Protagonist Therapeutics Announces Oral and Poster Presentations on Rusfertide at the 67th Annual ASH Meeting

Rhea-AI Summary

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.

Insights

Hematology Clinical Development Analyst

Phase 3 durability and safety data for rusfertide will be presented at ASH; this is a meaningful clinical milestone to monitor.

Protagonist will feature four presentations on rusfertide, including randomized Phase 3 VERIFY durability and safety results through week 52, patient-reported outcome analyses, dermatologic observations prior to drug exposure, and initial long-term data from a Phase 2 extension. These disclosures move clinical evidence into the public domain and let clinicians and guideline groups examine efficacy durability and tolerability over one year.

Key dependencies include the actual numeric results shown at the sessions and any safety signals disclosed; those facts will determine clinical adoption and regulatory relevance. Immediate items to watch are the oral presentation on December 6, 2025 for the VERIFY week 52 durability and safety endpoints and the patient-reported outcome poster on December 8, 2025, as both address efficacy persistence and quality-of-life impact within a one-year window.

NEWARK, CALIFORNIA / ACCESS Newswire / November 3, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced that clinical data on rusfertide in polycythemia vera, including the Phase 3 VERIFY study, will be the focus of four presentations at the 67^th Annual American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida, from December 6-9, 2025.

ASH Presentation Details:
Presenting Author: Andrew Kuykendall, MD (Moffitt Cancer Center)
Publication Number: 81
Title: Rusfertide or placebo plus current standard-of-care therapy for polycythemia vera: Durability of response and safety results through week 52 from the randomized controlled phase 3 VERIFY study
Oral Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Expanding the Therapeutic and Prognostic Landscape in Myeloproliferative Neoplasms, Mastocytosis and Hypereosinophilic Syndrome
Session Date: Saturday, December 6, 2025
Presentation Time: 10:00 AM - 10:15 AM EST
Location: Orlando Convention Center, W414CD

Presenting Author: Aniket Bankar, MD (Princess Margaret Cancer Centre)
Publication Number: 5588
Title: Comprehensive Analyses of Patient-Reported Outcomes from the Phase 3 VERIFY Study of Rusfertide or Placebo Plus Current Standard of Care for Polycythemia Vera
Poster Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 8, 2025
Presentation Time: 6:00 PM - 8:00 PM EST
Location: Orlando Convention Center, Poster Hall (West Halls B3-B4)

Presenting Author: Joseph Shatzel, MD (Oregon Health & Science University)
Publication Number: 5587
Title: Should Dermatologic Examinations Become Routine Standard of Care in Patients with Polycythemia Vera, Observations from the Phase 3 VERIFY Study Prior to Rusfertide Exposure
Poster Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 8, 2025
Presentation Time: 6:00 PM - 8:00 PM EST
Location: Orlando Convention Center, Poster Hall (West Halls B3-B4)

Presenting Author: Naveen Pemmajaru, MD (MD Anderson Cancer Center)
Publication Number: 3810
Title: Long-term Rusfertide Treatment in Polycythemia Vera: Initial Results from the Phase 2
THRIVE Extension Study
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 7, 2025
Presentation Time: 6:00 PM - 8:00 PM EST
Location: Orlando Convention Center, Poster Hall (West Halls B3-B4)

About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application (NDA) for icotrokinra submitted to the FDA in July and in the NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company, Inc. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin program.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.

Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061

SOURCE: Protagonist Therapeutics

View the original press release on ACCESS Newswire

FAQ

When will Protagonist Therapeutics (PTGX) present rusfertide data at ASH 2025?

Presentations are scheduled during the ASH meeting in Orlando, Dec 6–9, 2025, with specific sessions Dec 6–8, 2025.

Which rusfertide studies will PTGX (PTGX) report at ASH 2025?

Data come from the Phase 3 VERIFY randomized study (week 52 results and PROs) and the Phase 2 THRIVE extension initial results.

What VERIFY results will be presented for PTGX (PTGX) at ASH Dec 6, 2025?

An oral presentation on durability of response and safety through week 52 from the randomized Phase 3 VERIFY study.

Who are the presenting authors for PTGX rusfertide posters at ASH 2025?

Presenters include Andrew Kuykendall MD, Aniket Bankar MD, Joseph Shatzel MD, and Naveen Pemmajaru MD.

Where and when is the PTGX oral session at ASH 2025?

Oral session: Dec 6, 2025, 10:00–10:15 AM ET at Orlando Convention Center, room W414CD.

Will PTGX present patient-reported outcomes for rusfertide at ASH 2025?

Yes. A poster presentation will cover comprehensive analyses of patient-reported outcomes from the Phase 3 VERIFY study.