Ikena Oncology, Inc. (NASDAQ:IKNA) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for IK-930, in patients with unresectable NF2-deficient malignant pleural mesothelioma (MPM).
IK-930 is currently being investigated in a Phase 1 clinical trial for patients with advanced solid tumors with or without gene alterations in the Hippo pathway.
Sergio Santillana, MD, Chief Medical Officer, commented : "This milestone, combined with the Orphan Drug designation in mesothelioma, further validates our targeted oncology approach to address significant unmet medical needs for difficult-to-treat cancers and supports our goal to advance the development of IK-930 for the patients who potentially could benefit most."
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Earlier in 2022, the FDA granted Orphan Drug designation to IK-930, which supports development of drugs for rare disorders.
Ikena Oncology shares are trading higher at $3.53 in the pre-market session.
