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 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.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) announced the appointment of Scott Plevy, M.D., as Executive Vice President and Therapeutic Head for Gastroenterology. Dr. Plevy, a gastroenterologist with extensive experience in clinical research, will oversee the company's gastrointestinal programs, including the ongoing Phase 2 study of PN-943 for ulcerative colitis. Protagonist aims to address unmet medical needs in GI diseases, leveraging Dr. Plevy's expertise to enhance its development pipeline.
Protagonist Therapeutics (PTGX) has successfully resolved a dispute with Zealand Pharma regarding their 2012 Collaboration Agreement, significantly reducing future milestone payments and royalties for the product candidate rusfertide. The agreement reduces these payments by 50%, excluding $2.5 million in near-term milestones. Protagonist will also make a $1.5 million payment to Zealand in August 2022. This resolution follows arbitration proceedings initiated by Protagonist in 2020 and is expected to streamline the financial obligations related to rusfertide's development.
Protagonist Therapeutics (PTGX) reported substantial progress in Q2 2021, achieving significant milestones in its clinical trials. Key updates include the completion of enrollment for its Phase 2 study of rusfertide in polycythemia vera, which received FDA Breakthrough Therapy Designation. Financially, the company raised approximately $132.2 million from a public offering. However, license revenues decreased to $2.3 million, and R&D expenses rose to $26.4 million. The net loss was $30.8 million, or $0.69 per share, compared to a previous loss of $19.4 million. Future milestones include Phase 3 studies set for early 2022.
Protagonist Therapeutics (Nasdaq: PTGX) announced an amended collaboration with Janssen Biotech for the development of oral Interleukin-23 receptor antagonists, including PTG-200, PN-232, and PN-235. The revised agreement potentially enables Protagonist to earn $900 million in future milestones, in addition to $80 million already received. Janssen assumes financial responsibility for future studies, reducing Protagonist's development obligations. This collaboration supports the advancement of innovative treatments for Crohn's disease and other indications.
On June 30, 2021, Protagonist Therapeutics (Nasdaq: PTGX) granted an inducement award to Patrick Smith, the new Vice President of Quality Assurance, as part of his employment agreement. The award includes an option to purchase 45,000 shares at an exercise price of $45.05, the stock’s closing price on that date. Shares will vest over four years, with 25% vesting after the first year. This award adheres to Nasdaq rules and aims to incentivize Mr. Smith's role within the company. Protagonist develops peptide-based therapeutics, including treatments for polycythemia vera and ulcerative colitis.
Protagonist Therapeutics (Nasdaq:PTGX) has successfully closed a public offering of 3,503,311 shares at $37.75 per share, raising approximately $132.2 million in gross proceeds. This includes 456,953 shares sold due to the underwriters' full exercise of their green shoe option. The offering's strategic execution involved J.P. Morgan, Jefferies, and Piper Sandler as joint book-running managers. The final prospectus has been filed with the SEC, and more details can be accessed via the agency's website.
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