Takeda Pharmaceutical Company Limited (TAK) and Protagonist Therapeutics, Inc. (PTGX), Monday announced the submission of a New Drug Application regarding rusfertide for the treatment of adults with polycythemia vera.
The submission is backed by the positive 32-week primary analysis and 52-week results from the Phase 3 VERIFY study, as well as the Phase 2 REVIVE study.
As per an earlier agreement between the companies, the submission of the NDA triggers the start of a 120-day period, after which Protagonist can decide to exercise its opt-out right during a subsequent 90-day period.
If Protagonist opts out, then it would be eligible for upto $400 million in opt-out payments as well as enhanced milestone payments and 14-29 percent tiered royalty rates on worldwide net sales of rusfertide.
In the pre-market hours, TAK is trading at $15.60, down 0.13 percent on the New York Stock Exchange, and PTGX is trading at $87.50, up 0.37 percent on the Nasdaq.
For comments and feedback contact: editorial@rttnews.com
Health News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.