U.S. markets closed
  • S&P 500

    4,662.85
    +3.82 (+0.08%)
     
  • Dow 30

    35,911.81
    -201.79 (-0.56%)
     
  • Nasdaq

    14,893.75
    +86.95 (+0.59%)
     
  • Russell 2000

    2,162.46
    +3.02 (+0.14%)
     
  • Crude Oil

    84.25
    +0.43 (+0.51%)
     
  • Gold

    1,818.00
    +1.50 (+0.08%)
     
  • Silver

    22.95
    +0.03 (+0.14%)
     
  • EUR/USD

    1.1419
    +0.0004 (+0.03%)
     
  • 10-Yr Bond

    1.7720
    +0.0610 (+3.57%)
     
  • GBP/USD

    1.3678
    -0.0001 (-0.01%)
     
  • USD/JPY

    114.4250
    +0.2250 (+0.20%)
     
  • BTC-USD

    43,001.90
    +43.94 (+0.10%)
     
  • CMC Crypto 200

    1,036.83
    +11.10 (+1.08%)
     
  • FTSE 100

    7,542.95
    -20.90 (-0.28%)
     
  • Nikkei 225

    28,318.54
    +194.26 (+0.69%)
     

Decibel Therapeutics' Hearing Loss Gene Therapy Receives FDA Orphan Drug Tag

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • The FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to Decibel Therapeutics Inc (NASDAQ: DBTX) lead gene therapy product candidate, DB-OTO, for otoferlin-related congenital hearing loss.

  • The Company looks forward to initiating a Phase 1/2 trial of DB-OTO in pediatric patients in 2022.

  • Decibel may be eligible to receive one priority review voucher, which could be redeemed to receive priority review for a subsequent marketing application for a different product or sold or transferred to another sponsor.

  • DB-OTO is a dual-vector adeno-associated virus gene therapy product candidate designed to restore hearing in patients with congenital hearing loss caused by mutations in the otoferlin gene.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: DBTX stock is up 3.36% at $7.97 during the market session on the last check Thursday.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.