Welcome to our dedicated page for Protagonist Ther news (Ticker: PTGX), a resource for investors and traders seeking the latest updates and insights on Protagonist Ther stock.
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 (PTGX) announced promising results from a Phase 2a study for rusfertide, aimed at treating hereditary hemochromatosis (HH), a genetic disorder causing excessive iron absorption. The study involved 16 patients and demonstrated significant reductions in therapeutic phlebotomy requirements and improved serum iron levels. Rusfertide exhibited a favorable safety profile, with most adverse events being mild. This marks a critical step towards developing the first-in-class therapy for HH, addressing unmet medical needs for patients unable to undergo traditional phlebotomy.
Protagonist Therapeutics (Nasdaq: PTGX) announced that CEO Dinesh V. Patel, Ph.D., will present and engage in one-on-one investor meetings at the Jefferies London Healthcare Conference on November 18, 2021, and the Piper Sandler 33rd Annual Healthcare Conference on November 22, 2021. The Jefferies event is scheduled for 3 a.m. EST, while the Piper Sandler event will begin at 10 a.m. EST. A webcast will be available for 90 days on Protagonist's website. The company focuses on peptide-based therapies, including treatments for conditions like polycythemia vera and ulcerative colitis.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) has announced that two abstracts detailing updated data from its Phase 2 study of rusfertide in polycythemia vera (PV) will be presented orally at the ASH 2021 Annual Meeting from December 11-14. The presentations, scheduled for December 12, will showcase rusfertide's effectiveness in controlling hematocrit levels and reducing the need for phlebotomy. Additionally, three other abstracts will be presented as posters. Protagonist aims to advance rusfertide into a Phase 3 trial in early 2022.
Protagonist Therapeutics (PTGX) announced its Q3 2021 financial results, revealing a net loss of $33.8 million, or $0.70 per share, compared to a loss of $7.8 million in Q3 2020. The FDA lifted a clinical hold on rusfertide, allowing resumed studies. Notably, Protagonist expects to initiate a Phase 3 study for rusfertide in Q1 2022 and has seen good enrollment in the Phase 2 study of PN-943 for ulcerative colitis. The company maintains sufficient cash reserves of $352.5 million to support operations through 2024.
Protagonist Therapeutics (Nasdaq: PTGX) announced a $7.5 million milestone payment from Janssen Biotech, triggered by the completion of Phase 1 clinical activities for PN-235 (JNJ-2113). This brings the total milestones earned from the collaboration with Janssen to $87.5 million. The collaboration focuses on developing multiple oral IL-23 receptor antagonists for various indications, including inflammatory bowel diseases. Protagonist retains rights to co-detail products for ulcerative colitis and Crohn's disease in the U.S.
Protagonist Therapeutics (Nasdaq: PTGX) announced participation in a fireside chat at the Jefferies Next Generation IBD Therapeutics Summit, scheduled for October 19, 2021. Dinesh V. Patel, Ph.D. and Scott Plevy, M.D. will present, with the session available on-demand from 10:45 a.m. EST. Protagonist is advancing multiple peptide-based therapies, including rusfertide (PTG-300) for conditions like polycythemia vera and hereditary hemochromatosis, and a candidate for ulcerative colitis (PN-943). The company operates from Newark, California.
Protagonist Therapeutics has announced that the FDA lifted the clinical hold on its rusfertide studies, allowing the resumption of dosing in all trials. This decision follows Protagonist's submission of comprehensive safety reports and protocol amendments addressing previous safety concerns. The clinical hold was initiated due to a finding of tumors in a mouse model, though no additional cancer cases were identified in the human trials. The company plans to begin a Phase 3 study for polycythemia vera in Q1 2022, highlighting optimism for rusfertide's potential in treating related diseases.
Protagonist Therapeutics announced that an abstract from its Phase 2 study of rusfertide in hereditary hemochromatosis has been selected for oral presentation at The Liver Meeting® 2021. The presentation will take place on November 13, 2021, highlighting clinical proof-of-concept for rusfertide. However, all rusfertide studies are currently on clinical hold imposed by the FDA, and the company is in discussions to determine future steps for the development program. This situation raises concerns about the product's advancement in the market.
Protagonist Therapeutics (Nasdaq: PTGX) announced a clinical hold on its studies for rusfertide following a non-clinical finding indicating potential tumorigenicity in a mouse model. The FDA communicated this hold after observing subcutaneous skin tumors during a 26-week study. Patient dosing for all clinical trials of rusfertide is now on pause, and the company is coordinating with the FDA to update necessary clinical documents and protocols. Protagonist emphasizes its commitment to patient safety while determining the next steps with the FDA.
Protagonist Therapeutics (Nasdaq: PTGX) announced the issuance of inducement awards to two new employees on September 15, 2021. The awards include options to purchase 117,500 shares and restricted stock units (RSUs) for 15,000 shares, with an exercise price of $46.47. The stock options vest over four years, while RSUs vest annually. These awards comply with Nasdaq Marketplace Rule 5635(c)(4) and aim to incentivize new talent. Protagonist continues advancing its pipeline of peptide-based therapies, including rusfertide for polycythemia vera and therapies for ulcerative colitis and Crohn's disease.