All Focus Shifts To Bionomics' PTSD Study After Anxiety Trial Disappoints

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  • Bionomics Limited BNOX announced results from its Phase PREVAIL study of BNC210 for the acute treatment of Social Anxiety Disorder (SAD), showing a miss on the primary endpoint.
  • HC Wainwright, while downgrading the stock to Neutral from Buy, discussed the history of BNC210 and the PTSD program previously. 
  • The analyst writes that it has received baseline support from models of conditioned fear extinction and clinical effect from enhanced emotional recovery from CCK-induced panic attacks.
  • HC Wainwright says that the formulation works, and encouraging data might help de-risk the ATTUNE study. 
  • Topline data from the Phase 2b ATTUNE study is expected in mid-2023. The indication has also received Fast Track designation for PTSD. The analyst sees the possibility of a Breakthrough Therapy designation as no new therapy has been approved in about 20 years for PTSD.
  • William Blair analyst writes that the investors' focus will shift to the Phase IIb ATTUNE study of BNC210 in post-traumatic stress disorder (PTSD). 
  • The analyst is reducing the probability of success from 55% to 25% while awaiting additional updates regarding whether BNC210 will still be positioned for clinical development in SAD. 
  • It reiterates Outperform rating.
  • Price Action: BNOX shares are trading at $6.80 on the last check Monday.
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