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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) announced the pricing of its underwritten public offering of 5 million shares at $20.00 per share, totaling $100 million in gross proceeds. The offering is expected to close around April 10, 2023. Proceeds will fund continued clinical development of rusfertide and general corporate purposes. Underwriters have the option to purchase an additional 750,000 shares. Major underwriters include J.P. Morgan, Jefferies, and Piper Sandler. The registration statement for the offering was effective as of August 16, 2022.
Protagonist Therapeutics (NASDAQ:PTGX) announced a public offering of $100 million in common stock, with a 30-day option for underwriters to purchase an additional $15 million. The proceeds will fund clinical development of rusfertide and general corporate purposes. The offering is subject to market conditions, with no guarantee of completion or terms. Jointly managed by J.P. Morgan, Jefferies, and Piper Sandler, the offering's registration statement became effective on August 16, 2022. Interested investors should consult the SEC's website for the prospectus.
Protagonist Therapeutics (PTGX) reported positive results from the Phase 2b FRONTIER 1 study of JNJ-2113 for moderate-to-severe psoriasis and the REVIVE study of rusfertide for polycythemia vera, achieving significant endpoints. The FRONTIER 1 study demonstrated a greater proportion of patients achieving PASI-75 responses compared to placebo, with no significant adverse events noted. Financially, Protagonist ended 2022 with $237.4 million in cash, sufficient to fund operations through 2024, despite a net loss of $127.4 million for the year. They are preparing for a Phase 3 study of rusfertide, with potential milestone payments of up to $855 million.
Protagonist Therapeutics (NASDAQ:PTGX) announced positive topline results from the REVIVE study on rusfertide, demonstrating significant improvement in responders (69.2% for rusfertide vs. 18.5% for placebo; p=0.0003). The study focused on patients with polycythemia vera, revealing that 92.3% of rusfertide subjects remained phlebotomy-free. Rusfertide showed no new safety signals and was well tolerated. The results support rusfertide's potential as a transformative option for PV treatment. The company is prioritizing the Phase 3 VERIFY study, aiming to expand its development pipeline for this promising therapeutic.
Protagonist Therapeutics (PTGX) announced positive topline results from the FRONTIER 1 Phase 2b trial of JNJ-2113, an oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis. The study involved 255 patients, showing that JNJ-2113 met its primary endpoint with a statistically significant improvement (PASI-75) at Week 16 compared to placebo across all treatment groups. Treatment was well tolerated, with no notable differences in adverse events. Protagonist anticipates progressing JNJ-2113 to Phase 3 trials, aiming for milestone payments of up to $855 million from its collaboration with Janssen Biotech.
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