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Syntara Wins FDA Backing for Pivotal Amsulostat Trial in Myelofibrosis

Story Highlights
  • Syntara gained FDA support for a Phase 2b myelofibrosis trial, advancing amsulostat into late-stage development.
  • Additional studies and 2026 data readouts across cancer, scarring and neurodegeneration mark a pivotal year for Syntara.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Syntara Wins FDA Backing for Pivotal Amsulostat Trial in Myelofibrosis

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Syntara Limited ( (AU:SNT) ) has shared an announcement.

Syntara has secured positive U.S. FDA Type C meeting feedback endorsing the design of a roughly 100-patient, placebo-controlled Phase 2b trial of its lead drug amsulostat in myelofibrosis patients who have not responded adequately to standard JAK inhibitor therapy. The agency’s support for the study design and wider development pathway positions amsulostat to enter late-stage development, strengthening Syntara’s hand in discussions with potential commercial partners and reinforcing its competitive profile in bone marrow cancers.

The company is also progressing two Phase 1b/2 studies of amsulostat in myelodysplastic syndrome, with interim data expected in the second half of 2026 that could open additional indications and expand the drug’s market potential. Further near-term catalysts in 2026 include top-line data from a Phase 2 trial of SNT-4728 in isolated REM sleep behaviour disorder linked to Parkinson’s disease and results from Phase 1b skin scarring studies of SNT-9465, collectively marking 2026 as a pivotal year for Syntara’s clinical pipeline and strategic positioning.

The most recent analyst rating on (AU:SNT) stock is a Buy with a A$0.19 price target. To see the full list of analyst forecasts on Syntara Limited stock, see the AU:SNT Stock Forecast page.

More about Syntara Limited

Syntara Limited is an ASX-listed clinical-stage drug development company focused on treating blood cancers and diseases driven by inflammation and fibrosis, leveraging expertise in amine oxidase chemistry and extracellular matrix dysfunction. Its lead candidate amsulostat targets myelofibrosis and myelodysplastic syndromes, alongside a broader pipeline including topical pan-LOX inhibitors for scarring, neuroinflammation therapies for Parkinson’s-related disorders, and assets in fibrotic diseases.

Average Trading Volume: 863,085

Technical Sentiment Signal: Sell

Current Market Cap: A$52.3M

See more insights into SNT stock on TipRanks’ Stock Analysis page.

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