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News about Protagonist Therapeutics, Inc. (NASDAQ: PTGX) centers on its progress as a discovery-through-late-stage development biopharmaceutical company advancing peptide-based drug candidates. Company announcements frequently highlight clinical and regulatory milestones for its lead investigational therapies, icotrokinra and rusfertide, as well as updates from its broader pipeline and collaborations.
Investors following PTGX news will see regular coverage of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. Press releases describe data from Phase 3 ICONIC studies in moderate-to-severe plaque psoriasis, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2, as well as the Phase 2b ANTHEM-UC trial in ulcerative colitis. News items also report on regulatory submissions, such as the New Drug Application to the U.S. FDA and an application to the European Medicines Agency for plaque psoriasis.
Coverage of rusfertide focuses on its development for polycythemia vera in collaboration with Takeda. News releases describe Phase 3 VERIFY study results, long-term extension data from THRIVE, and the submission of a New Drug Application to the FDA for adults with polycythemia vera. These updates often include details on hematocrit control, phlebotomy requirements, patient-reported outcomes, and regulatory designations such as Breakthrough Therapy, Orphan Drug, and Fast Track status.
Additional PTGX news includes presentations at major medical and scientific conferences, such as the American Society of Hematology Annual Meeting, European Academy of Dermatology and Venereology Congress, American College of Gastroenterology meeting, and the J.P. Morgan Healthcare Conference. The company also issues periodic financial result and corporate update releases, which summarize recent clinical achievements, collaboration developments with Johnson & Johnson and Takeda, and progress in earlier-stage programs like PN-881, PN-477, and the oral hepcidin initiative.
For readers tracking PTGX, this news stream provides insight into Protagonist’s clinical data, regulatory interactions, partnership activities, and pipeline evolution as described in its own public communications.
Protagonist Therapeutics has appointed Dr. Arturo Molina as Chief Medical Officer, effective November 7, 2022. Dr. Molina, an accomplished hematologist-oncologist, will lead the Phase 3 VERIFY study of rusfertide for polycythemia vera and enhance the company’s clinical and operational strategies. His prior experience includes roles at Sutro Biopharma and Johnson & Johnson, underscoring a strong track record in clinical development. The focus on rusfertide's potential to transform treatment highlights the company’s commitment to advancing innovative therapies.
Protagonist Therapeutics (Nasdaq: PTGX) announced an inducement award for newly hired Vice President of Pharmacovigilance, Dr. Pedro Oyuela, on September 15, 2022. The award includes an option to purchase 35,000 shares at an exercise price of $8.27, the closing price on the grant date. The shares will vest over four years, with 25% vesting after one year and the remainder in equal monthly installments. This grant complies with Nasdaq rules and aims to incentivize Dr. Oyuela's employment.
Protagonist Therapeutics (PTGX) reported its Q2 2022 financial results with a net loss of $41.0 million, or $0.84 per share, compared to a loss of $30.8 million in Q2 2021. The company's cash position remains strong, totaling $291.9 million, sufficient to fund operations until the end of 2024. Protagonist is advancing its Phase 3 VERIFY study of rusfertide in polycythemia vera, with 35 sites activated globally despite slower initial enrollment. Additionally, the company is pursuing clinical development for its other candidates, PN-235 and PN-943, showcasing a commitment to innovation.
Protagonist Therapeutics (PTGX) announced an inducement award granted to newly appointed Vice President, Controller, Karen Peterson, on July 15, 2022. The award includes an option to purchase 25,000 shares at an exercise price of $9.46, reflecting the closing price on that date. The stock options will vest over four years, with 25% vesting after the first year and the rest monthly thereafter. This grant aligns with Nasdaq rules and aims to incentivize Peterson's employment with the company, which focuses on peptide-based drug development, including its lead candidate rusfertide in a Phase 3 study.
Protagonist Therapeutics (Nasdaq: PTGX) announced that CEO Dinesh V. Patel, Ph.D., will present at the Jefferies Healthcare Conference in New York on June 8, 2022, at 9:30 a.m. ET. A webcast of the event will be available for 90 days on the company's Investors website.
The company is advancing peptide-based therapeutics including rusfertide, currently in trials for polycythemia vera, and PN-943, which is moving towards Phase 3 studies. Protagonist has also partnered with Janssen on oral IL-23 receptor antagonists, focusing on the development of PN-235 for psoriasis treatment.
Protagonist Therapeutics (PTGX) announced the completion of enrollment and resumption of dosing in the Phase 2 REVIVE study of rusfertide for polycythemia vera (PV) patients. Following a temporary hold, rusfertide restored therapeutic benefits, including effective hematocrit control and reduced red blood cell count. Notably, approximately 85% of patients resumed treatment after the hold, demonstrating rusfertide's rapid therapeutic effect. The results will be presented at the ASCO 2022 Annual Meeting on June 7, highlighting its potential as a transformative treatment for PV.
Protagonist Therapeutics (PTGX) reported its Q1 2022 financial results, highlighting significant developments in its clinical pipeline. The Company initiated the Phase 3 VERIFY study for rusfertide in polycythemia vera and presented positive Phase 2 results for PN-943 in ulcerative colitis. Protagonist received a $25 million milestone from Janssen for the PN-235 psoriasis study. As of March 31, 2022, the Company had $305.3 million in cash and equivalents, sufficient to fund operations through 2024. However, the net loss for the quarter was $20.9 million, improving from $24.0 million in Q1 2021.
Protagonist Therapeutics (PTGX) announced positive results from its Phase 2 IDEAL study of PN-943, an oral treatment for moderate-to-severe ulcerative colitis. The 150 mg twice-daily dose achieved a 27.5% clinical remission, exceeding the 14.5% of the placebo group, and demonstrated significant efficacy across various endpoints. The company plans to initiate a Phase 3 registrational study based on these findings, further validating its gut-restricted alpha-4-beta-7-integrin antagonist approach. Investors can listen to a conference call today at 6:00 p.m. ET.
Protagonist Therapeutics (Nasdaq: PTGX) announced on April 18, 2022, the issuance of inducement awards to three new employees, including Executive Vice President and CFO Asif Ali. The awards consist of options to purchase 82,500 shares and RSUs for 13,750 shares, with an exercise price of $19.19. These awards fall under the Amended and Restated Inducement Plan approved by the Board. Protagonist is advancing its clinical pipeline, including rusfertide, currently in multiple Phase 2 and Phase 3 trials for conditions like polycythemia vera and ulcerative colitis.
Alpha Cognition Inc. (TSX-V: ACOG) announced the appointment of Don Kalkofen as Chief Financial Officer, replacing Jeremy Wright, who will remain as a consultant. Kalkofen has extensive experience in biotechnology finance, most recently as CFO at Protagonist Therapeutics (NASDAQ: PTGX), where he facilitated over $550 million in financing. He will lead Alpha Cognition's financial operations and support strategic growth. In conjunction with his appointment, Kalkofen received 450,000 stock options at $0.93 CAD. CEO Michael McFadden was also appointed to the board of directors.