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From: Julius Wong4/21/2025 8:32:00 PM
1 Recommendation   of 8255
 
Gene therapy developers rise on comments from FDA's Makary

Apr. 21, 2025 1:50 PM ET
By: Jonathan Block, SA News Editor

  • Companies involved in the development of gene therapies are trading higher Monday after FDA Commissioner Martin Makary made positive comments on the sector in a recent SiriusXM interview on "The Megyn Kelly Show."
  • Makary discussed a "new pathway" for therapies to treat rare diseases. Gene therapies are among the most promising treatments tackling them.
  • Among the names seeing a boost are: Regenxbio (NASDAQ: RGNX); Beam Therapeutics (NASDAQ: BEAM); Intellia Therapeutics (NASDAQ: NTLA); uniQure (NASDAQ: QURE); Avidity Biosciences (NASDAQ: RNA); and Dyne Therapeutics (NASDAQ: DYN).
  • Discussing a new mechanism-driven pathway, Makary cautioned that it would be focused on diseases impacting "a small number of people."
  • "For biopharma, we believe he came across as scientifically-grounded level-headed with regards to registrational requirements, drug approval processes, and modernizing data capture, and willing to work with industry appropriately," RBC Capital Markets Brian Abrahams wrote about Makary's comments.
  • Jefferies Michael Yee also weighed in, adding that the commissioner reflected on efforts to reform and accelerate the drug development process, such as streamlining trial requirements and reducing the burden of drug development, particularly for rare diseases.
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