Protagonist Ther Stock Price, News & Analysis

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.

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.