On Monday, Protagonist Therapeutics, Inc. PTGX and Takeda Pharmaceutical Co Ltd TAK launched topline outcomes for the Section 3 VERIFY examine of rusfertide for polycythemia vera.
Polycythemia vera is a sort of blood most cancers. It causes your bone marrow to make too many pink blood cells.
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The examine met its major endpoint and all 4 key secondary endpoints. Rusfertide is a first-in-class investigational hepcidin mimetic peptide therapeutic, which has acquired FDA Orphan Drug and Quick Observe designations.
Key findings from the examine embrace:
- The examine’s major endpoint was the proportion of sufferers attaining a response, which was outlined because the absence of phlebotomy eligibility.
- The first endpoint of the examine was met, with a considerably increased proportion of scientific responders amongst rusfertide-treated sufferers with PV (77%) in comparison with those that acquired placebo (33%) throughout weeks 20-32.
- The primary key secondary endpoint, which is the pre-specified major endpoint for European Union (EU) regulators, was additionally met, with a imply of 0.5 phlebotomies per affected person within the rusfertide arm in comparison with 1.8 phlebotomies per affected person within the placebo arm throughout weeks 0-32.
- The opposite three pre-specified key secondary endpoints, particularly hematocrit management and patient-reported outcomes utilizing PROMIS Fatigue SF-8a3 and MFSAF TSS-74, had been additionally achieved with statistical significance.
Rusfertide was typically properly tolerated within the Section 3 VERIFY trial, and security was according to earlier rusfertide scientific research. No new security findings had been noticed within the examine.
Underneath the license and collaboration settlement, Protagonist earns a $25 million milestone cost following these outcomes.
Worth Motion: PTGX inventory is down 0.80% at $37.42, and TAK inventory is up 3.96% at $14.98 on the final test Monday.
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