Protagonist Therapeutics, Inc. a clinical-stage biopharmaceutical company, which engages in discovering and developing peptide-based therapeutic drugs to address unmet medical needs. Its product pipeline includes PTG-300, PTG-200, and PN-943. The company was founded by Mark L. Smythe on August 22, 2006 and is headquartered in Newark, CA.
Clinical Trials
47
27 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
25
53.2%
Completed
15
31.9%
Not yet recruiting
2
4.3%
Recruiting
4
8.5%
Terminated
1
2.1%
No approval data available
- Johnson & Johnson received European Commission marketing authorisation for ICOTYDE (icotrokinra), a once-daily oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis in patients aged 12 and older. - The approval covers adults and adolescents weighing at least 40 kg who are candidates for systemic therapy, making icotrokinra the first targeted oral peptide to block the IL-23 receptor. - Across four Phase 3 ICONIC trials in about 2,500 patients, icotrokinra met all primary endpoints, with roughly 70% achieving IGA 0/1 and 55% achieving PASI 90 at Week 16 in head-to-head studies. - Adverse reaction rates were within 1.1% of placebo through Week 16, with no new safety signals through Week 52, and the drug is under additional EMA monitoring.
- Protagonist Therapeutics (PTGX) trades at $147.75, which a Simply Wall St discounted cash flow model estimates is 63.3% below its fair value of $402.82. - The stock carries a high price-to-earnings ratio of 115.3x, signaling an expensive valuation on an earnings basis that contrasts sharply with the cash-flow-based estimate. - The divergence between earnings-based and cash-flow-based signals highlights the uncertainty investors face in weighing the company's current valuation. - The analysis is general in nature, based on historical data and analyst forecasts, and does not constitute a recommendation to buy or sell the stock.
- Royalty Pharma will provide $100 million to Zealand Pharma in exchange for its economic interests related to rusfertide (PTG-300), a potential first-in-class therapy for polycythemia vera. - Rusfertide mimics hepcidin to regulate iron homeostasis and red blood cell production, aiming to help patients achieve sustained hematocrit control via once-weekly subcutaneous self-injection. - The U.S. FDA has set a PDUFA goal date in the third quarter of 2026 for the rusfertide NDA, with Takeda responsible for global commercialization. - Zealand Pharma will redeploy the immediate capital toward growth opportunities under its Metabolic Frontier 2030 strategy.
- Protagonist Therapeutics shares surged 64% over six months, driven by rusfertide's NDA acceptance with priority review for polycythemia vera and a target action date of August 2026. - The FDA approved Icotyde (icotrokinra), the first oral targeted IL-23 receptor peptide inhibitor, for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment to Protagonist. - Protagonist restructured its rusfertide partnership with Takeda, exiting U.S. profit-sharing in exchange for a $400 million upfront payment, up to $775 million in sales milestones, and tiered royalties of 14%-29%. - The company's wholly owned pipeline, including an oral IL-17 antagonist (PN-881) and multiple metabolic candidates, continues to advance toward the clinic.
- Extended 52-week data from the Phase 3 VERIFY study showed 61.9% of polycythemia vera patients treated with rusfertide maintained absence of phlebotomy eligibility from baseline to Week 52. - Patients who crossed over from placebo to rusfertide at 32 weeks achieved a 77.9% response rate, demonstrating consistent efficacy across treatment groups. - Four-year data from the THRIVE extension study revealed a 13-fold reduction in annual phlebotomy rates compared to baseline, with mean rates dropping from 9.2 to 0.7 phlebotomies per year. - Rusfertide maintained a well-tolerated safety profile with primarily grade 1-2 adverse events, supporting Protagonist and Takeda's planned NDA submission to the FDA by end of 2025.
- Protagonist Therapeutics reported $678.8 million in cash reserves as of September 30, 2025, providing financial runway through at least the end of 2028. - The company submitted regulatory applications for icotrokinra to both FDA and EMA for moderate to severe plaque psoriasis treatment, with partner Johnson & Johnson expanding trials into additional indications. - Rusfertide received FDA breakthrough designation for polycythemia vera and will present 52-week Phase 3 VERIFY study results at the American Society of Hematology meeting in December. - The company initiated Phase 1 dosing of PN-881, a first-in-class oral IL-17 peptide antagonist, while advancing triple-GLP/GIP/GCG agonists through IND-enabling studies.
- Johnson & Johnson is reportedly considering a complete acquisition of partner Protagonist Therapeutics, following years of successful collaboration on the first-in-class oral peptide icotrokinra for immune-mediated diseases. - Icotrokinra has demonstrated clinical superiority over competitor deucravacitinib in head-to-head trials and was recently submitted to the FDA for plaque psoriasis approval, with positive data also emerging in ulcerative colitis. - The potential acquisition exemplifies J&J's disciplined "partner, validate, acquire" M&A strategy, which has already delivered significant returns through recent deals including Abiomed, Shockwave Medical, and Intra-Cellular Therapies. - J&J's strategic portfolio reshaping, including the 2023 Kenvue spinoff and planned orthopedics separation, has generated approximately $14 billion in free cash flow in the first three quarters of 2025 to fuel acquisition activities.
- Protagonist Therapeutics' stock jumped 32.92% on October 10, 2025, driven by promising Phase 3 trial results for icotrokinra in plaque psoriasis treatment. - The company reported positive Phase 2b ANTHEM-UC study results showing icotrokinra's safety and efficacy improvements in ulcerative colitis patients. - Strategic partnerships with Johnson & Johnson and Takeda Pharmaceuticals enhance the company's global market reach and regulatory approval prospects. - Multiple analysts initiated coverage with 'Overweight' ratings, reflecting growing confidence in Protagonist's therapeutic pipeline and commercial potential.
- Johnson & Johnson is reportedly in discussions to acquire Protagonist Therapeutics, sending PTGX shares soaring over 30% on Friday despite no confirmed deal details. - The potential acquisition follows positive Phase IIb trial results for Icotrokinra, showing 30.2% clinical remission in ulcerative colitis patients versus 11.1% placebo response. - Icotrokinra will advance to Phase III trials targeting moderate-to-severe active ulcerative colitis in adults and adolescents, with completion expected by 2028. - The move represents Johnson & Johnson's continued strategic expansion through biotech acquisitions, following its $14.6 billion purchase of Intra-Cellular Therapies earlier this year.
- Johnson & Johnson is in discussions to acquire Protagonist Therapeutics, which has a market capitalization of $4.2 billion as of Thursday's close. - The companies are already collaborating on icotrokinra, an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis. - J&J currently holds exclusive commercialization rights for the drug and owns nearly 4% of Protagonist's shares. - Protagonist's stock surged more than 30% following news of the potential acquisition talks.
