HONG KONG (dpa-AFX) - Abbisko Therapeutics Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has formally accepted the New Drug Application (NDA) for pimicotinib (ABSK021). Pimicotinib is a novel, orally administered, highly selective, and potent small-molecule inhibitor of the colony-stimulating factor 1 receptor (CSF-1R).
The NDA submission seeks approval for pimicotinib in the systemic treatment of patients with tenosynovial giant cell tumor (TGCT), a rare and debilitating disease. Acceptance of the NDA by the FDA marks a significant milestone for Abbisko Therapeutics as it advances its innovative pipeline of targeted therapies.
Pimicotinib was independently developed by Abbisko Therapeutics and has been licensed to Merck KGaA, Darmstadt, Germany, for worldwide commercialization.
In December 2025, pimicotinib was approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Additional applications are under review by regulatory bodies in other markets.
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