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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 Outlines Pipeline and Financial Strategy at JPMorgan Healthcare Conference
PTGX
Product Launch
New Projects/Investments
Guidance Update
  • Protagonist Therapeutics anticipates potential commercial launches this year for two partnered assets: Icotrokinra (branded as Icotide) with Johnson & Johnson for psoriasis, and Rusfertide with Takeda for Polycythemia Vera (PV).
  • The company announced new development candidates, including PN-458, a dual GLP-1/GIP agonist for obesity, and PN-8047, an oral hepcidin functional mimetic, alongside existing programs like PN-881 (oral IL-17 antagonist) and PN-477 (oral triple agonist for obesity).
  • Protagonist reported a strong financial position, ending Q3 last year with approximately $679 million in cash, projected to fund operations through the end of 2028, excluding future milestones and royalties from partnered assets.
  • The company detailed potential future revenues from partnerships: Icotide offers up to $600 million in future milestones and royalties averaging 7.25% (up to $4 billion annual sales). For Rusfertide, opting out of the co-co arrangement could yield a $400 million one-time fee, higher milestones, and royalties averaging 21% (up to $1.5 billion annual sales).
2 days ago
Protagonist Therapeutics Details 2026 Product Launches, Pipeline Expansion, and Financial Outlook
PTGX
Product Launch
New Projects/Investments
Guidance Update
  • Protagonist Therapeutics anticipates potential approvals and launches in 2026 for two key partnered assets: Icotide (with J&J) for psoriasis, with a consensus forecast of $10 billion+ in total market value and Protagonist eligible for $600 million in milestones and 7.25%-10% royalties; and Rusfertide (with Takeda) for Polycythemia Vera, with Takeda estimating $1-$2 billion peak revenue potential, and Protagonist potentially opting out of co-commercialization for a $400 million fee and 14%-29% royalties.
  • The company reported a strong cash position of approximately $679 million at the end of Q3 2025, providing a cash runway through the end of 2028, which explicitly excludes future milestone, fee, or royalty income from its partnered assets.
  • Protagonist is expanding its fully-owned R&D pipeline with new development candidates, including PN-881 (oral IL-17 antagonist) with Phase I study completion by mid-2026, PN-8047 (oral hepcidin mimetic) with Phase I initiation by year-end 2026, and new obesity programs PN-477 (oral triple agonist) and PN-458 (dual GLP-1/GIP agonist) with Phase I studies expected in 2026.
2 days ago
Protagonist Therapeutics Details Upcoming Product Launches and Financial Outlook
PTGX
Product Launch
New Projects/Investments
Guidance Update
  • Protagonist Therapeutics anticipates potential commercial launches in 2026 for two partnered assets: Icotide (with J&J) for psoriasis and Rusfertide (with Takeda) for Polycythemia Vera.
  • The company ended Q3 last year with approximately $679 million in cash, which is projected to fund operations through the end of 2028, excluding future milestones or royalties from partnered products.
  • For Icotide, Protagonist is eligible for over $600 million in future development and sales milestones and royalty rates averaging 7.25% on annual revenues up to $4 billion, increasing to 10% thereafter.
  • For Rusfertide, Protagonist is considering opting out of the co-commercialization arrangement, which would result in a $400 million one-time opt-out fee, approximately $100 million in development milestones, and royalty rates averaging 21% up to $1.5 billion annual sales, progressing to 29% for higher sales.
  • Protagonist also announced new development candidates, PN-458 (a dual GLP-1/GIP agonist) and PN-8047 (an oral hepcidin functional mimetic), expanding its pipeline in obesity and heme spaces.
2 days ago
Protagonist Therapeutics Provides Pipeline and Regulatory Update
PTGX
Product Launch
New Projects/Investments
  • Protagonist Therapeutics submitted a New Drug Application (NDA) for icotrokinra for plaque psoriasis in July 2025 and a Marketing Authorization Application (MAA) in September 2025.
  • The company also submitted an NDA for rusfertide for Polycythemia Vera (PV) in December 2025, with potential FDA approval and commercial launch anticipated in 2H 2026.
  • In Q4 2025, Protagonist Therapeutics initiated Phase 1 for PN-881 (oral IL-17 antagonist) and nominated PN-8047 (oral hepcidin functional mimetic) and PN-458sc/o (dual GLP-1R/GIPR agonist) as new development candidates.
3 days ago
Protagonist Therapeutics Provides Update on Late-Stage Pipeline and Commercialization Timelines
PTGX
Product Launch
New Projects/Investments
  • Protagonist Therapeutics (PTGX) has two potential blockbuster drugs, Icotrokinra and Rusfertide, both with NDA filings submitted in 2025 and anticipated commercial launches in 2H 2026.
  • Icotrokinra, an oral IL-23R antagonist, had its NDA filed for plaque psoriasis in July '25 and MAA submitted in September '25, with Phase 3 studies ongoing for psoriatic arthritis, ulcerative colitis, and Crohn's disease.
  • Rusfertide, a hepcidin mimetic for Polycythemia Vera, had its NDA submitted in December '25 after positive Phase 3 VERIFY study results and holds Orphan Drug, Fast Track, and Breakthrough Therapy designations.
  • The company stands to receive substantial milestone payments from partnerships, including $205M in potential development milestones for Icotrokinra and up to $1,675M (opt-out scenario) for Rusfertide, alongside up to $1.2 Billion in potential sales milestones.
  • Protagonist's pipeline also includes PN-881, an oral IL-17 antagonist that initiated Phase 1 in Q4 '25 and targets a $17B+ market opportunity, and other early-stage programs.
4 days ago
Protagonist and Takeda Announce NDA Submission for Rusfertide
PTGX
Product Launch
New Projects/Investments
  • Takeda and Protagonist Therapeutics have submitted a New Drug Application (NDA) to the U.S. FDA for rusfertide, a first-in-class investigational hepcidin mimetic for the treatment of adults with polycythemia vera (PV).
  • The NDA includes positive 52-week data from the Phase 3 VERIFY study, which met its primary and all four key secondary endpoints, demonstrating durable hematocrit control and improved patient-reported outcomes.
  • Rusfertide has received Breakthrough Therapy, Orphan Drug, and Fast Track Designations from the U.S. FDA.
  • The NDA submission triggers a 120-day period, after which Protagonist can exercise an opt-out right, potentially leading to up to $400 million in opt-out payments and 14-29% tiered royalty rates on worldwide net sales if exercised.
Jan 5, 2026, 12:00 PM
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