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.
Protagonist Therapeutics (NASDAQ:PTGX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. JNJ-2113 Phase 3 trials in psoriasis and Phase 2b trial in ulcerative colitis expected to complete primary endpoint portions in Q4 2024.
2. Rusfertide Phase 3 VERIFY study topline results expected in Q1 2025.
3. Cash position of $595.4M as of June 30, 2024, providing runway through end of 2027.
4. Q2 2024 financial results: License and collaboration revenue of $4.2M, R&D expenses of $33.5M, G&A expenses of $9.4M, and net loss of $30.6M.
5. Six-month 2024 results show net income of $176.7M, primarily due to the $300M upfront payment from the Takeda collaboration agreement.
Protagonist Therapeutics announced the publication of preclinical and phase 1 clinical data on JNJ-2113 in Scientific Reports. JNJ-2113 is the first-in-class targeted oral peptide inhibitor of the IL-23 receptor in clinical development. The study demonstrated JNJ-2113's high potency, selectivity, and efficacy in various models. Key findings include:
1. Single-digit picomolar affinity binding to IL-23R
2. Efficacy in skin inflammation and colitis models
3. Dose-proportional pharmacokinetics in humans
4. Well-tolerated in healthy volunteers
JNJ-2113 is currently in Phase 3 trials for psoriasis and Phase 2b for ulcerative colitis, with results expected in 3-9 months.
Protagonist Therapeutics (NASDAQ:PTGX) has appointed Newman Yeilding, M.D. as Chief Scientific Advisor, effective August 1, 2024. Dr. Yeilding, an accomplished physician-scientist with expertise in inflammatory and immunologic diseases, joins from Janssen Pharmaceutical Companies of Johnson & Johnson. He brings 17 years of experience in R&D and commercialization of novel therapeutics in the I&I space.
As Chief Science Advisor, Dr. Yeilding will provide leadership in discovery, pre-clinical, and translational research to maximize the impact of Protagonist's peptide platform. His appointment aligns with the company's goal to expand its pipeline with drug candidates having blockbuster potential, including the oral peptide IL-17 antagonist program.
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.
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.
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.
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.
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.
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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