Takeda and Protagonist Submit New Drug Application for Rusfertide
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Takeda (TAK) and Protagonist Therapeutics (PTGX) announced the submission of a new drug application to the FDA seeking approval of rusfertide for the treatment of adults with polycythemia vera. Rusfertide is an investigational first-in-class subcutaneously administered hepcidin mimetic peptide designed to regulate iron homeostasis and red blood cell production to control hematocrit levels in patients with PV.
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Analyst Views on PTGX
Wall Street analysts forecast PTGX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PTGX is 94.54 USD with a low forecast of 65.00 USD and a high forecast of 115.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
13 Analyst Rating
12 Buy
1 Hold
0 Sell
Strong Buy
Current: 81.760
Low
65.00
Averages
94.54
High
115.00
Current: 81.760
Low
65.00
Averages
94.54
High
115.00
About PTGX
Protagonist Therapeutics, Inc. is a biopharmaceutical company focused on peptide therapeutics. The Company’s clinical programs fall into two categories of diseases: hematology and blood disorders, and inflammatory and immunomodulatory diseases. Its two peptides derived from its proprietary discovery technology platform, rusfertide and icotrokinra, are in advanced Phase III clinical development. Its rusfertide (PTG-300) is an injectable hepcidin mimetic in development for the potential treatment of polycythemia vera (PV) and other blood disorders. Icotrokinra, an orally delivered IL-23R specific antagonist for the potential treatment of psoriasis, psoriatic arthritis (PsA), ulcerative colitis and inflammatory bowel disease (IBD) indications. The Company also has a pre-clinical stage oral drug discovery program addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Takeda Submits NDA for Rusfertide, Potential $400M Opt-Out Payment
- NDA Submission: Takeda Pharmaceutical and Protagonist Therapeutics announced the submission of a New Drug Application for rusfertide targeting polycythemia vera, supported by positive 32-week primary analysis and 52-week results from the Phase 3 VERIFY study, which could open new revenue streams for the company.
- Triggering Agreement Terms: The NDA submission initiates a 120-day decision period, during which Protagonist can opt-out within a subsequent 90-day window, potentially securing up to $400 million in opt-out payments, thereby enhancing the company's cash flow.
- Milestone Payments and Royalties: Should Protagonist opt-out, it would be eligible for additional milestone payments and tiered royalty rates of 14-29% on worldwide net sales, significantly boosting its future revenue potential and financial stability.
- Market Reaction: Following the announcement, Takeda's stock traded down 0.13% on the NYSE, while Protagonist's stock rose 0.37% on Nasdaq, reflecting a cautiously optimistic market sentiment regarding the new drug application.
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