Abbisko’s TGCT Drug Pimicotinib Wins FDA NDA Acceptance After Strong Phase III Data

An update from Abbisko Cayman Limited ( (HK:2256) ) is now available.

Abbisko Cayman Limited announced that its subsidiary Abbisko Therapeutics has had its New Drug Application for pimicotinib, an orally administered and highly selective CSF-1R inhibitor for the systemic treatment of tenosynovial giant cell tumor, formally accepted by the US Food and Drug Administration. Pimicotinib, already approved in China and licensed globally to Merck KGaA, Darmstadt, Germany, is backed by positive Phase III MANEUVER trial data showing statistically significant improvements in tumor response and patient-reported outcomes, positioning the drug as a potential new once-daily standard of care for TGCT and marking a major milestone in Abbisko’s international expansion despite the company’s caution that ultimate commercialization is not guaranteed.

The most recent analyst rating on (HK:2256) stock is a Hold with a HK$15.00 price target. To see the full list of analyst forecasts on Abbisko Cayman Limited stock, see the HK:2256 Stock Forecast page.

More about Abbisko Cayman Limited

Abbisko Cayman Limited is a Cayman Islands–incorporated biopharmaceutical group whose subsidiary Abbisko Therapeutics focuses on developing innovative small-molecule drugs, including targeted therapies for oncology and rare diseases. Its pipeline includes pimicotinib, a highly selective CSF-1R inhibitor aimed at addressing unmet medical needs in tenosynovial giant cell tumor (TGCT) and other markets through both in-house development and global commercialization partnerships.

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Technical Sentiment Signal: Buy

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