Protagonist Ther Stock Price, News & Analysis

Protagonist Therapeutics (Nasdaq: PTGX) has received FDA's Breakthrough Therapy Designation for rusfertide, aimed at treating polycythemia vera (PV) by reducing erythrocytosis. This designation, granted on June 3, 2021, accelerates development for serious conditions and is based on promising Phase 2 trial data showing significant patient improvements. Rusfertide is positioned as the first non-cytoreductive therapy for PV. Protagonist plans to expedite clinical studies, and updated data will be presented at the European Hematology Association meeting from June 9-17, 2021.

Protagonist Therapeutics (PTGX) announced the dosing of the first human subject in a Phase 1 study for PN-232, an oral interleukin-23 receptor antagonist peptide. This trial aims to assess safety, tolerability, and pharmacokinetics. The study consists of three parts: single ascending doses, multiple ascending doses, and food effect evaluations. Protagonist is collaborating with Janssen Biotech, which will handle development past Phase 2. The company may receive milestone payments and has options for product co-detailing in the U.S.

Protagonist Therapeutics (PTGX) announced that its abstract on updated data from the Phase 2 trial of rusfertide for polycythemia vera has been selected for oral presentation at the EHA 2021 Annual Congress from June 9-17, 2021. The study showed significant results, including the elimination of therapeutic phlebotomy needs and improved iron levels in patients. The presentation will be available on-demand starting June 11, 2021, and aims to further establish the efficacy of rusfertide in managing PV.

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.