On Monday, Protagonist Therapeutics, Inc. ( PTGX ) and Takeda Pharmaceutical Co Ltd ( TAK ) released topline results for the Phase 3 VERIFY study of rusfertide for polycythemia vera.

Polycythemia vera is a type of blood cancer. It causes your bone marrow to make too many red blood cells.

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The study met its primary endpoint and all four key secondary endpoints. Rusfertide is a first-in-class investigational hepcidin mimetic peptide therapeutic, which has received FDA Orphan Drug and Fast Track designations.

Key findings from the study include:

The study’s primary endpoint was the proportion of patients achieving a response, which was defined as the absence of phlebotomy eligibility.

The primary endpoint of the study was met, with a significantly higher proportion of clinical responders among rusfertide-treated patients with PV (77%) compared to those who received placebo (33%) during weeks 20-32.

The first key secondary endpoint, which is the pre-specified primary endpoint for European Union (EU) regulators, was also met, with a mean of 0.5 phlebotomies per patient in the rusfertide arm compared to 1.8 phlebotomies per patient in the placebo arm during weeks 0-32.

The other three pre-specified key secondary endpoints, namely hematocrit control and patient-reported outcomes using PROMIS Fatigue SF-8a3 and MFSAF TSS-74, were also achieved with statistical significance.

Rusfertide was generally well tolerated in the Phase 3 VERIFY trial, and safety was in line with previous rusfertide clinical studies. No new safety findings were observed in the study.

Under the license and collaboration agreement, Protagonist earns a $25 million milestone payment following these results.

Price Action: PTGX stock is down 0.80% at $37.42, and TAK stock is up 3.96% at $14.98 at the last check Monday.

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