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

MT Newswires Live
Aug 12, 2025

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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