Investing.com -- PureTech Health PLC (NASDAQ:PRTC) stock fell 8.1% in premarket trading Monday after the company announced feedback from its End-of-Phase 2 meeting with the FDA regarding deupirfenidone for idiopathic pulmonary fibrosis (IPF).
The biotherapeutics company reported that the FDA supports advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway for the drug, which is being developed by its Founded Entity, Celea Therapeutics. Despite this progress, investors appeared concerned about the timeline, as the Phase 3 SURPASS-IPF trial is not expected to begin until the first half of 2026.
The upcoming Phase 3 trial will be a global, randomized, double-blind study comparing deupirfenidone 825 mg three times daily to pirfenidone 801 mg three times daily in adults with IPF not on background therapy. The primary endpoint will measure change in forced vital capacity (FVC) at week 52.
PureTech’s announcement highlighted positive results from the earlier Phase 2b ELEVATE IPF trial, where patients treated with deupirfenidone 825 mg experienced slower lung function decline compared to those on pirfenidone or placebo. Participants on deupirfenidone showed a 91 mL difference in FVC compared to placebo at 26 weeks.
"The forthcoming Phase 3 SURPASS-IPF trial builds on the strong foundation established by the Phase 2b ELEVATE IPF trial, which demonstrated deupirfenidone’s robust and durable treatment effect as a monotherapy and its potential to become a new standard of care," said Sven Dethlefs, CEO of Celea Therapeutics.
Celea Therapeutics expects to finalize financing in early 2026 to support the initiation of the Phase 3 trial, which PureTech believes could complete the data package required for potential registration via the 505(b)(2) pathway if successful.
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