Neuphoria's Social Anxiety Drug Fails Phase III Trial, Company Initiates Strategic Review

Neuphoria Therapeutics announced that its lead candidate for social anxiety disorder, BNC210 (soclenicant), failed to meet its primary endpoint in a late-stage clinical trial. The disappointing results have prompted the company to discontinue its social anxiety disorder program and launch a strategic review of its business operations.

Trial Results and Program Discontinuation

The phase III AFFIRM-1 trial evaluated a single 225-mg dose of BNC210, an α7 nicotinic receptor negative alteration modulator, against placebo for the acute treatment of social anxiety disorder. The study's primary endpoint, which measured change from baseline on a distress scale during a public speaking challenge, was not achieved. Additionally, the trial failed to demonstrate statistically significant changes on secondary endpoints, including self-assessments and clinician-measured assessments.

Despite the setback, Neuphoria reported that the safety and tolerability profile of BNC210 remained favorable. The company had previously touted the candidate's potential to provide rapid stress relief without common side effects associated with currently approved treatments, such as sedation or cognitive impairment.

Dr. Spyros Papapetropoulos, President and CEO of Neuphoria, stated, "We plan to immediately take action to conserve our cash position by holding further investment in our programs and evaluating all options for Neuphoria's path forward through a strategic review, with the goal of maximizing value for shareholders."

Impact on Neuphoria and Future Plans

The news of the failed trial has had a significant impact on Neuphoria's stock, which plummeted 67% following the announcement, dropping from $15.40 per share to $5 as of 10 a.m. ET on October 21, 2025.

While the company is discontinuing its social anxiety disorder program, it plans to assess next steps for BNC210 in post-traumatic stress disorder (PTSD). Neuphoria cited "previous positive data with chronic daily dosing" as a reason to continue evaluating the molecule for PTSD treatment. In December 2024, the company reported positive effects on PTSD symptoms at 12 weeks in a phase IIb trial, with indications of efficacy even within four weeks.

As of June 30, 2025, Neuphoria had $14.2 million in cash and cash equivalents, which was expected to fund operations through the second fiscal quarter of 2027. The company plans to provide an update on its strategic review by the end of 2025.

Industry Implications and Competitive Landscape

The failure of Neuphoria's social anxiety disorder program may have implications for the broader pharmaceutical industry. William Blair analysts questioned the trial's design and the pharmacokinetics of the drug, noting that Phase I data showed BNC210 at a 300mg dose takes 2 hours in a fasted state to achieve maximum plasma concentration, yet the public speaking challenge was conducted 60 minutes after taking either active drug or placebo.

Attention now turns to VistaGen, which analysts identify as the only other company running pivotal-stage clinical trials for social anxiety disorder. VistaGen is currently testing an inhaled pherine spray called fasedienol, with data from the phase III PALISADE-3 trial expected to read out this quarter. The different mechanism of action and delivery method of fasedienol could potentially differentiate it from Neuphoria's BNC210.

Despite the setback in its social anxiety program, Neuphoria maintains active partnerships with major pharmaceutical companies. The company has an ongoing collaboration with Merck & Co. to advance two positive allosteric modulator candidates, one of which is currently being tested in a Merck-led phase 2 study for Alzheimer's disease. This partnership could potentially yield up to $450 million in milestone payments for Neuphoria. Additionally, the company has a deal with Carina Biotech to develop a legacy oncology program.