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Abbisko Therapeutics Announces FDA Acceptance of the NDA for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor
The FDA accepted Abbisko’s NDA for pimicotinib based on robust Phase III trial data showing significant tumor response and improved patient outcomes in TGCT.
- On Jan. 12, 2026, Abbisko Therapeutics Co., Ltd., Shanghai announced the U.S. Food and Drug Administration accepted its NDA for pimicotinib , an oral CSF‑1R inhibitor for TGCT.
- Regulators granted Breakthrough Therapy and PRIME designations, supported by robust efficacy and safety outcomes from the global Phase III MANEUVER trial, aiding NDA submission, Abbisko said.
- In the MANEUVER trial, patients treated with pimicotinib achieved a statistically significant improvement in objective response rate assessed by blinded independent review committee using RECIST v1.1, with secondary endpoints showing gains in active range of motion, physical function, stiffness, and pain.
- Abbisko licensed pimicotinib to Merck KGaA for worldwide commercialization; the drug's regulatory status in China is not specified in the source.
- Additional applications are under review by regulatory bodies in other markets as global regulatory submissions progressing address unmet clinical needs for patients with tenosynovial giant cell tumor.
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Abbisko Therapeutics Announces FDA Acceptance of the NDA for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor
SHANGHAI, Jan. 12, 2026 /PRNewswire/ -- 13 January 2026 (Beijing Time), Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) announced today that the New Drug Application (NDA) for its novel, orally administered, highly selective, and potent small-molecule colony-stimulating…
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