On June 10, 2025 Syntara Limited (ASX: SNT), a clinical-stage biotechnology company focused on developing first-in-class treatments in blood cancers and other fibrotic diseases, reported that its lead candidate, SNT-5505, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of myelofibrosis in patients with an inadequate response to JAK inhibitor therapy (Press release, Syntara, JUN 10, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/f4d68ff6-99ad-efa0-d705-81378f04fdc1/02955002.pdf [SID1234653779]).
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Fast Track designation can be awarded by the FDA after its review of data demonstrating potential benefit, a mechanistic rationale for efficacy and early clinical evidence. With the published and peer reviewed pre-clinical and clinical data, as well as presentations at preeminent hematology meetings, there is a growing body of evidence supporting SNT-5505.
Fast Track designation aims to expedite the review and development of therapies that address serious conditions and unmet medical needs, facilitating earlier drug approval and patient access. Benefits include:
More frequent meetings and communication with the FDA.
Eligibility for Accelerated Approval and Priority Review, subject to meeting relevant criteria.
Potential for Rolling Review in support of a New Drug Application (NDA).
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."