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.

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10