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Protagonist Therapeutics, Inc. - PTGX STOCK NEWS

Welcome to our dedicated page for Protagonist Therapeutics news (Ticker: PTGX), a resource for investors and traders seeking the latest updates and insights on Protagonist Therapeutics stock.

Protagonist Therapeutics, Inc. (NASDAQ: PTGX) is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to discover and develop novel peptide-based drugs. The company's primary focus is on creating first-in-class oral targeted therapies that inhibit biological pathways currently addressed by injectable antibody drugs. This innovative approach aims to treat significant unmet medical needs, particularly in the areas of inflammatory bowel disease (IBD) and other autoimmune diseases.

Protagonist's lead peptide product candidates, PTG-100 and PTG-200, are designed to transform treatment paradigms for conditions such as ulcerative colitis and Crohn's disease. PTG-100, an oral peptide alpha-4-beta-7 integrin antagonist, is in a global Phase 2b clinical trial for moderate-to-severe ulcerative colitis. PTG-200, a first-in-class oral interleukin-23 receptor antagonist, is also progressing through clinical trials.

Another key asset, JNJ-2113 (formerly PN-235), achieved primary and secondary endpoints in the Phase 2b FRONTIER 1 trial for moderate-to-severe plaque psoriasis. This drug is part of an extensive clinical development program, including multiple Phase 3 studies under the ICONIC program. JNJ-2113 is also being evaluated in a Phase 2b ANTHEM-UC study for ulcerative colitis.

Protagonist's pipeline also includes Rusfertide (PTG-300), an injectable hepcidin mimetic currently in Phase 3 development for polycythemia vera. The REVIVE Phase 2 study demonstrated that rusfertide effectively maintains hematocrit control and reduces the need for phlebotomies in patients.

The company has established significant partnerships to further its clinical programs. Notably, Protagonist collaborates with Johnson & Johnson and Takeda Pharmaceuticals to co-develop and co-commercialize its lead candidates, expanding its reach and impact in the biopharmaceutical landscape.

Protagonist continues to drive innovation with its ongoing discovery efforts, aiming to develop additional oral peptides targeting validated biological pathways. With a robust pipeline and strategic collaborations, Protagonist Therapeutics is poised to make substantial contributions to the treatment of autoimmune and hematological diseases.

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Protagonist Therapeutics (NASDAQ:PTGX) has announced its participation in the BTIG Virtual Biotechnology Conference 2024. The event is scheduled for August 5-6, 2024. Dinesh V. Patel, Ph.D., the company's President and CEO, will take part in a fireside chat on Tuesday, August 6 from 2:00-2:35 P.M. EDT.

In addition to the fireside chat, Protagonist's team will be available for one-on-one meetings during the conference. Interested parties are encouraged to contact their BTIG representative to arrange meetings with the Protagonist team.

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Protagonist Therapeutics presented updated long-term follow-up results from the Phase 2 REVIVE study of rusfertide at the EHA2024 Congress. The study shows that rusfertide provides durable control of hematocrit levels below 45% for up to 3 years in patients with polycythemia vera. Additionally, it reduced the need for phlebotomies and normalized serum ferritin levels without new safety concerns. As of April 9, 2024, 81% of patients remain on treatment, with many transitioning to the THRIVE study for an additional two years. The study reports a stable safety profile, despite a small increase in localized, early-stage skin cancer cases among high-risk patients.

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Protagonist Therapeutics announced its participation at the Jefferies Global Healthcare Conference 2024, scheduled for June 4-6 in New York City.

Dinesh V. Patel, Ph.D., President and CEO, will engage in a fireside chat on June 5 at 11:00-11:25 A.M. EDT and hold one-on-one meetings with participants.

The fireside chat will be webcasted live and a replay will be available for 90 days on the company's website.

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Protagonist Therapeutics (NASDAQ:PTGX) announced that new data from its rusfertide Phase 2 REVIVE study will be presented at the European Hematology Association (EHA) Congress scheduled for June 13-16, 2024, in Madrid, Spain. The presentation will focus on long-term results, specifically hematocrit control and therapeutic phlebotomy frequency in patients with Polycythemia Vera. Additionally, an abstract published at the event will highlight the absence of QTc prolongation in a thorough QT/QTc study with healthy subjects. Key figures involved in the presentations include Dr. Kristen M. Pettit from the University of Michigan and Nishit Modi, SVP of Clinical Pharmacology at Protagonist.

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Protagonist Therapeutics, Inc. announced that their President and CEO, Dinesh V. Patel, Ph.D., will participate in the Citizens JMP Life Sciences Conference and the Capital One 1st Annual Biotech/Biopharma Disruptors Event in New York City on May 13-14, 2024.

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Protagonist Therapeutics reported strong financial results for Q1 2024 and significant corporate developments, including a partnership with Takeda for rusfertide, completion of Phase 3 trials for JNJ-2113, and upcoming milestones for the oral IL-17 program. The company's cash reserves remain healthy, with license and collaboration revenue of $255 million.

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Protagonist Therapeutics, Inc. is progressing well with the Phase 3 VERIFY clinical trial evaluating rusfertide in polycythemia vera. The Company has randomized 241 patients and aims to reach the 250 patient enrollment target by March 2024. Top-line data for the 32-week primary endpoint is expected in the first quarter of 2025. Rusfertide shows promise in addressing unmet medical needs for PV patients.
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Protagonist Therapeutics, Inc. announces the closing of a collaboration and license agreement with Takeda for rusfertide, with a $300 million upfront payment expected in Q2 2024.
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Protagonist Therapeutics, Inc. announced positive results from the Phase 2b FRONTIER 2 study evaluating JNJ-2113 for adult patients with moderate-to-severe plaque psoriasis. The study demonstrated sustained efficacy and similar safety results from Week 16 to Week 52, with high rates of skin clearance. The proportion of patients achieving PASI 75, 90, and 100 response rates at Week 16 were maintained through Week 52, confirming the durability of response. No evidence of dose-dependent increase in adverse events was observed across the treatment groups.
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Protagonist Therapeutics, Inc. announces participation in three upcoming investor conferences in March 2024, including the 2024 Jefferies Biotech on the Bay Summit, 13th Annual Napa Valley Biotech Forum, and H.C. Wainwright 2nd Annual Autoimmune and Inflammatory Disease Virtual Conference.
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FAQ

What is Protagonist Therapeutics' main focus?

Protagonist Therapeutics focuses on developing novel peptide-based drugs to address significant unmet medical needs, particularly for inflammatory bowel disease and autoimmune diseases.

What are PTG-100 and PTG-200?

PTG-100 is an oral peptide alpha-4-beta-7 integrin antagonist currently in Phase 2b trials for ulcerative colitis. PTG-200 is a first-in-class oral interleukin-23 receptor antagonist being developed for Crohn's disease.

What is JNJ-2113?

JNJ-2113 (formerly PN-235) is a targeted oral peptide designed to block the IL-23 receptor, currently being evaluated in multiple Phase 3 studies for moderate-to-severe plaque psoriasis and a Phase 2b study for ulcerative colitis.

What is rusfertide (PTG-300)?

Rusfertide is an injectable hepcidin mimetic in Phase 3 development for polycythemia vera. It has shown effectiveness in controlling hematocrit levels and reducing the need for phlebotomies.

Who are Protagonist's collaboration partners?

Protagonist collaborates with Johnson & Johnson and Takeda Pharmaceuticals to co-develop and co-commercialize its lead drug candidates.

What recent achievements has Protagonist announced?

Protagonist reported that JNJ-2113 met all primary and secondary endpoints in the Phase 2b FRONTIER 1 trial and is now in multiple Phase 3 studies. They also entered a significant partnership with Takeda Pharmaceuticals.

What is Protagonist's proprietary technology platform?

Protagonist's proprietary technology platform enables the discovery and development of novel constrained peptide-based drug candidates.

What are the latest developments in Protagonist's clinical trials?

Protagonist has ongoing Phase 3 trials for JNJ-2113 in psoriasis and a Phase 2b trial in ulcerative colitis, as well as a Phase 3 trial for rusfertide in polycythemia vera.

What is the status of the rusfertide Phase 3 VERIFY trial?

The Phase 3 VERIFY trial is nearing completion of enrollment, with top-line data expected by the first quarter of 2025.

Where can I find more information about Protagonist's drug candidates and clinical studies?

More information about Protagonist Therapeutics, its pipeline drug candidates, and clinical studies can be found on the company's website at www.protagonist-inc.com.

Protagonist Therapeutics, Inc.

Nasdaq:PTGX

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