Protagonist Therapeutics

PTGX

Market cap $5.89B

OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act.

(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid-2026 Pre-clinical pipeline expanded with novel wholly-owned candidates PN-477, an oral and s.c.

NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with  potential launch this year PN-881 Phase 1 completion expected by mid-2026 NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update. "In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V.

Hedge fund BVF sold 2,560,916 shares of PTGX in the fourth quarter. As a result, the quarter-end position value decreased by $170.12 million.

NEWARK, CA / ACCESS Newswire / February 24, 2026 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that Dinesh V. Patel, Ph.D.

A director for Protagonist Therapeutics sold 20,000 shares for a transaction value of approximately $1.7 million on Feb. 6, 2026. The transaction involved the exercise of stock options, after which the director held zero options.

Arturo Molina sold 9,514 directly on Jan. 20, 2026, generating a transaction value of approximately $784,700 at a reported price of $82.48 per share. This sale represented 8.91% of Dr. Molina's direct holdings, reducing his stake from 106,780 to 97,266 shares.

Protagonist Therapeutics, Inc. (PTGX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

NEWARK, CA / ACCESS Newswire / January 7, 2026 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that Dinesh V. Patel, Ph.D.

OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist”) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults with polycythemia vera (PV). Rusfertide is an investigational first-in-class subcutaneously administered hepcidin mimetic peptide designed to regulate iron homeostasis and red blood.