Protagonist Ther Stock Price, News & Analysis

Protagonist Therapeutics (PTGX) has presented new clinical data for two key psoriasis treatments at the 2025 SID Annual Meeting. The Phase 3 ICONIC-TOTAL study of icotrokinra, their first-in-class oral IL-23 receptor antagonist, showed significant efficacy in treating difficult-to-treat psoriasis areas. At Week 16, the drug achieved:

- 57% overall skin clearance rate vs 6% for placebo
- 66% scalp psoriasis clearance vs 11% for placebo
- 77% genital psoriasis clearance vs 21% for placebo
- 42% hand/foot psoriasis clearance vs 26% for placebo

The company also presented preclinical data for PN-881, their novel oral IL-17 pathway inhibitor, showing promising potency and stability. PN-881 demonstrated superior potency compared to secukinumab and is scheduled to begin human clinical trials in Q4 2025.

Protagonist Therapeutics (PTGX) reported Q1 2025 financial results and significant clinical progress. The company announced positive Phase 3 VERIFY trial results for rusfertide in polycythemia vera, with data to be presented at ASCO's plenary session on June 1st. Their IL-23 receptor antagonist icotrokinra showed positive results in both Phase 3 ICONIC-LEAD trial for plaque psoriasis and Phase 2b ANTHEM trial for ulcerative colitis. Financially, PTGX reported $697.9M in cash and equivalents, providing runway through 2028, though posted a Q1 net loss of $11.7M ($0.19 per share) compared to prior year's income of $207.3M. License and collaboration revenue decreased to $28.3M from $255.0M in Q1 2024, mainly due to prior year's Takeda collaboration agreement.

Protagonist Therapeutics (PTGX) announced that results from its VERIFY Phase 3 study of Rusfertide for treating Polycythemia Vera (PV) will be presented at the ASCO Annual Meeting Plenary Session. The presentation will be delivered by Dr. Andrew T. Kuykendall from Moffitt Cancer Center on June 1, 2025, at 2:09 PM CDT in McCormick Place, Hall B1.

The VERIFY study is a double-blind, placebo-controlled Phase 3 clinical trial evaluating Rusfertide's effectiveness in PV treatment. The selection for a plenary presentation at ASCO, scheduled for May 30 - June 3, 2025, represents a significant platform for sharing these important clinical findings.

Protagonist Therapeutics (PTGX) has announced the granting of an equity inducement award to a new employee on April 15, 2025. The award, issued under the Company's Amended and Restated 2018 Inducement Plan, consists of options to purchase 20,000 shares of common stock at an exercise price of $46.95 per share, matching the closing price on Nasdaq on the grant date.

The options feature a four-year vesting schedule, with 25% vesting after the first year and the remaining portion vesting in equal monthly installments over the subsequent three years. The award was approved by the Company's Compensation Committee and granted as a material inducement for employment in accordance with Nasdaq Marketplace Rule 5635(c)(4).

Protagonist Therapeutics announced promising Phase 3 trial results for icotrokinra, a first-in-class oral peptide targeting IL-23 receptor for moderate-to-severe plaque psoriasis. The ICONIC-LEAD study's adolescent cohort showed remarkable efficacy at Week 16, with 84.1% achieving clear/almost clear skin (IGA 0/1) and 70.5% reaching PASI 90, compared to 27.3% and 13.6% in placebo group respectively.

Results improved further by Week 24, with 75% of adolescents achieving completely clear skin (IGA 0) and 63.6% reaching PASI 100. The safety profile was favorable, with fewer adverse events in the treatment group (50%) compared to placebo (73%). This marks the first Phase 3 study evaluating a systemic therapy simultaneously in both adolescents and adults with plaque psoriasis.

Protagonist Therapeutics has been named to Fast Company's World's Most Innovative Companies for 2025, securing a position among the top 5 Most Innovative Biotechnology companies. The recognition highlights their pioneering work in peptide-based drug development.

The company's achievements include multiple breakthrough candidates:

• Rusfertide: A hepcidin mimetic with successful Phase 3 trials for polycythemia vera, developed with Takeda Pharmaceuticals
• Icotrokinra (JNJ-2113): The first oral IL-23 receptor antagonist, showing efficacy in Phase 3 psoriasis trials and Phase 2 ulcerative colitis trials
• PN-881: An oral IL-17 antagonist advancing to first-in-human trials
• An anti-obesity program focusing on oral alternatives to injectables

The company maintains strong financial health with a cash runway through at least 2028. Both Rusfertide and Icotrokinra are expected to file NDAs with the FDA this year.

Protagonist Therapeutics (PTGX) has announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first targeted oral peptide selectively blocking the IL-23 receptor, in adults with moderately to severely active ulcerative colitis.

The study, conducted with Johnson & Johnson, met its primary endpoint of clinical response across all dose groups. The highest dose achieved a 63.5% response rate at Week 12 (vs 27.0% placebo) and a 30.2% clinical remission rate (vs 11.1% placebo), with both results being statistically significant (p<0.001). Clinical remission and response rates continued improving through Week 28.

Icotrokinra demonstrated favorable safety, with adverse events comparable between treatment and placebo groups. The drug's potential as a once-daily oral treatment could transform the UC treatment landscape, with plans for advancement into more advanced clinical studies for both ulcerative colitis and Crohn's disease.

Protagonist Therapeutics announced breakthrough results for icotrokinra (JNJ-2113), a first-in-class oral peptide for moderate-to-severe plaque psoriasis (PsO). In the Phase 3 ICONIC-LEAD study, the once-daily pill demonstrated remarkable efficacy with 46% of patients achieving completely clear skin (IGA 0) at Week 24.

Key findings at Week 24 showed 74% of patients achieved clear/almost clear skin (IGA 0/1) and 65% reached PASI 90. The drug demonstrated a favorable safety profile, with adverse events comparable to placebo (49% in both groups).

Additionally, in the ICONIC-ADVANCE 1&2 studies, icotrokinra showed superiority to deucravacitinib, meeting all primary and secondary endpoints. Based on these positive results, a groundbreaking head-to-head study (ICONIC-ASCEND) will compare icotrokinra against injectable biologic ustekinumab, potentially establishing a new standard in PsO treatment.

Protagonist Therapeutics (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announced positive topline results from their Phase 3 VERIFY study of rusfertide in polycythemia vera (PV) patients. The study achieved its primary endpoint with 77% of rusfertide-treated patients showing clinical response compared to 33% in the placebo group.

The trial met all four key secondary endpoints, including the EU primary endpoint showing 0.5 phlebotomies per patient in the rusfertide arm versus 1.8 in the placebo arm. Rusfertide, a first-in-class hepcidin mimetic peptide therapeutic with FDA Orphan Drug and Fast Track designations, demonstrated favorable safety with mainly grade 1-2 injection site reactions.

Following these positive results, Protagonist will receive a $25 million milestone payment from Takeda upon completion of the VERIFY clinical study report.