Protagonist Ther Stock Price, News & Analysis

Takeda (NYSE:TAK) and Protagonist announced submission of a New Drug Application (NDA) to the FDA on January 5, 2026 seeking approval of rusfertide for adults with polycythemia vera (PV). The NDA includes 52-week data from the Phase 3 VERIFY study, which met the primary endpoint and all four key secondary endpoints, showing durable hematocrit control, reduced phlebotomy needs and improved patient-reported outcomes.

Rusfertide is a first-in-class subcutaneous hepcidin mimetic and has received Breakthrough Therapy, Orphan Drug and Fast Track designations. Under the January 2024 collaboration, the NDA filing starts a 120-day period then a 90-day opt-out decision window for Protagonist, with up to $400 million in opt-out payments and 14–29% tiered royalties possible.

Takeda (NYSE:TAK) and Protagonist presented 52-week VERIFY and four-year THRIVE data showing durable hematocrit control with rusfertide in polycythemia vera (PV).

Key results: 61.9% of patients on rusfertide maintained absence of phlebotomy eligibility through Week 52; 77.9% of placebo-to-rusfertide crossovers achieved response at Weeks 40–52; mean hematocrit stayed 43% through Week 52. Long‑term data showed a >13‑fold reduction in annual phlebotomy rate (from 9.2 to 0.7 phlebotomies/year). Rusfertide was generally well tolerated with mostly grade 1–2 events.

Protagenic Therapeutics (Nasdaq:PTGX) received a Nasdaq non-compliance notice dated November 27, 2025, citing failure to meet Listing Rule 5550(b)(1) (minimum $2.5 million stockholders' equity) and Rule 5250(c)(1) (timely periodic filings).

Nasdaq concluded the Company's Transition Report on Form 10-QT for the period ended June 30, 2025 showed stockholders' equity below the $2.5 million threshold, and the delayed Form 10-Q for the quarter ended September 30, 2025 is a separate basis for non-compliance. Under Rule 5815 the Staff issued a delisting determination. The Company expects to file the Form 10-Q imminently and will request a hearing and an automatic 15-calendar-day stay, and may request an extended stay pending the Panel decision.

Protagonist (Nasdaq:PTGX) reported Q3 2025 results and provided program updates on November 6, 2025. Cash, cash equivalents and marketable securities were $678.8M as of September 30, 2025, expected to fund operations through at least end of 2028.

Key development milestones: NDA (July) and EMA (Sept) submissions for icotrokinra in moderate-to-severe plaque psoriasis; rusfertide granted FDA Breakthrough Therapy designation with a Takeda NDA expected in Q4 2025 and 52-week VERIFY data to be presented at ASH in December; first subject dosed in Phase 1 for oral IL-17 antagonist PN-881; PN-477sc and PN-477o progressing IND-enabling with clinical starts expected in 2026; oral hepcidin candidate nomination expected by year-end.

Protagonist Therapeutics (NASDAQ:PTGX) will present clinical data on rusfertide at the 67th ASH Annual Meeting in Orlando, Dec 6-9, 2025.

Four presentations highlight the Phase 3 VERIFY randomized study (durability of response and safety through week 52; patient-reported outcomes; dermatologic observations) and initial results from the Phase 2 THRIVE extension study on long-term rusfertide treatment.

Presentation dates range Dec 6–8, 2025, with authors from Moffitt, Princess Margaret, OHSU, and MD Anderson.

Protagonist (NASDAQ:PTGX) reported updated clinical data for icotrokinra presented October 2025 showing sustained benefit across ulcerative colitis and plaque psoriasis studies. In Phase 2b ANTHEM-UC, icotrokinra 400 mg QD produced 31.7% clinical remission and 38.1% endoscopic improvement at Week 28 versus placebo 9.5% and 11.1%, respectively. Results support Phase 3 ICONIC-UC and Phase 2b/3 ICONIC-CD protocols initiated by Johnson & Johnson. In Phase 3 ICONIC-TOTAL, site-specific psoriasis clearance was high and durable: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, and overall 67% IGA 0/1 maintained through Week 52, with similar safety profiles through Week 52 versus Week 16.

Protagonist (NASDAQ:PTGX) reported additional Week 12 data from the Phase 2b ANTHEM-UC study of oral icotrokinra, a selective IL-23 receptor blocker, in moderately to severely active ulcerative colitis.

Key Week 12 highlights: the study met its primary endpoint with all once-daily dose groups showing clinical response; the 400 mg dose achieved a 63.5% clinical response vs 27% placebo. At the highest dose, 36.5% showed endoscopic improvement and 30.2% achieved clinical remission. Adverse event rates were similar to placebo through Week 12. Registrational Phase 3 UC and Phase 2b/3 Crohn's studies are anticipated to begin patient enrollment in Q4 2025; an NDA for plaque psoriasis was submitted in July 2025.

Protagonist Therapeutics (NASDAQ:PTGX) presented significant clinical data for two key products at the EADV 2025 Congress. Their lead candidate icotrokinra, a first-in-class oral peptide targeting IL-23 receptor, demonstrated superior efficacy compared to deucravacitinib in Phase 3 ICONIC-ADVANCE studies for plaque psoriasis. The drug showed sustained skin clearance through Week 52 in both adults and adolescents in the ICONIC-LEAD study.

Additionally, the company presented preclinical data for PN-881, their novel oral IL-17 pathway targeting peptide, which showed promising potency and efficacy. PN-881 demonstrated in vitro potency comparable to bimekizumab and 70-fold superior potency to secukinumab. A Phase 1 clinical trial for PN-881 is expected to begin dosing in the coming weeks.

Protagonist Therapeutics (NASDAQ:PTGX) announced an upcoming presentation of Phase 2b ANTHEM-UC trial data for icotrokinra in ulcerative colitis at the United European Gastroenterology Week (UEGW) 2025 in Berlin. The presentation will focus on the 12-week results of this randomized, double-blind, placebo-controlled study.

Dr. Maria Abreu from Cedars-Sinai Medical Center will present findings on this targeted oral peptide that selectively blocks IL-23 receptor activation in moderately to severely active ulcerative colitis. The presentation is scheduled for October 7, 2025, at 3:06 PM CET in the Helsinki Room during the Advanced Therapies in Ulcerative Colitis session.