WATERTOWN, Mass., Sept. 15, 2026 (GLOBE NEWSWIRE) — Kestrel Therapeutics Inc. (“Kestrel” or the “Company”), a clinical-stage biotechnology company developing next-generation small-molecule inhibitors targeting mutant KRAS, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KST-6051, a potential best-in-class, oral pan-KRAS inhibitor, for the treatment of patients with advanced or metastatic solid tumors harboring KRAS mutations.
Fast Track is a designation created to facilitate the development and expedite the review of drugs intended to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation benefit from more frequent communication with the FDA throughout development, and may be eligible for Accelerated Approval, Priority Review, and rolling review of a New Drug Application (NDA), provided relevant criteria are met.
“FDA Fast Track designation for KST-6051 is an important regulatory milestone for Kestrel, based on the strength of our preclinical data package. This designation will allow us to work more closely with the FDA as we advance KST-6051 through our ongoing Phase 1 study, with the goal of bringing a much-needed treatment option to patients with KRAS-mutant tumors as efficiently as possible,” said Frank Haluska, MD, PhD, President and Chief Executive Officer of Kestrel Therapeutics.
KST-6051 is being evaluated in an ongoing first-in-human (FIH), dose-escalation Phase 1 study, denoted FALCON (NCT07458347) in patients with advanced or metastatic KRAS-mutant solid tumors.