Pliant Therapeutics Inc. advanced 6% in pre-market trading after the U.S. Food and Drug Administration awarded Fast Track designation to PLN-101095, the company’s oral dual selective inhibitor of αvβ8 and αvβ1 integrins.
The designation covers PLN-101095 in combination with Merck & Co.’s pembrolizumab for patients whose solid tumors have progressed on prior immune checkpoint inhibitor therapy. The FDA’s decision was disclosed via a company press release issued earlier in the session.
PLN-101095 is currently under evaluation in the Phase 1a/1b FORTIFY trial, which is enrolling patients with non-small cell lung cancer, tumors characterized by high tumor mutational burden, and clear cell renal cell carcinoma. Pliant expects to release clinical data from the study in 2027, marking a key milestone in the company’s oncology pipeline following its strategic shift away from fibrosis programs.
The biotech reported cash, cash equivalents and short-term investments of approximately $159.6 million in its most recent quarterly filing, a position the company has stated is sufficient to fund operations through at least the second half of 2028. Pliant’s shares remain well below their 52-week high of $1.95.
The broader market offered no supportive backdrop, with the NASDAQ Composite down more than 1% at the open and the S&P 500 trading in negative territory. No analyst upgrades or competitor-related sentiment appeared to influence the pre-market advance.
