Data Readout for Re-188-PSMA Therapy65% success
• Q3 2027Regulatory Submission (NDA/MAA) for PSMA Theranostic Pair60% success
• H2 2026Commercial Partnership for Ex-US Distribution70% success