Syntara Limited (ASX: SNT), a clinical-stage biotechnology company focused on developing first-in-class treatments in blood cancers and other fibrotic diseases, today announces 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.
Highlights:
- US FDA Fast Track designation granted for Syntara’s SNT-5505 for the treatment of myelofibrosis
- Fast Track designation enables more frequent FDA interaction, eligibility for Priority Review and discussions on accelerated approval
- Reflects significant unmet medical need in myelofibrosis, a serious blood cancer with limited treatment options
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.”
