On August 18, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX) reported the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential the treatment of solid tumors that are resistant to immune checkpoint inhibitors (ICIs). PLN-101095 is currently being evaluated in the Phase 1a/1b FORTIFY trial (NCT06270706) with data expected in 2027.
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"While immune checkpoint inhibitors have fundamentally changed the oncology treatment landscape, primary or acquired resistance remains a significant barrier for the majority of patients," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "This Fast Track designation underscores the urgent need for innovative therapies for immune checkpoint inhibitor-refractory solid tumors and recognizes the potential of PLN-101095. We look forward to working closely with the FDA as we advance this program."
FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and non-clinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.
(Press release, Pliant Therapeutics, AUG 18, 2026, View Source [SID1234670218])