FDA granted Breakthrough Therapy designation to denifanstat, a drug developed by Sagimet Biosciences for MASH treatment.

The entities involved

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• mash →

  fast genome and metagenome distance estimation using MinHash

  • Wave Life Sciences is developing WVE-007, an investigational GalNAc-siRNA product, for MASH indications.Wed 12:44

Related events

• Altimmune successfully launched its global Phase 3 trial in MASH and received Breakthrough Therapy Designation from the FDA.Sep 8
• Novo Nordisk's Wegovy received FDA approval for treating MASH, posing a competitive challenge to Madrigal Pharmaceuticals' Rezdiffra.Jun 7
• A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.Sep 2