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News about Protagonist Therapeutics, Inc. (NASDAQ: PTGX) centers on its progress as a discovery-through-late-stage development biopharmaceutical company advancing peptide-based drug candidates. Company announcements frequently highlight clinical and regulatory milestones for its lead investigational therapies, icotrokinra and rusfertide, as well as updates from its broader pipeline and collaborations.
Investors following PTGX news will see regular coverage of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. Press releases describe data from Phase 3 ICONIC studies in moderate-to-severe plaque psoriasis, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2, as well as the Phase 2b ANTHEM-UC trial in ulcerative colitis. News items also report on regulatory submissions, such as the New Drug Application to the U.S. FDA and an application to the European Medicines Agency for plaque psoriasis.
Coverage of rusfertide focuses on its development for polycythemia vera in collaboration with Takeda. News releases describe Phase 3 VERIFY study results, long-term extension data from THRIVE, and the submission of a New Drug Application to the FDA for adults with polycythemia vera. These updates often include details on hematocrit control, phlebotomy requirements, patient-reported outcomes, and regulatory designations such as Breakthrough Therapy, Orphan Drug, and Fast Track status.
Additional PTGX news includes presentations at major medical and scientific conferences, such as the American Society of Hematology Annual Meeting, European Academy of Dermatology and Venereology Congress, American College of Gastroenterology meeting, and the J.P. Morgan Healthcare Conference. The company also issues periodic financial result and corporate update releases, which summarize recent clinical achievements, collaboration developments with Johnson & Johnson and Takeda, and progress in earlier-stage programs like PN-881, PN-477, and the oral hepcidin initiative.
For readers tracking PTGX, this news stream provides insight into Protagonist’s clinical data, regulatory interactions, partnership activities, and pipeline evolution as described in its own public communications.
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.
Summary not available.