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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 (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.
Protagonist Therapeutics (PTGX) announced plans to initiate a global Phase 3 clinical trial for rusfertide (PTG-300), targeting polycythemia vera (PV). The FDA provided key feedback, and the EMA expressed support for its clinical development plan. The Phase 3 study will enroll 200-250 adult participants, focusing on the proportion achieving response defined by hematocrit control. Secondary endpoints will include symptoms and phlebotomy frequency. The trial aims to address unmet needs in PV treatment, paving the way for future drug applications in the U.S. and Europe.
Protagonist Therapeutics (Nasdaq: PTGX) reported its financial results for Q4 2020, highlighting significant growth in its pipeline. The company received orphan drug and Fast Track designations for rusfertide in polycythemia vera (PV), affecting approximately 100,000 patients in the U.S. Protagonist aims to finalize its clinical development plan for rusfertide by mid-2021. The company raised $255 million through various public offerings in 2020, ending the year with $307.8 million in cash and equivalents. However, it reported a net loss of $66.2 million for the full year 2020.
Protagonist Therapeutics (Nasdaq: PTGX) will host a conference call on March 10, 2021, at 4:30 PM ET to discuss its Q4 and full year 2020 financial results. The call can be accessed via phone at 1-844-515-9178 (U.S.) or 1-614-999-9313 (International), with conference ID #: 7756175. A live webcast will also be available on the company's website. Protagonist is developing several peptide-based therapeutics, including PTG-300 and PTG-200, currently in various stages of clinical trials.
Protagonist Therapeutics, Inc. (NASDAQ:PTGX) will participate in the virtual H.C. Wainwright Global Life Sciences Conference from March 9 to 10, 2021. CEO Dinesh V. Patel, Ph.D., will engage in a fireside chat on March 9, starting at 7:00 a.m. EST, with a subsequent opportunity for one-on-one meetings with investors. A webcast of the event will be available for 90 days. Protagonist is advancing multiple peptide-based therapeutics, including PTG-300 and PTG-200, targeting various conditions such as polycythemia vera and Crohn's disease.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) announced the issuance of an inducement award to Jami Taylor, newly appointed Vice President of Corporate Affairs, on February 26, 2021. The award includes an option to purchase 50,000 shares at an exercise price of $23.57, the closing price on the grant date. The shares vest over four years. This grant is part of the Amended Inducement Plan adopted on May 29, 2018, reflecting the company's commitment to attract top talent. Protagonist is focused on developing peptide-based therapeutics for significant unmet medical needs.
Protagonist Therapeutics, Inc. (NASDAQ: PTGX) will participate in the SVB Leerink Virtual 10th Annual Global Healthcare Conference from February 22 to 26, 2021. Dinesh V. Patel, Ph.D., President and CEO, is scheduled for a fireside chat on February 24, 2021, at 10:40 a.m. EST. The event will be available for live and archived viewing on the company’s website. Protagonist, based in Newark, California, focuses on innovative peptide-based therapeutics, with several candidates in clinical trials for conditions like Crohn's disease and polycythemia vera.
Protagonist Therapeutics, Inc. (Nasdaq:PTGX) announced the issuance of an inducement award to Dr. Paula O'Connor, recently appointed as Senior Vice President of Clinical Development. This award includes an option to purchase 75,000 shares of the company’s common stock at an exercise price of $20.71, the closing price on January 29, 2021. The award is designed as a recruitment incentive, with shares vesting over four years. Protagonist Therapeutics focuses on developing peptide-based therapeutics for various medical conditions, with several candidates currently in clinical trials.
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