Syntara Says US FDA Provides Guidance for Phase 2 Trial for Myelofibrosis Drug Candidate; Shares Plunge 47%
MT Newswires Live
Aug 11, 2025
Syntara (ASX:SNT) said the US Food and Drug Administration (FDA) provided guidance that a phase 2 trial with a control arm be undertaken for its amsulostat drug candidate for the potential treatment of myelofibrosis to acquire additional safety and efficacy data, focusing on improvements in symptoms and spleen volume reductions, according to a Monday Australian bourse filing.
This data will be used to optimize the design and efficiency of a subsequent pivotal phase 3 trial, the filing said.
The regulator reviewed data from the ongoing open-label trial of amsulostat in combination with ruxolitinib, as well as a proposal for a pivotal registrational study.
The firm's shares plunged 47% in early trading on Monday.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.