Earnings summaries and quarterly performance for Protagonist Therapeutics.
Executive leadership at Protagonist Therapeutics.
Board of directors at Protagonist Therapeutics.
Research analysts who have asked questions during Protagonist Therapeutics earnings calls.
Chris Bialas
H.C. Wainwright & Co.
2 questions for PTGX
Douglas Tsao
H.C. Wainwright & Co.
2 questions for PTGX
Adam Walsh
Stifel, Nicolaus & Company, Inc.
1 question for PTGX
Anupam Rama
JPMorgan Chase & Co.
1 question for PTGX
Chris Howerton
Jefferies
1 question for PTGX
Chris Marai
Nomura Instinet
1 question for PTGX
Christopher Marai
Nomura Securities Co. Ltd.
1 question for PTGX
George Farmer
Scotiabank
1 question for PTGX
Gobind Singh
BMO Capital Markets
1 question for PTGX
Joe Schwartz
Leerink Partners
1 question for PTGX
Joori Park
Leerink Partners
1 question for PTGX
Joseph Schwartz
Oppenheimer
1 question for PTGX
Recent press releases and 8-K filings for PTGX.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Quarterly earnings call transcripts for Protagonist Therapeutics.
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