PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) announces today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML). AB8939 had already obtained orphan drug designation from the US Food and...
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PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) today announced that the confirmatory Phase 3 study with masitinib in amyotrophic lateral sclerosis (ALS), study AB23005, has been authorized by the first set of European countries (Spain, Greece, Slovenia) in Step 2 of the Clinical Trials Information System (CTIS)...
PARIS, France – AB Science SA today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e. a medical use patent) with its lead compound masitinib, based on findings from study AB06006. This new European patent...
PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) today announced the approval of the third of four stages of the Phase I/II study (AB18001) with the compound AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML). The third stage has been approved in France, Germany, Spain...
PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) today announced the publication of a new article on the preprint platform bioRxiv. This article is entitled ‘Identification of AB8939, a novel synthetic microtubule destabilizer and ALDH inhibitor that overcomes multidrug resistance in tumor cells as a drug candidate for...
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. announced the completion of patient enrollment for its pivotal Phase III trial, MANEUVER (ABSK021-301) STUDY, for evaluating the efficacy and safety of pimicotinib in patients with tenosynovial giant cell tumor (TGCT). A total of 94 patients were enrolled and exceeded the original target...
SHANGHAI — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023. The two clinical updates include reporting the design of...
SHANGHAI, China — Abbisko Therapeutics announced that its investigational innovative CSF-1R inhibitor pimicotinib（ABSK021) has been granted orphan drug designation by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Following the successful ODD granted by the EMA, the product will benefit from incentives, including...
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT). Pimicotinib is the first...
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter, HKEX code: 02256.HK) today announced that the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively...