Protagonist Therapeutics Inc. (PTGX) witnessed a substantial pre-market surge on Monday, following the announcement of positive topline results from the Phase 3 VERIFY study of its investigational drug rusfertide in patients with polycythemia vera (PV), a rare form of blood cancer.
The study met its primary endpoint, with a significantly higher proportion of clinical responders among rusfertide-treated patients (77%) compared to those who received placebo (33%) during weeks 20-32. Additionally, all four key secondary endpoints were achieved, including the pre-specified primary endpoint for European Union (EU) regulators and patient-reported outcomes.
Notably, rusfertide was generally well-tolerated, with no new safety findings observed in the study. Protagonist will earn a $25 million milestone payment from its collaboration partner Takeda following these positive results. The companies plan to work together to submit the findings to regulatory agencies.
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