Inhibikase Therapeutics Gets FDA's Pre-NDA Meeting For IkT-001Pro

(RTTNews) - Clinical-stage pharmaceutical company Inhibikase Therapeutics, Inc. (IKT) Monday announced that FDA has granted a pre-New Drug Application meeting to be held in January 2024 for IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate.

Pre-NDA Meeting will discuss requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to eight blood and stomach cancer indications. The company said it has completed bioequivalence to 400 mg and 600 mg imatinib mesylate with minimal adverse events.

Imatinib mesylate is currently approved for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia as well as acute lymphoblastic leukemia.

IKT shares are down more than 6 percent in pre-market trading.