PureTech Health (LSE:PRTC, NASDAQ:PRTC, OTC:PTCHF) shares rose 4.9% to 128p on Wednesday after the company said it had completed a successful end-of-phase II meeting with the US Food and Drug Administration for deupirfenidone, its lead idiopathic pulmonary fibrosis candidate.
The regulator’s feedback supports advancement into a pivotal phase III trial and confirms the suitability of the streamlined 505(b)(2) regulatory pathway, reducing a major point of uncertainty around the programme.
The forthcoming Phase 3 SURPASS-IPF study, due to begin in the first half of 2026 under PureTech’s founded entity Celea Therapeutics, will compare deupirfenidone head-to-head with pirfenidone over 52 weeks.
The FDA indicated that a single successful phase III trial, supported by the wider dataset, could be sufficient for registration.
The announcement builds on results from the phase IIb ELEVATE-IPF trial, where deupirfenidone slowed lung-function decline versus pirfenidone and placebo and maintained a favourable safety profile. More than 90% of participants entered the open-label extension, with sustained effects out to 52 weeks.