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Sat, Jul 12, 2025

Breakthrough therapy

Home » Topics » Regulatory » Breakthrough therapy
  • Knee pain illustration
    June 10, 2025
    By Karen Carey

    Allay’s $57.5M extends postsurgical pain relief with ATX-101

    As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner.
  • Knee pain illustration
    June 6, 2025
    By Karen Carey

    Allay’s $57.5M extends postsurgical pain relief with ATX-101

    As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
  • Vykat xr
    March 27, 2025
    By Karen Carey

    First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

    Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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