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Business Earnings Report

Protagonist Therapeutics Reports Q4/FY25 Results, NDA Filings

Analysis based on 7 articles · First reported Feb 25, 2026 · Last updated Feb 25, 2026

Sentiment
20
Attention
4
Articles
7
Market Impact
Direct
Live prominence charts, article sentiment distribution, and event development timeline available on the NewsDesk Dashboard

The market is impacted by Protagonist Therapeutics' financial results, which show a net loss but also significant pipeline advancements and anticipated regulatory approvals. The potential commercial launches of ICOTYDE and rusfertide, along with the company's strong cash position, suggest future growth for Protagonist Therapeutics and could influence investor sentiment in the biotechnology sector.

Biotechnology Pharmaceuticals

Protagonist Therapeutics reported its financial results for the fourth quarter and full year ended December 31, 2025, showing a net loss for both periods. Despite the losses, the company highlighted significant progress in its pipeline, including successful Phase 3 outcomes and the submission of New Drug Applications (NDAs) for ICOTYDE and rusfertide to the United States===Food and Drug Administration. Protagonist Therapeutics expects a U.S. regulatory decision for ICOTYDE in 2026 and anticipates exercising its right to opt out of a 50:50 profit and loss sharing arrangement with Takeda Pharmaceutical Company for rusfertide in Q2 2026. The company also announced new wholly-owned development candidates and expanded its discovery programs, projecting a cash runway through at least the end of 2028.

100 Protagonist Therapeutics reported financial results and provided corporate update
90 Protagonist Therapeutics filed New Drug Applications for ICOTYDE and rusfertide United States===Food and Drug Administration
85 Protagonist Therapeutics expects to opt out of profit and loss sharing arrangement Takeda Pharmaceutical Company
70 Protagonist Therapeutics announced new wholly owned development candidates
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Protagonist Therapeutics reported its Q4 and full-year 2025 financial results, including a net loss of $44.4 million for Q4 2025 and $130.1 million for the full year. The company anticipates significant growth in the next 12-24 months due to regulatory and commercial milestones for ICOTYDE and rusfertide, and the advancement of its R&D pipeline. They expect to exercise their right to opt out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda Pharmaceuticals in Q2 2026.
Importance 100 Sentiment 30
govactor
The United States===Food and Drug Administration is reviewing the New Drug Applications for rusfertide and ICOTYDE, with potential approvals and commercial launches anticipated in 2026.
Importance 80 Sentiment 0
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Takeda Pharmaceutical Company is a partner with Protagonist Therapeutics for the co-development and potential co-commercialization of rusfertide. Protagonist Therapeutics expects to opt out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda Pharmaceuticals in Q2 2026.
Importance 70 Sentiment 10
per
Dinesh V. Patel, President and CEO of Protagonist Therapeutics, highlighted the company's achievements in 2025, including successful Phase 3 outcomes and NDA filings for ICOTYDE and rusfertide, and expressed optimism for future growth.
Importance 60 Sentiment 20
subs
Johnson & Johnson===Janssen Pharmaceuticals, a Johnson & Johnson company, is licensed to ICOTYDE, a product jointly discovered by Protagonist Therapeutics and Johnson & Johnson scientists. A U.S. regulatory decision for ICOTYDE is anticipated in 2026.
Importance 50 Sentiment 10
stock
Johnson & Johnson is a partner in the development of ICOTYDE, with its subsidiary Johnson & Johnson===Janssen Pharmaceuticals holding the license. Protagonist Therapeutics' collaboration revenue includes milestones from the Johnson & Johnson agreement.
Importance 50 Sentiment 10
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