PLN-101095 - (FORTIFY)

Aug. 18, 2026: Pliant Therapeutics (NASDAQ: PLRX) said the FDA granted Fast Track designation to PLN-101095, an oral small-molecule dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for potential treatment of solid tumors resistant to immune checkpoint inhibitors.

PLN-101095 is being evaluated in the Phase 1a/1b FORTIFY trial (NCT06270706), with data expected in 2027. The company also said FORTIFY includes a Phase 1b indication expansion enrolling patients with NSCLC, tumors with high tumor mutational burden, or clear cell renal cell carcinoma.

The release states Fast Track is intended to expedite development and review of drugs for serious conditions and may provide more frequent FDA interactions, rolling NDA submission, and potential priority review eligibility if criteria are met.