FDA grants Fast Track tag to Bionomics' BNC210 in anxiety related disorders

Dec. 01, 2021 6:27 AM ETBionomics Limited (BNOEF)By: Mamta Mayani, SA News Editor

Headquarters of US Food and Drug Administration (FDA)

Grandbrothers/iStock Editorial via Getty Images

  • Bionomics (OTCQB:BNOEF) announces that the FDA has granted Fast Track designation to the BNC210 development program for the acute treatment of Social Anxiety Disorder (SAD) and other anxiety-related disorders.
  • Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
  • In November 2019, the FDA granted Fast Track designation to the BNC210 program for the treatment of Post-Traumatic Stress Disorder and other trauma-related and stressor-related disorders.
  • Following encouraging results in a previous Phase 2a study in Generalised Anxiety Disorder patients where a single oral dose administration of BNC210 significantly reduced threat-avoidance behaviour and connectivity between the amygdala and the anterior cingulate cortex, BNC210 will be evaluated as an acute, or single-dose, treatment for patients with SAD in a planned Phase 2 clinical trial named the PREVAIL Study that is expected to begin by the end of 2021.
  • Recently, the company has filed for a $25M U.S. IPO.

Recommended For You


To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.