Takeda and Protagonist Submit New Drug Application for Rusfertide
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
0mins
Should l Buy PTGX?
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: 80.670
Low
65.00
Averages
94.54
High
115.00
Current: 80.670
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.
Protagonist Therapeutics CMO Sells Shares in Major Transaction
- Executive Stock Sale: Protagonist Therapeutics' Chief Medical Officer Arturo Molina sold 9,514 shares on January 20, 2026, for approximately $784,700, marking his largest direct market sale to date, surpassing his previous maximum of 2,712 shares, indicating confidence in the market.
- Shareholding Status: Post-transaction, Molina retains 97,266 shares valued at $8.11 million, demonstrating his ongoing investment in the company, although the sale was primarily for tax withholding purposes.
- Company Financial Overview: Protagonist Therapeutics boasts a market capitalization of $5.11 billion, with a 120.48% stock price increase over the past year, reflecting strong market expectations for future growth, particularly as it expands its clinical trial pipelines.
- Analyst Rating Support: While Molina's sale should not influence investment decisions, the majority of Wall Street analysts rate the company as a “strong buy,” and its high price-to-earnings ratio of 113.68 suggests optimistic growth expectations from the market.
See More
Protagonist Therapeutics Executive Sells Shares
- Executive Sell-off: Arturo Molina, Chief Medical Officer of Protagonist Therapeutics, sold 9,514 shares on January 20, 2026, generating approximately $784,700 at a price of $82.48 per share, reducing his holdings from 106,780 to 97,266 shares, representing an 8.91% decrease.
- Market Reaction Analysis: Although Molina's sale was primarily for tax withholding purposes, the majority of Wall Street analysts rate Protagonist's stock as a 'strong buy', with a high price-to-earnings ratio of 113.68, indicating strong growth expectations from the market.
- Clinical Trial Progress: At the early January 2026 J.P. Morgan Healthcare Conference, Protagonist highlighted significant expansion in its clinical trial pipelines, particularly with two key pharmaceutical products reaching advanced clinical development stages, backed by major firms like Johnson & Johnson.
- Stock Performance Review: Protagonist's stock soared approximately 123% in 2025, and with robust support from Wall Street and institutional investors, it appears to be an ideal option for those seeking portfolio exposure in the medical field.
See More
Protagonist CMO Sells 9,514 Shares for $784K to Cover Taxes
- Transaction Overview: Arturo Molina, Chief Medical Officer of Protagonist Therapeutics, sold 9,514 shares on January 20, 2026, for approximately $784,700, marking his largest direct open-market sale to date, surpassing his previous maximum of 2,712 shares.
- Post-Transaction Holdings: Following this sale, Molina retains 97,266 shares, valued at about $8.11 million, indicating his continued confidence in the company’s prospects, despite the sale being primarily for tax withholding purposes.
- Market Performance: Protagonist has a market capitalization of $5.11 billion, with a remarkable 120.48% increase in stock price over the past year, reflecting strong market expectations for future growth, particularly as it expands its clinical trial pipelines and advances key pharmaceutical products.
- Analyst Ratings: While Molina's stock sale is not expected to influence investment decisions, the majority of Wall Street analysts rate Protagonist as a “strong buy,” and its high price-to-earnings ratio of 113.68 suggests significant growth potential anticipated by the market.
See More
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.
See More
S&P 500 Futures Rise in Pre-Market Trading; Blue Hat Interactive and Sunoco Take the Lead
Market Opening: U.S. stock markets are set to open in two hours.
Blue Hat Interactive Performance: Blue Hat Interactive Entertainment Technology (BHAT) saw a 9.5% increase in pre-market trading.
Sunoco L.P. Performance: Sunoco L.P. (SUN) experienced a 7.4% rise in pre-market trading.
Overall Market Sentiment: The pre-market gains indicate positive sentiment among investors ahead of the market opening.
See More
Protagonist and Takeda Present New 52-Week Results for PV Study at ASH
- Sustained Efficacy: In the 52-week VERIFY study, 61.9% of polycythemia vera patients maintained absence of phlebotomy eligibility while treated with rusfertide, demonstrating the drug's long-term efficacy and safety, which could redefine clinical treatment standards.
- Reduced Treatment Burden: In the THRIVE study, the annualized phlebotomy rate for patients dropped from 9.2 to 0.7, indicating that rusfertide significantly alleviates treatment burdens and enhances quality of life, addressing a critical unmet medical need.
- Successful Study Design: The VERIFY study successfully met its primary and all key secondary endpoints with 293 patients, providing crucial data for clinical decision-making regarding rusfertide's application in polycythemia vera treatment.
- Regulatory Progress: Protagonist and Takeda are preparing to submit a New Drug Application to the FDA, indicating smooth development progress for rusfertide, which may offer new treatment options for polycythemia vera patients and enhance the company's competitive position in the biopharmaceutical sector.
See More
Protagonist Therapeutics CMO Sells Shares in Major Transaction
- Executive Stock Sale: Protagonist Therapeutics' Chief Medical Officer Arturo Molina sold 9,514 shares on January 20, 2026, for approximately $784,700, marking his largest direct market sale to date, surpassing his previous maximum of 2,712 shares, indicating confidence in the market.
- Shareholding Status: Post-transaction, Molina retains 97,266 shares valued at $8.11 million, demonstrating his ongoing investment in the company, although the sale was primarily for tax withholding purposes.
- Company Financial Overview: Protagonist Therapeutics boasts a market capitalization of $5.11 billion, with a 120.48% stock price increase over the past year, reflecting strong market expectations for future growth, particularly as it expands its clinical trial pipelines.
- Analyst Rating Support: While Molina's sale should not influence investment decisions, the majority of Wall Street analysts rate the company as a “strong buy,” and its high price-to-earnings ratio of 113.68 suggests optimistic growth expectations from the market.
See More
Protagonist Therapeutics Executive Sells Shares
- Executive Sell-off: Arturo Molina, Chief Medical Officer of Protagonist Therapeutics, sold 9,514 shares on January 20, 2026, generating approximately $784,700 at a price of $82.48 per share, reducing his holdings from 106,780 to 97,266 shares, representing an 8.91% decrease.
- Market Reaction Analysis: Although Molina's sale was primarily for tax withholding purposes, the majority of Wall Street analysts rate Protagonist's stock as a 'strong buy', with a high price-to-earnings ratio of 113.68, indicating strong growth expectations from the market.
- Clinical Trial Progress: At the early January 2026 J.P. Morgan Healthcare Conference, Protagonist highlighted significant expansion in its clinical trial pipelines, particularly with two key pharmaceutical products reaching advanced clinical development stages, backed by major firms like Johnson & Johnson.
- Stock Performance Review: Protagonist's stock soared approximately 123% in 2025, and with robust support from Wall Street and institutional investors, it appears to be an ideal option for those seeking portfolio exposure in the medical field.
See More
Protagonist CMO Sells 9,514 Shares for $784K to Cover Taxes
- Transaction Overview: Arturo Molina, Chief Medical Officer of Protagonist Therapeutics, sold 9,514 shares on January 20, 2026, for approximately $784,700, marking his largest direct open-market sale to date, surpassing his previous maximum of 2,712 shares.
- Post-Transaction Holdings: Following this sale, Molina retains 97,266 shares, valued at about $8.11 million, indicating his continued confidence in the company’s prospects, despite the sale being primarily for tax withholding purposes.
- Market Performance: Protagonist has a market capitalization of $5.11 billion, with a remarkable 120.48% increase in stock price over the past year, reflecting strong market expectations for future growth, particularly as it expands its clinical trial pipelines and advances key pharmaceutical products.
- Analyst Ratings: While Molina's stock sale is not expected to influence investment decisions, the majority of Wall Street analysts rate Protagonist as a “strong buy,” and its high price-to-earnings ratio of 113.68 suggests significant growth potential anticipated by the market.
See More
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.
See More
S&P 500 Futures Rise in Pre-Market Trading; Blue Hat Interactive and Sunoco Take the Lead
Market Opening: U.S. stock markets are set to open in two hours.
Blue Hat Interactive Performance: Blue Hat Interactive Entertainment Technology (BHAT) saw a 9.5% increase in pre-market trading.
Sunoco L.P. Performance: Sunoco L.P. (SUN) experienced a 7.4% rise in pre-market trading.
Overall Market Sentiment: The pre-market gains indicate positive sentiment among investors ahead of the market opening.
See More
Protagonist and Takeda Present New 52-Week Results for PV Study at ASH
- Sustained Efficacy: In the 52-week VERIFY study, 61.9% of polycythemia vera patients maintained absence of phlebotomy eligibility while treated with rusfertide, demonstrating the drug's long-term efficacy and safety, which could redefine clinical treatment standards.
- Reduced Treatment Burden: In the THRIVE study, the annualized phlebotomy rate for patients dropped from 9.2 to 0.7, indicating that rusfertide significantly alleviates treatment burdens and enhances quality of life, addressing a critical unmet medical need.
- Successful Study Design: The VERIFY study successfully met its primary and all key secondary endpoints with 293 patients, providing crucial data for clinical decision-making regarding rusfertide's application in polycythemia vera treatment.
- Regulatory Progress: Protagonist and Takeda are preparing to submit a New Drug Application to the FDA, indicating smooth development progress for rusfertide, which may offer new treatment options for polycythemia vera patients and enhance the company's competitive position in the biopharmaceutical sector.
See More
