Syntara Limited (ASX:SNT) Receives FDA Fast Track Designation for SNT-5505
Regulatory Achievement
Syntara Limited (ASX:SNT) announced that its lead candidate, SNT-5505, has been granted Fast Track designation by the US Food and Drug Administration for treating myelofibrosis in patients with inadequate response to JAK inhibitor therapy. This designation allows more frequent FDA interactions, eligibility for Priority Review and Accelerated Approval, and potential Rolling Review support for a New Drug Application.
Clinical Development
SNT-5505, which inhibits lysyl oxidases, addresses the significant unmet medical need in myelofibrosis, a serious blood cancer affecting approximately 20,000 patients in the US. Clinical studies have demonstrated that SNT-5505 improves patient quality of life with an excellent safety and tolerability profile. The drug is currently undergoing a Phase 2 clinical trial, with additional interim data to be presented at the European Hematology Association meeting on June 14, 2025.
Executive Comments
Gary Phillips, Chief Executive Officer of Syntara, stated: “To have the FDA recognise the quality of the pre-clinical and clinical results generated to date, as well as the therapeutic promise of SNT-5505 through this Fast Track designation, is an outstanding development for Syntara. This supports our efforts to rapidly advance SNT-5505 as a potential new standard of care for patients with myelofibrosis, addressing the noticeable gaps left by existing treatments.”
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended Syntara. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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