FDA Feedback Pushes Back Syntara Myelofibrosis Drug Candidate Commercial Launch by Around Two Years, Euroz Hartleys Says

MT Newswires Live
2025/08/12

The US Food and Drug Administration's (FDA) feedback to Syntara (ASX:SNT) pushes back the assumed commercial launch for its amsulostat drug candidate in the treatment of myelofibrosis by around two years., Euroz Hartleys said in a note on Tuesday.

Syntara received formal feedback from the FDA on the clinical pathway for amsulostat. The regulator took a more conservative stance, recommending a standalone, placebo-controlled phase 2b trial, rather than moving directly into the originally planned phase 2c/3 study.

The feedback does not alter Amsulostat's clinical profile, the strength of Syntara's broader pipeline, or its ability to secure a partner, the investment firm noted.

This new timeline reduces near-term spending requirements and extends its cash runway into 2027.

The investment firm maintained its rating at speculative buy and lowered its price target to AU$0.22 per share from AU$0.33 per share.

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