Protagonist Ther Stock Price, News & Analysis

Protagonist Therapeutics (PTGX) announced that its drug rusfertide received Breakthrough Therapy Designation from the FDA for treating erythrocytosis in polycythemia vera (PV) patients. This designation complements the drug's existing Orphan Drug and Fast Track designations, potentially expediting its development and review process.

The designation was supported by positive 32-week data from the Phase 3 VERIFY study, presented at the 2025 ASCO Annual Meeting. The company remains on track for a New Drug Application (NDA) submission in Q4 2025. Rusfertide demonstrated positive results across all primary and secondary endpoints, including hematocrit control and decreased phlebotomy dependence. The drug is being co-developed with Takeda Pharmaceuticals under a worldwide collaboration agreement from 2024.

[ "Received FDA Breakthrough Therapy Designation, adding to existing Orphan Drug and Fast Track designations", "Positive Phase 3 VERIFY trial results across all primary and secondary endpoints", "Strategic partnership with Takeda Pharmaceuticals for worldwide development", "On track for NDA submission in Q4 2025" ]

Protagonist Therapeutics (NASDAQ:PTGX) reported Q2 2025 financial results and significant pipeline progress. The company submitted an NDA for icotrokinra to treat psoriasis and plans to present Phase 2b ANTHEM trial data in ulcerative colitis at UEGW. Their Phase 3 VERIFY trial data for rusfertide in polycythemia vera was presented at ASCO, with NDA filing expected in Q4.

Financial highlights include $673.0 million in cash and equivalents (vs $559.2M in Dec 2024), providing runway through 2028. Q2 revenue was $5.5 million, with a net loss of $34.8 million ($0.55 per share). R&D expenses increased to $37.0 million, while G&A expenses rose to $10.6 million.

The company also advanced its pipeline with PN-477, a triple agonist anti-obesity peptide, and PN-881, an oral IL-17 peptide antagonist showing promising preclinical results.

Protagonist Therapeutics (NASDAQ:PTGX) has announced the submission of a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class oral peptide therapy for moderate to severe plaque psoriasis. The submission is supported by impressive data from four Phase 3 clinical trials that demonstrated significant efficacy and favorable safety in both adults and pediatric patients aged 12 and older.

The drug, developed in collaboration with Johnson & Johnson, showed superior results compared to deucravacitinib in the ICONIC-ADVANCE studies. Safety data revealed similar adverse event rates between icotrokinra (49.1%) and placebo (51.9%). The treatment offers a unique advantage as a once-daily pill that selectively blocks the IL-23 receptor, potentially transforming the treatment paradigm for plaque psoriasis.

The comprehensive clinical package includes successful results across multiple trials, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2, with additional studies ongoing for potential expansion into other indications such as psoriatic arthritis, ulcerative colitis, and Crohn's disease.

Protagonist Therapeutics (NASDAQ:PTGX) has announced the nomination of PN-477, a novel GLP-1, GIP, and GCG receptor triple agonist peptide, as a development candidate for obesity treatment. The drug candidate features both oral (PN-477o) and injectable (PN-477sc) formulations, designed for once-daily and once-weekly administration respectively.

The company reports that PN-477 has demonstrated potent in vitro activity in activating all three targeted receptors and has shown robust preclinical proof-of-concept in various animal studies, including diet-induced obesity mouse models, normal dogs, and cynomolgus monkeys. The candidate is engineered to be orally stable with balanced potencies against the three receptors to potentially maximize weight loss benefits while minimizing adverse effects.

Protagonist has initiated IND-enabling studies and expects to begin Phase 1 clinical trials in the second quarter of 2026. The company positions PN-477 as a potential best-in-class treatment option, aiming to offer weight loss comparable to the best injectable treatments while providing the flexibility of both oral and injectable administration routes.

Protagonist Therapeutics (NASDAQ:PTGX) has scheduled a conference call and webcast for Monday, June 30th at 4:30 pm ET to announce its oral obesity development candidate. The presentation will include details about in vitro and pre-clinical proof-of-concept study results.

Investors can access the call through US dial-in (1-877-407-0752) or international dial-in (1-201-389-0912) using Conference ID 13754335. A webcast replay will be available on the company's Investor Relations webpage after the event.

Protagonist and Takeda announced positive Phase 3 VERIFY study results for rusfertide in treating polycythemia vera (PV), to be presented at ASCO. The study met its primary endpoint with 76.9% of patients on rusfertide plus standard care achieving clinical response vs 32.9% in placebo group. Key findings include a reduction in required phlebotomies (0.5 vs 1.8 per patient) and improved hematocrit control (62.6% vs 14.4% maintaining levels below 45%). The drug showed significant improvements in patient-reported outcomes including fatigue and symptom burden. Rusfertide was well-tolerated with no serious drug-related adverse events, and has received FDA Orphan Drug and Fast Track designations. The treatment represents a potential first-in-class therapy for PV, a condition characterized by red blood cell overproduction that can lead to serious thrombotic events.

Protagonist Therapeutics (PTGX) has announced its participation in the upcoming Jefferies Global Healthcare Conference, scheduled for June 3-5, 2025, in New York. The company's President and CEO, Dinesh V. Patel, Ph.D., will deliver a company overview presentation on Wednesday, June 4, at 1:25 P.M. ET.

The presentation will be available via webcast, and the company will also engage in one-on-one meetings during the conference. Interested parties can access the presentation replay on the Company's Investor Relations Events and Presentations webpage for one year following the event.

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.