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Protagonist Therapeutics, Inc., a biopharmaceutical company, discovers and develops peptide-based therapeutic drugs to address hematology and blood disorders, and inflammatory and immunomodulatory diseases. It is developing rusfertide (PTG-300), an injectable hepcidin mimetic that is in Phase II clinical trials for the treatment of patients with polycythemia vera and hereditary hemochromatosis, as well as for the treatment of other blood disorders; PN-943, an oral, alpha-4-beta-7 integrin- specific antagonist peptide that is in Phase II clinical trials for treating inflammatory bowel disease (IBD); and PN-235, an orally delivered interleukin-23 receptor specific antagonist for the treatment of IBD and non-IBD indications. The company has a license and collaboration agreement with Janssen Biotech, Inc. Protagonist Therapeutics, Inc. was incorporated in 2006 and is headquartered in Newark, California.

Protagonist Therapeutics, Inc.

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OSAKA, JAPAN & CAMBRIDGE, MASS. & NEWARK, CALIF.--(BUSINESS WIRE)--TAKEDA (TSE:4502/NYSE:TAK) AND PROTAGONIST THERAPEUTICS, INC. (PROTAGONIST) (NASDAQ:PTGX) TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTED THE NEW DRUG APPLICATION (NDA) AND GRANTED PRIORITY REVIEW FOR RUSFERTIDE. RUSFERTIDE IS AN INVESTIGATIONAL, FIRST-IN-CLASS HEPCIDIN MIMETIC PEPTIDE THERAPEUTIC FOR THE TREATMENT OF ADULTS WITH POLYCYTHEMIA VERA (PV). THE FDA HAS SET A PRESCRIPTION DRUG USER FEE ACT.

TAKEDA AND PROTAGONIST ANNOUNCE U.S. FOOD AND DRUG ADMINISTRATION ACCEPTS NEW DRUG APPLICATION AND GRANTS PRIORITY REVIEW FOR RUSFERTIDE AS A POTENTIAL FIRST-IN-CLASS THERAPY FOR POLYCYTHEMIA VERA

(THIS RELEASE UPDATES THE RELEASE THAT POSTED EARLIER ON FEBRUARY 25, 2026 TO UPDATE THE SUB HEADLINES.) NDA FOR RUSFERTIDE SUBMITTED TO THE US FOOD AND DRUG ADMINISTRATION (FDA), WITH POTENTIAL APPROVAL AND LAUNCH THIS YEAR COMPANY EXPECTS TO OPT-OUT OF THE 50:50 PROFIT AND LOSS SHARING ARRANGEMENT FOR RUSFERTIDE WITH TAKEDA DURING A 90-DAY WINDOW EXPECTED TO OPEN IN Q2 U.S. REGULATORY DECISION FOR ICOTYDETM (ICOTROKINRA) ANTICIPATED IN 2026 WITH POTENTIAL LAUNCH THIS YEAR PN-881 PHASE 1 COMPLETION EXPECTED BY MID-2026 PRE-CLINICAL PIPELINE EXPANDED WITH NOVEL WHOLLY-OWNED CANDIDATES PN-477, AN ORAL AND S.C.

CORRECTION: PROTAGONIST REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

NDA FOR RUSFERTIDE SUBMITTED TO THE US FOOD AND DRUG ADMINISTRATION (FDA), WITH POTENTIAL APPROVAL AND LAUNCH THIS YEAR COMPANY EXPECTS TO OPT-OUT OF THE 50:50 PROFIT AND LOSS SHARING ARRANGEMENT FOR RUSFERTIDE WITH TAKEDA DURING A 90-DAY WINDOW EXPECTED TO OPEN IN Q2 U.S. REGULATORY DECISION FOR ICOTYDETM (ICOTROKINRA) ANTICIPATED IN 2026 WITH POTENTIAL LAUNCH THIS YEAR PN-881 PHASE 1 COMPLETION EXPECTED BY MID-2026 NEWARK, CALIFORNIA / ACCESS NEWSWIRE / FEBRUARY 25, 2026 / PROTAGONIST THERAPEUTICS (NASDAQ:PTGX) ("PROTAGONIST" OR "THE COMPANY") TODAY REPORTED FINANCIAL RESULTS FOR THE FOURTH QUARTER AND FULL YEAR ENDED DECEMBER 31, 2025 AND PROVIDED A CORPORATE UPDATE. "IN 2025, PROTAGONIST REACHED NEW HEIGHTS WITH MULTIPLE SUCCESSFUL PHASE 3 OUTCOMES AND TWO NDA FILINGS OF OUR PARTNERED ASSETS, ICOTYDE AND RUSFERTIDE," SAID DINESH V.

PROTAGONIST REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

NEWARK, CA / ACCESS NEWSWIRE / FEBRUARY 24, 2026 / PROTAGONIST THERAPEUTICS, INC. ("PROTAGONIST" OR THE "COMPANY") TODAY ANNOUNCED THAT DINESH V. PATEL, PH.D.

PROTAGONIST THERAPEUTICS TO PARTICIPATE IN MULTIPLE INVESTMENT BANK CONFERENCES IN MARCH 2026

NEWARK, CA / ACCESS NEWSWIRE / JANUARY 7, 2026 / PROTAGONIST THERAPEUTICS, INC. ("PROTAGONIST" OR THE "COMPANY") TODAY ANNOUNCED THAT DINESH V. PATEL, PH.D.

PROTAGONIST THERAPEUTICS TO PARTICIPATE IN THE 44TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE 2026

OSAKA, JAPAN & CAMBRIDGE, MASS. & NEWARK, CALIF.--(BUSINESS WIRE)--TAKEDA (TSE:4502/NYSE:TAK) AND PROTAGONIST THERAPEUTICS (NASDAQ: PTGX) (PROTAGONIST) ANNOUNCED THE SUBMISSION OF A NEW DRUG APPLICATION (NDA) TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) SEEKING APPROVAL OF RUSFERTIDE FOR THE TREATMENT OF ADULTS WITH POLYCYTHEMIA VERA (PV). RUSFERTIDE IS AN INVESTIGATIONAL FIRST-IN-CLASS SUBCUTANEOUSLY ADMINISTERED HEPCIDIN MIMETIC PEPTIDE DESIGNED TO REGULATE IRON HOMEOSTASIS AND RED BLOOD.

TAKEDA AND PROTAGONIST ANNOUNCE SUBMISSION OF NEW DRUG APPLICATION (NDA) FOR RUSFERTIDE FOR TREATMENT OF POLYCYTHEMIA VERA (PV)

NEWARK, CALIF. & OSAKA, JAPAN & CAMBRIDGE, MASS.--(BUSINESS WIRE)--PROTAGONIST THERAPEUTICS, INC. (PROTAGONIST) (NASDAQ:PTGX) AND TAKEDA (TSE:4502/NYSE:TAK) ANNOUNCE THAT NEW 52-WEEK RESULTS FROM THE PIVOTAL PHASE 3 VERIFY STUDY EVALUATING RUSFERTIDE IN PATIENTS WITH POLYCYTHEMIA VERA (PV) WILL BE PRESENTED IN AN ORAL PRESENTATION AT THE 67TH AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING AND EXPOSITION. THESE FINDINGS FURTHER REINFORCE RUSFERTIDE'S EFFICACY AND SAFETY AND DEMONSTRATE DU.

PROTAGONIST AND TAKEDA PRESENT LONGER-TERM DATA AT ASH 2025 SHOWING RUSFERTIDE DELIVERS DURABLE RESPONSE AND HEMATOCRIT CONTROL IN POLYCYTHEMIA VERA

FOLLOWING THE NDA SUBMISSION FOR ICOTROKINRA TREATMENT OF ADULTS AND ADOLESCENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS TO THE U.S. FDA IN JULY, THE EUROPEAN MEDICINES AGENCY (EMA) APPLICATION WAS SUBMITTED IN SEPTEMBER RUSFERTIDE GRANTED BREAKTHROUGH DESIGNATION FOR PATIENTS IN POLYCYTHEMIA VERA (PV) AND THE SUBJECT OF FOUR PRESENTATIONS INCLUDING 52-WEEK RESULTS OF THE VERIFY PHASE 3 STUDY AT ASH, THE 67TH ANNUAL AMERICAN SOCIETY OF HEMATOLOGY (ASH) MEETING IN DECEMBER FIRST PATIENT DOSED IN THE PHASE 1 TRIAL OF PN-881, A FIRST-IN-CLASS ORAL IL-17 PEPTIDE ANTAGONIST IND-ENABLING STUDIES PROGRESSING AS PLANNED WITH TRIPLE-GLP/GIP/GCG AGONISTS PN-477SC AND PN-477O ORAL HEPCIDIN DEVELOPMENT CANDIDATE EXPECTED TO BE NOMINATED BY YEAR END CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES OF $678.8 MILLION AS OF SEPTEMBER 30, 2025, ANTICIPATED TO PROVIDE CASH RUNWAY THROUGH AT LEAST END OF 2028 NEWARK, CA / ACCESS NEWSWIRE / NOVEMBER 6, 2025 / PROTAGONIST THERAPEUTICS (NASDAQ:PTGX) ("PROTAGONIST" OR "THE COMPANY") TODAY REPORTED FINANCIAL RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2025, AND PROVIDED A CORPORATE UPDATE. "2025 CONTINUES TO BE A HIGHLY PRODUCTIVE YEAR WITH SIGNIFICANT ACCOMPLISHMENTS IN BOTH PARTNERED AND WHOLLY OWNED PROGRAMS," SAID DINESH V.

PROTAGONIST REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

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 67TH 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.

PROTAGONIST THERAPEUTICS ANNOUNCES ORAL AND POSTER PRESENTATIONS ON RUSFERTIDE AT THE 67TH ANNUAL ASH MEETING

NEWARK, CALIFORNIA / ACCESS NEWSWIRE / AUGUST 26, 2025 / PROTAGONIST THERAPEUTICS, INC. ("PROTAGONIST" OR THE "COMPANY") TODAY ANNOUNCED THAT DINESH V. PATEL, PH.D.

Protagonist Therapeutics, Inc.

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