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 (PTGX) announced the pricing of its underwritten public offering of 3,046,358 shares at $37.75 each, totaling approximately $115 million in gross proceeds. The offering's closure is anticipated around June 18, 2021, subject to customary conditions. Underwriters have a 30-day option to purchase an additional 456,953 shares. J.P. Morgan, Jefferies, and Piper Sandler lead this offering. The shares are being offered under a shelf registration filed with the SEC on December 10, 2020, and the accompanying prospectus will be available through designated financial institutions.
Protagonist Therapeutics (PTGX) has announced a public offering of $100 million in shares of its common stock, with a 30-day option for underwriters to purchase an additional 15%. The offering is managed by J.P. Morgan, Jefferies, and Piper Sandler, alongside other firms as co-leads. The offering is subject to market conditions, and there are no guarantees regarding its completion. A related shelf registration statement has been filed with the SEC. This move is part of Protagonist's strategy to leverage funds for its clinical-stage biopharmaceutical operations.
Protagonist Therapeutics (PTGX) has announced updated results from its Phase 2 study of rusfertide for treating polycythemia vera (PV), presented at the EHA 2021 Virtual Congress. The study showed rusfertide effectively maintained hematocrit levels and reduced the need for therapeutic phlebotomies. Positive outcomes included improved patient-reported symptoms and reversal of iron deficiency. The drug's safety profile was favorable, and the company is preparing to advance into Phase 3 trials in early 2022 following FDA's Breakthrough Therapy Designation.
Protagonist Therapeutics (PTGX) announced a conference call on June 11, 2021, to discuss data from its ongoing Phase 2 study of rusfertide in treating polycythemia vera (PV). The study's results will be presented at the European Hematology Association 2021 Annual Congress. Notable participants include Ronald Hoffman, M.D., a key investigator in the trial. Protagonist aims to initiate a global Phase 3 trial based on feedback from regulatory authorities, focusing on efficacy and safety. The call will be accessible to investors and the public.
Protagonist Therapeutics (Nasdaq: PTGX) has received FDA's Breakthrough Therapy Designation for rusfertide, aimed at treating polycythemia vera (PV) by reducing erythrocytosis. This designation, granted on June 3, 2021, accelerates development for serious conditions and is based on promising Phase 2 trial data showing significant patient improvements. Rusfertide is positioned as the first non-cytoreductive therapy for PV. Protagonist plans to expedite clinical studies, and updated data will be presented at the European Hematology Association meeting from June 9-17, 2021.
Protagonist Therapeutics (PTGX) announced the dosing of the first human subject in a Phase 1 study for PN-232, an oral interleukin-23 receptor antagonist peptide. This trial aims to assess safety, tolerability, and pharmacokinetics. The study consists of three parts: single ascending doses, multiple ascending doses, and food effect evaluations. Protagonist is collaborating with Janssen Biotech, which will handle development past Phase 2. The company may receive milestone payments and has options for product co-detailing in the U.S.
Protagonist Therapeutics (PTGX) announced that its abstract on updated data from the Phase 2 trial of rusfertide for polycythemia vera has been selected for oral presentation at the EHA 2021 Annual Congress from June 9-17, 2021. The study showed significant results, including the elimination of therapeutic phlebotomy needs and improved iron levels in patients. The presentation will be available on-demand starting June 11, 2021, and aims to further establish the efficacy of rusfertide in managing PV.
Protagonist Therapeutics (PTGX) reported its Q1 2021 financial results and highlighted significant pipeline developments. The company completed enrollment for its Phase 2 study of rusfertide in polycythemia vera and plans to initiate a Phase 3 study in early 2022 after receiving positive feedback from regulators. License revenue increased to $6.2 million, up from $3.6 million year-over-year, and cash reserves stand at $279.7 million, expected to fund operations until mid-2024. However, R&D expenses rose to $24.2 million, contributing to a net loss of $24.0 million for the quarter.
Protagonist Therapeutics (Nasdaq: PTGX) announced on April 30, 2021, the issuance of an inducement award to Ramesh Bhatt, the newly appointed Vice President of Discovery Biology and Translational Research. The award consists of an option to purchase 45,000 shares at an exercise price of $28.94, vesting over four years. This action is aligned with Nasdaq Marketplace Rule 5635(c)(4) and was approved by the Company's compensation committee. Protagonist is advancing multiple peptide-based therapeutics, including rusfertide, currently in Phase 2 trials for various hematological conditions.
Protagonist Therapeutics (Nasdaq: PTGX) has successfully completed enrollment for its Phase 2 study of rusfertide (PTG-300) in polycythemia vera (PV), exceeding the target of 50 evaluable patients. Those not included will have the chance to participate in the upcoming Phase 3 study. Preliminary data suggests rusfertide can maintain hematocrit levels, reducing thrombotic risks in PV patients. The company plans to present interim findings at a major medical meeting soon and is optimistic about moving into Phase 3 trials in early 2022, backed by regulatory agency support.
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