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Protagonist Therapeutics (PTGX)

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Earnings summaries and quarterly performance for Protagonist Therapeutics.

Recent press releases and 8-K filings for PTGX.

Protagonist Therapeutics' Rusfertide Shows Sustained Hematocrit Control and Reduced Phlebotomy in PV
PTGX
New Projects/Investments
  • Rusfertide, a hepcidin mimetic peptide, demonstrated sustained control of hematocrit levels below 45% and significantly reduced the need for therapeutic phlebotomy in patients with polycythemia vera (PV) through 52 weeks in the Phase 3 VERIFY study.
  • In the VERIFY study, 61.9% of patients continuously treated with rusfertide avoided phlebotomy eligibility, and those who switched from placebo achieved rapid and durable hematocrit reduction, with up to 77.9% becoming phlebotomy ineligible.
  • Long-term extension studies further corroborated rusfertide's sustained efficacy and safety, showing a 13-fold reduction in annual phlebotomy rates over four years.
  • Rusfertide, a weekly self-injected peptide mimetic, was well tolerated and offers potential for improved PV management by controlling hematocrit and reducing cardiovascular risks, though it is not yet FDA approved.
Dec 6, 2025, 3:22 PM
Protagonist Therapeutics Reports Q3 2025 Financial Results and Corporate Update
PTGX
Earnings
Guidance Update
New Projects/Investments
  • Protagonist Therapeutics reported a net loss of ($39.3) million or ($0.62) per basic and diluted share for the three months ended September 30, 2025.
  • As of September 30, 2025, the company held $678.8 million in cash, cash equivalents, and marketable securities, which is anticipated to provide a cash runway through at least the end of 2028.
  • A New Drug Application (NDA) for icotrokinra was submitted to the U.S. FDA in July, followed by an EMA application in September.
  • Rusfertide was granted Breakthrough Therapy Designation by the U.S. FDA, and its U.S. NDA filing is expected in Q4 2025.
  • The first patient has been dosed in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist.
Nov 6, 2025, 9:19 PM
Protagonist Therapeutics Discusses Positive Rusfertide Data, Icotrochra Progress, and Advancing New Pipeline Assets
PTGX
New Projects/Investments
Product Launch
Guidance Update
  • Protagonist's rusfertide, for polycythemia vera, has outstandingly positive Phase 3 data and received Breakthrough Designation. The company has 9 to 12 months to decide on an opt-out with Takeda, which could yield $425 million and 14% to 29% royalties on projected $1 billion to $2 billion peak sales.
  • Protagonist's partnered asset, icotrochra (oral IL-23 blocker) with J&J, has an NDA filed for psoriasis and is progressing in other indications. J&J guided 2027 sales to $1.4 billion, with royalties for Protagonist ranging from 6% to 10% on sales potentially exceeding $4 billion.
  • Protagonist is advancing new pipeline assets, including PN881 (oral IL-17 blocker) and PN477 (oral triple G for obesity), with Phase 1 studies for both expected to begin in Q4 2025. The company plans to develop both oral and injectable versions of PN477 for the obesity market.
Sep 3, 2025, 3:00 PM