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News about Protagonist Therapeutics, Inc. (NASDAQ: PTGX) centers on its progress as a discovery-through-late-stage development biopharmaceutical company advancing peptide-based drug candidates. Company announcements frequently highlight clinical and regulatory milestones for its lead investigational therapies, icotrokinra and rusfertide, as well as updates from its broader pipeline and collaborations.
Investors following PTGX news will see regular coverage of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. Press releases describe data from Phase 3 ICONIC studies in moderate-to-severe plaque psoriasis, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2, as well as the Phase 2b ANTHEM-UC trial in ulcerative colitis. News items also report on regulatory submissions, such as the New Drug Application to the U.S. FDA and an application to the European Medicines Agency for plaque psoriasis.
Coverage of rusfertide focuses on its development for polycythemia vera in collaboration with Takeda. News releases describe Phase 3 VERIFY study results, long-term extension data from THRIVE, and the submission of a New Drug Application to the FDA for adults with polycythemia vera. These updates often include details on hematocrit control, phlebotomy requirements, patient-reported outcomes, and regulatory designations such as Breakthrough Therapy, Orphan Drug, and Fast Track status.
Additional PTGX news includes presentations at major medical and scientific conferences, such as the American Society of Hematology Annual Meeting, European Academy of Dermatology and Venereology Congress, American College of Gastroenterology meeting, and the J.P. Morgan Healthcare Conference. The company also issues periodic financial result and corporate update releases, which summarize recent clinical achievements, collaboration developments with Johnson & Johnson and Takeda, and progress in earlier-stage programs like PN-881, PN-477, and the oral hepcidin initiative.
For readers tracking PTGX, this news stream provides insight into Protagonist’s clinical data, regulatory interactions, partnership activities, and pipeline evolution as described in its own public communications.
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.
Protagonist Therapeutics (NASDAQ:PTGX) reported significant financial and operational achievements for Q4 and full year 2024. The company earned a $165.0 million milestone for icotrokinra in Q4 2024 and nominated PN-881 as a development candidate for oral IL-17 receptor antagonist.
Key financial highlights include cash position of $559.2 million as of December 31, 2024, providing runway through 2028. The company reported total license and collaboration revenue of $434.4 million for 2024, a significant increase from $60.0 million in 2023. Net income reached $275.2 million ($4.23 per diluted share) for 2024, compared to a net loss of $(79.0) million in 2023.
Important upcoming milestones include topline results for rusfertide Phase 3 VERIFY trial in polycythemia vera and icotrokinra Phase 2b ANTHEM trial in ulcerative colitis, both expected in March 2025.
Protagonist Therapeutics has announced an upcoming investor event scheduled for February 6, 2025, in New York, offering both in-person and virtual attendance options. The event will feature expert insights from Dr. Andrew Kuykendall (Moffitt Cancer Center) and Dr. Joseph Michael Scandura (Weill Cornell Medicine) focusing on polycythemia vera (PV), a rare chronic blood disorder, and the potential of their drug candidate Rusfertide.
The presentation will cover comprehensive data from the Phase 2 PACIFIC and REVIVE trials, along with details about the Phase 3 VERIFY study design. Notably, the VERIFY study's topline results are expected in March 2025. Management will also discuss Rusfertide's commercial potential. The event will include a Q&A session and an informal lunch for in-person attendees.
Protagonist Therapeutics (Nasdaq:PTGX) announced the issuance of inducement awards to Newman Yeilding, M.D., who was appointed as Executive Vice President and Chief Scientific Officer. The awards, granted on January 2, 2025, include options to purchase 38,520 shares at an exercise price of $38.98 per share and 31,779 restricted stock units (RSUs).
The stock options vest over four years, with 25% vesting after the first year and the remainder vesting monthly over three years. The RSUs will vest annually over four years, with one-fourth vesting each year. Dr. Yeilding previously served as the Company's Chief Scientific Advisor from August 1, 2024, through January 1, 2025. The awards were granted under the company's Amended and Restated Inducement Plan and approved by the compensation committee.
Protagonist Therapeutics (PTGX) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 12-16, 2025, in San Francisco. Dinesh V. Patel, Ph.D., President and CEO, will deliver a company overview presentation on Tuesday, January 14, at 8:15 AM PT.
The presentation will be available via webcast, and the company will engage in one-on-one meetings during the conference. Interested parties can arrange meetings through their J.P. Morgan representatives. A replay of the presentation will be accessible on the Company's Investor Relations Events and Presentations webpage for one year after the event.
Protagonist Therapeutics announced final data from the rusfertide Phase 2 REVIVE study for polycythemia vera (PV) treatment at the ASH 2024 Annual Meeting. The study demonstrated significant results with 54% of patients achieving durable hematocrit control for over 2.5 years.
The trial included 70 patients in Part 1 (dose-finding), 59 in Part 2 (randomized withdrawal), and 58 in Part 3 (open-label extension). Key findings showed hematocrit control below 45%, reduced phlebotomy needs from >5/year to <1/year, and improved patient-reported outcomes. The treatment was well-tolerated, with most adverse events being mild to moderate.
The company expects VERIFY Phase 3 topline results in Q1 2025.
Protagonist Therapeutics announced its participation in the 7th Annual Evercore ISI HealthCONx Conference scheduled for December 3-5, 2024, in Coral Gables, Florida. Dinesh V. Patel, Ph.D., President and CEO, will engage in a fireside chat on Tuesday, December 3 at 8:45 A.M. ET. The presentation will be accessible via webcast, and the company will also conduct one-on-one meetings during the conference. A replay of the fireside chat will remain available on the company's Investor Relations Events and Presentations webpage for one year after the event.
Protagonist Therapeutics announced PN-881, a potential best-in-class oral peptide IL-17 antagonist, as a development candidate for immune-mediated skin diseases. The drug has shown superior potency compared to anti-IL-17 oral small molecules and comparable effectiveness to injectable antibody treatments. PN-881 demonstrated effective blockade of all three therapeutically relevant IL-17 dimers, with approximately 100-fold greater potency than secukinumab. The company plans to initiate Phase 1 clinical trials in Q4 2025, with potential expansion into psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthropathies based on psoriasis study results.
Protagonist Therapeutics has scheduled a conference call and webcast for November 21st at 4:30 pm ET to announce their new oral peptide IL-17 antagonist development candidate. During the presentation, the company will share in vitro and pre-clinical proof-of-concept study results.
US investors can dial 1-877-407-0752, while international investors can access the call at 1-201-389-0912 using Conference ID 13750274. The webcast will be available through a provided link, and a replay will be accessible on the Company's Investor Relations Events and Presentations webpage after the event.