Earlier today, Bionomics Limited (NASDAQ:BNOX) announced topline results from its Phase 2b ATTUNE trial of BNC210 for post-traumatic stress disorder (PTSD).

The trial met its primary endpoint of change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to Week 12 (p=0.048). 

HC Wainwright upgraded the stock from Neutral to Buy with a price target of $8.

With the SAD pivotal start garnering considerable attention, the management's priority shifts towards initiating discussions with the FDA in the latter half of 2024 to outline the subsequent phases of the PTSD program. 

BNC201's characteristics hold promise in a broader context, potentially offering healthcare providers and patients valuable applications in both acute and chronic scenarios. 

HC Wainwright notes that securing a Breakthrough Therapy designation is now within reach, given the absence of any newly approved therapies for PTSD over the past two decades.

William Blair says this marks a substantial victory for Bionomics, as it has demonstrated statistically significant efficacy signals across various measures and time points. 

Although there are some concerns regarding potential liver issues, the absence of observed liver injury is reassuring, indicating that this challenge can be effectively addressed by considering a slightly lower dosage in upcoming studies. 

The analyst maintains a positive outlook, reiterating an Outperform rating on the company's shares.

Price Action: BNOX shares are up 310.70% at $4.05 on the last check Thursday.