Pliant wins FDA Fast Track status for PLN-101095 plus Keytruda in ICI-refractory solid tumors

Reuters2026/08/18 12:51

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FDA granted Fast Track designation for Pliant Therapeutics’ PLN-101095 with pembrolizumab for immune checkpoint inhibitor-refractory solid tumors.
Fast Track status can speed development via closer FDA interaction, rolling NDA submission, potential priority review.
PLN-101095 is in the Phase 1a/1b FORTIFY trial; data are expected in 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Pliant Therapeutics Inc. published the original content used to generate this news brief on August 18, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Pliant wins FDA Fast Track status for PLN-101095 plus Keytruda in ICI-refractory solid tumors

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