NEWARK, CA / ACCESS Newswire / January 7, 2026 / Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026 in San Francisco, CA. The Company will also participate in one-on-one meetings.
44th Annual J.P. Morgan Healthcare Conference – January 12-15, 2026
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 a New Drug Application (NDA) for icotrokinra submitted to the FDA in July, and an NDA for rusfertide submitted in December 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. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the 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.
NEW YORK, NY / ACCESS Newswire / November 27, 2025 / Protagenic Therapeutics, Inc. (Nasdaq:PTIX) (the “Company”) today announced that it has received a notification letter from the Nasdaq Listing Qualifications Staff (the “Staff”) indicating that the Company is not in compliance with Nasdaq Listing Rules 5550(b)(1) (minimum stockholders’ equity) and 5250(c)(1) (timely filing of periodic reports).
The Staff determined that, based on the stockholders’ equity reported in the Company’s Transition Report on Form 10-QT for the period ended June 30, 2025, the Company no longer satisfies the minimum $2.5 million stockholders’ equity requirement under Listing Rule 5550(b)(1). The Staff also notified the Company that the delayed filing of its Form 10-Q for the quarter ended September 30, 2025 constitutes a separate basis for non-compliance under Listing Rule 5250(c)(1). The Company is completing the remaining steps needed to finalize the Form 10-Q and expects to file it imminently.
Under Nasdaq Listing Rule 5815, because the Company recently regained compliance and remains subject to a mandatory panel monitoring period, the Staff has issued a determination to delist the Company’s securities.
The Company will timely request a hearing before a Nasdaq Hearings Panel (the “Panel”).
●
Filing the hearing request automatically stays any suspension for 15 calendar days.
●
The Company will also request a stay of suspension pending the Panel’s decision.
●
During the automatic stay – and, if granted, the extended stay – the Company’s stock will continue to trade on The Nasdaq Capital Market.
There can be no assurance that the Panel will grant an extended stay or additional time for compliance. The Company intends to present its plan to address both deficiencies at the hearing.
About Protagenic Therapeutics, Inc.
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is a clinical-stage biopharmaceutical company developing therapeutics for neurological and neuropsychiatric conditions. More information is available at www.protagenic.com.
Forward-Looking Statements
Statements in this press release contain “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this current report include, without limitation, statements regarding the Company’s expected filing of its Quarterly Report on Form 10-Q, the Company’s planned appeal before the Panel, and the continued listing of the Company’s securities pending the appeal. Forward-looking statements are statements that are not historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks and uncertainties, and actual results may differ materially from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, without limitation, that there can be no assurance that the Company will file the Form 10-Q, that there can be no assurance that the Company will otherwise meet Nasdaq compliance standards, that there can be no assurance that Nasdaq will grant the Company any relief from delisting as necessary or whether the Company can agree to or ultimately meet applicable Nasdaq requirements for any such relief, and the other important factors described under the caption “Risk Factors” in the Company’s filings with the SEC. Any forward-looking statement made by the Company in this current report is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, the Company expressly disclaims any obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Company Contact:
Alexander K. Arrow, MD, CFA Chief Financial Officer Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010 Tel: 213-260-4342 Email: alex.arrow@protagenic.com
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. Patel, Ph.D., the Company’s President and CEO. “In addition to the NDA and EMA submissions for icotrokinra for psoriasis, we are pleased to see our partner Johnson and Johnson expand the ICONIC program into additional IL-23 pathway relevant and validated I&I indications, namely psoriatic arthritis, ulcerative colitis, and Crohn’s disease. We, along with our partner Takeda, eagerly await the presentation of the rusfertide 52-week VERIFY data at ASH in December and the NDA filing for rusfertide by year end.”
“As icotrokinra and rusfertide move towards potential NDA approval and commercialization in 2026, we shift our attention to the next phase of assets emerging from our validated discovery and development platform. We are pleased to report that the first subject in the Phase 1 trial of oral IL-17 antagonist, PN-881, is dosed. Additionally, the oral and subcutaneous triple GLP/GIP/GCG agonists, PN-477o and PN-477sc, are progressing through
IND-enabling studies as planned, and we remain on track to nominate a development candidate from the oral hepcidin program by year end. I am very proud of the consistent innovation and execution capabilities of the Protagonist team,” Patel said.
Third Quarter 2025 Recent Developments and Upcoming Milestones
Icotrokinra: Oral IL-23 Receptor Antagonist
In November, publications of ICONIC-LEAD data through Week 24 (available here) and ICONIC-TOTAL data through Week 16 (available here) were published in the New England Journal of Medicine, and the NEJM Evidence, respectively.
On October 27th, the Company and Johnson and Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC) at the 2025 ACG Annual Scientific Meeting. I cotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo.
On October 26 th , new long-term 52-week data from the Phase 3 ICONIC-TOTAL study, was presented at the 2025 Fall Clinical Dermatology Conference. The data show icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting these high-impact and difficult-to-treat areas of the body.
On October 7th, the Company and its partner JNJ announced Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active UC at United European Gastroenterology Week (UEGW) 2025.
On September 17th, new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies, which assessed the superiority of icotrokinra compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis (PsO), was presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Additionally, new long-term 52-week data from the Phase 3 ICONIC-LEAD study investigating icotrokinra in adults and pediatric patients 12 years of age and older (adolescents) with moderate to severe PsO was presented as a late-breaking abstract at EADV.
On September 11th, the Company announced the submission of an application to the European Medicines Agency (EMA) by JNJ seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe PsO.
On July 21st, the Company announced submission of a New Drug Application (NDA) to the U.S. FDA by JNJ seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe PsO.
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
Clinical data on rusfertide in PV, including the Phase 3 VERIFY study, are the focus of four presentations planned at the 67 th Annual American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida from December 6-9, 2025. This includes an oral presentation of the durability of response and safety results through week 52 from the VERIFY study.
On August 25th, the Company and its partner Takeda Pharmaceuticals announced rusfertide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with PV.
Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, is expected in Q4 of this year.
Discovery and Development Pipeline
The first human subject has been dosed in the Phase 1 trial ( NCT07153146 ) of PN-881, a first-in-class oral IL-17 peptide antagonist, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants.
The triple GLP/GIP/GCG agonists PN-477sc and PN-477o are progressing through IND-enabling studies with clinical study initiation of PN-477sc anticipated by mid-2026, and initiation of PN-477o anticipated in the second half of 2026.
The Company plans to nominate a development candidate ready for IND-enabling studies from the oral hepcidin program by year end.
Third Quarter 2025 Financial Results
Cash, Cash Equivalents and Marketable Securities : Cash, cash equivalents and marketable securities as of September 30, 2025, were $678.8 million as compared to $559.2 million as of December 31, 2024.
Three Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except per share amounts)
2025
2024
2025
2024
(Unaudited)
License and collaboration revenue
$
4,712
$
4,675
$
38,579
$
263,795
Research and development expense
$
40,003
$
35,970
$
112,932
$
103,224
General and administrative expense
$
11,130
$
10,158
$
33,419
$
34,508
Net (loss) income
$
(39,339
)
$
(33,210
)
$
(85,765
)
$
143,514
Basic earnings (loss) per share
$
(0.62)
$
(0.54)
$
(1.35)
$
2.34
Diluted earnings (loss) per share
$
(0.62)
$
(0.54)
$
(1.35)
$
2.22
License and Collaboration Revenue :
License and collaboration revenue was $4.7 million for both the three months ended 2025 and 2024 and was comprised of development services we provided under the Takeda collaboration agreement.
License and collaboration revenue of $38.6 million for the nine months ended September 30, 2025 was comprised of (i) proportional recognition of a $25 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period. License and collaboration revenue of $263.8 million for the nine months ended September 30, 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda collaboration agreement allocated to the rusfertide license upon effectiveness of the agreement, and (ii) development services we provided during the period.
Research and Development (“R&D”) Expenses : Increased by $4.0 million and $9.7 million for the three and nine months ended September 30, 2025, respectively, from the prior year periods. The increases were primarily due to increases in drug discovery and pre-clinical research expenses.
General and Administrative (“G&A”) Expenses : Increased by $1.0 million for the three months ended September 30, 2025, from the prior year period primarily due to increases in professional services. The decrease of $1.1 million in G&A expenses for the nine months ended September 30, 2025, from the prior year period was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda collaboration in Q1 24, partially offset by increases in personnel-related expenses and professional services.
Net Income (Loss) : Net loss was ($39.3) million, or ($0.62) per basic and diluted share, for the three months ended September 30, 2025, as compared to a net loss of ($33.2) million, or ($0.54) per basic and diluted share, for the three months ended September 30, 2024. Net loss was ($85.8) million, or ($1.35) per basic and diluted share, for the nine months ended September 30, 2025, as compared to net income of $143.5 million, or $2.34 per basic share and $2.22 per diluted share, for the nine months ended September 30, 2024.
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 a New Drug Application (NDA) for icotrokinra submitted to the FDA in July, and 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. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the 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 .
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra and PN-881, and expectations regarding the icotrokinra and PN-881 development programs. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
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. 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/.
Icotrokinra demonstrated clinically meaningful outcomes at Week 28 in the Phase 2b ANTHEM-UC study in ulcerative colitis, with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo
Updated ANTHEM-UC data support Phase 3 clinical development of icotrokinra in both moderately to severely active ulcerative colitis and Crohn’s disease
In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific clear or almost clear skin at Week 52 in Phase 3 ICONIC-TOTAL study
Further, 67% of patients treated with icotrokinra in the ICONIC-TOTAL study achieved overall rates of clear or almost clear skin by Week 24, which was maintained through Week 52
NEWARK, CALIFORNIA / ACCESS Newswire / October 27, 2025 / Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) today announced new data from two studies of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, presented at two recent medical conferences.
Week 28 data from the Phase 2b ANTHEM-UC study of icotrokinra will be presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG), demonstrating sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical response a , clinical remission b , endoscopic improvement c and histologic-endoscopic mucosal improvement (HEMI) d at Week 28 compared to placebo. [1] These outcomes build on Week 12 data that was recently presented at United European Gastroenterology (UEG) Week 2025.
Icotrokinra 400 mg once daily
Week 12
Week 28
Placebo (at Week 28)
Clinical response 1
63.5%
66.7%
25.4%
Clinical remission 1
30.2%
31.7%
9.5%
Endoscopic improvement 1
36.5%
38.1%
11.1%
HEMI rates 1
28.6%
33.1%
11.1%
Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC, as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn’s disease.
Additionally, new long-term 52-week data from the Phase 3 ICONIC-TOTAL study e , presented last week at the 2025 Fall Clinical Dermatology Conference, show icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting these high-impact and difficult-to-treat areas of the body. [2]
72% of patients with scalp psoriasis achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) 0/1 score and 57% achieved ss-IGA 0 f
85% of patients with genital psoriasis achieved a Physician’s Global Assessment of Genitalia (sPGA-G) 0/1 and 73% achieved sPGA-G 0 g
In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16, which increased through Week 52 with patients achieving a hand and/or foot Physician’s Global Assessment (hf-PGA) h score of 0/1 increasing from 42% to 62%.
Overall response rates among patients treated with once-daily icotrokinra were maintained through Week 52, with 67% of patients treated with icotrokinra achieving clear or almost clear skin (Investigator’s Global Assessment (IGA) i 0/1) and 44% achieving completely clear skin (IGA 0) at Week 52. The overall response rates were also comparable among patients who received icotrokinra for all 52 weeks and those who transitioned from placebo to icotrokinra at Week 16 (67% versus 68% achieved IGA0/1, respectively). Across treatment groups, adverse event and serious adverse event rates were similar through Week 52 compared to those through Week 16, with no new safety signals identified.
“Additional data from Phase 2b ANTHEM-UC and Phase 3 ICONIC-TOTAL studies continue to show a strong durability of response and clinical benefit of icotrokinra treatment in a range of inflammatory and immunological diseases,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. “We are very pleased to see that the ICONIC development program now includes both ICONIC-UC, a Phase 3 study in adults with moderately to severely active UC, and ICONIC-CD, a Phase 2b/3 study in adults with moderate to severely active Crohn’s disease. Our goal continues to be delivering well-differentiated oral targeted therapy treatments for patients as we continue to advance our oral peptides-based scientific and innovation leadership in the I&I field.”
Editor’s notes:
Clinical response was defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Clinical remission was defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Endoscopic improvement was defined as an endoscopy subscore of 0 or 1.
Histologic-endoscopic mucosal improvement (HEMI) was defined as histologic remission (absence of neutrophils from the mucosa in both lamina propria and epithelium, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1).
ICONIC-TOTAL evaluates the efficacy and safety of icotrokinra compared with placebo in participants with at least moderate scalp, genital, and/or hand/foot PsO with once-daily icotrokinra or placebo, with placebo-to-icotrokinra transition at Week 16.
The ss-IGA is a five-point scale where scalp lesions are assessed in terms of clinical signs of redness, thickness, and scaliness on a severity score ranging from 0 to 4, where 0 indicates absence of disease, 1 is very mild, 2 is mild, 3 is moderate and 4 indicates severe disease.
The sPGA-G is a six-point scale used to evaluate the severity of genital psoriasis at a given time point ranging from 0 to 5, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, 4 is severe and 5 indicates very severe disease. [3]
The Physician’s Global Assessment of Psoriasis on the Hands and/or Feet (hf-PGA) assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3) and severe (4). [4]
The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease. [5]
About ANTHEM-UC
ANTHEM-UC ( NCT06049017 ) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response.Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.
About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company.
ICONIC-LEAD ( NCT06095115 ) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.
ICONIC-TOTAL ( NCT06095102 ) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.
Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 ( NCT06143878 ) and ICONIC-ADVANCE 2 ( NCT06220604 ), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO. ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 ( NCT06878404 ) and ICONIC-PsA 2 ( NCT06807424 ) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.
Johnson & Johnson has also initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn’s disease.
About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales.Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.Living with plaque PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.
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 precisely blocks the Interleukin-23 receptor (“IL-23R”) which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the 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/ .
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra, and expectations regarding the icotrokinra development program. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Johnson & Johnson and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
[1] Jairath V., et al. Efficacy and Safety of Icotrokinra, a Targeted Oral Peptide That Selectively Blocks IL-23 Receptor Activation, In Ulcerative Colitis: Results From Week 28 of ANTHEM-UC, a Phase 2b Dose-ranging Trial. Poster 1066 at ACG Annual Scientific Meeting 2025. October 2025.
[2] Lain, E et al. Durability of Response to the Targeted Oral Peptide Icotrokinra for High-Impact Site Psoriasis: 1-Year ICONIC-TOTAL Findings. Oral presentation (Presentation FC01.1G) at the 2025 Fall Clinical Dermatology Conference. October 2025.
[3] Merola JF, Bleakman AP, Gottlieb AB, et al. The Static Physician’s Global Assessment of Genitalia: a clinical outcome measure for the severity of genital psoriasis. J Drugs Dermatol . 2017;16(8):793-799
[4] Goldblum O, et al. Validation of the physician’s global assessment of psoriasis of the hands and/or feet as a clinical endpoint. J Am Acad Dermatol. 2013:68(4)Supplement1:AB218.
[5] Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.04.104. Accessed April 2025.
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated achieving endoscopic improvement and 30.2% achieving clinical remission at the highest dose at Week 12 in the Phase 2b ANTHEM-UC study
These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis
Registrational Phase 3 study in ulcerative colitis and Phase 2b/3 study in Crohn’s disease anticipated to begin patient enrollment in Q4 2025
NEWARK, CALIFORNIA / ACCESS Newswire / October 7, 2025 / Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) today announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint, with all once-daily icotrokinra dose groups achieving clinical responsea at Week 12 and showing clinically meaningful improvements versus placebo across key secondary endpoints.1 These results underscore the potential of icotrokinra to deliver a valuable combination of significant therapeutic benefit and a favorable safety profile with once-daily oral dosing and are featured at United European Gastroenterology (UEG) Week 2025.
At Week 12, patients treated with 400 mg of icotrokinra once daily achieved a clinical response rate of 63.5% versus 27% for placebo (p1
Across multiple secondary endpoints, in the 400 mg icotrokinra group, significantly greater proportions of patients achieved clinical remission, symptomatic remission, and endoscopic improvement at Week 12 compared to placebo. Both the 200 mg and 100 mg once-daily dosing groups also showed meaningful improvements in these secondary endpoints relative to placebo. All icotrokinra doses demonstrated higher rates of symptomatic remission compared to placebo as early as Week 4.1
Similar proportions of participants reported adverse events and serious adverse events through Week 12 across all icotrokinra dose groups and the placebo group.1
Based on results from the Phase 2b ANTHEM-UC study, a Phase 3 trial in ulcerative colitis will be initiated. Icotrokinra is also being studied in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in July 2025 seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.
“The vast body of compelling data from Phase 2b and Phase 3 studies, including the most recent results from this Phase 2b study in ulcerative colitis, supports the thesis of IL-23R targeted oral peptide icotrokinra as a potential treatment option in a range of inflammatory and immunological diseases,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. “We are pleased to see the recent initiation of the registrational Phase 3 study of icotrokinra in UC and a Phase 2b/3 study in Crohn’s disease by our partner, along with the ongoing Phase 3 studies in psoriatic arthritis and the Phase 3 head-to-head results vs. ustekinumab in plaque psoriasis. We are also excited about the initiation of the Phase 1 study of our fully-owned oral IL-17 targeted oral peptide PN-881. Our goal is to deliver well-differentiated oral treatments for patients as we continue to advance our scientific and innovation leadership in the I&I field.”
Editor’s notes:
Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0 or 1.
Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Endoscopic improvement was defined as an endoscopy subscore of 0 or 1.
About ANTHEM-UC
ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally.2
About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.3
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. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the 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/.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra and PN-881, and expectations regarding the icotrokinra and PN-881 development programs. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
1Abreu M., et al. Icotrokinra, a targeted oral peptide that selectively blocks IL-23 receptor activation, in moderately to severely active ulcerative colitis: week 12 results from the phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging ANTHEMUC trial. Oral presentation OP206 at United European Gastroenterology Week (UEGW) 2025. October 2025.
