Neuphoria Therapeutics Regains Nasdaq Compliance Amidst Strategic Developments
Neuphoria Therapeutics Inc. has successfully regained compliance with Nasdaq's Minimum Bid Price Requirement, ensuring its continued listing on the exchange. The company, which recently re-domiciled from Australia to Delaware, is advancing its clinical trials, including phase 3 trials for BNC210, a treatment for social anxiety disorder and post-traumatic stress disorder. This development marks a significant milestone for Neuphoria Therapeutics, highlighting its commitment to overcoming financial and regulatory challenges while focusing on innovative medical treatments.
Bionomics' BNC210 Shows Positive Phase 2 Results in PTSD Patients, Phase 3 Planned
• Bionomics' BNC210 demonstrated statistically significant improvement in PTSD symptom severity compared to placebo at Week 12, with benefits observed as early as Week 4.
• The Phase 2 ATTUNE study also revealed clinically meaningful improvements in depressive symptoms and sleep quality among patients treated with BNC210.
• Bionomics is advancing BNC210 to a Phase 3 trial for PTSD, slated to begin in the second half of 2025, following positive FDA feedback.
• BNC210 is also under evaluation in a Phase 3 trial for social anxiety disorder (SAD), with results expected in Q3 2025.
BNC210 Shows Promise in Phase IIb Trial for PTSD Treatment
• A Phase IIb trial of BNC210, a novel α7 nicotinic acetylcholine receptor modulator, demonstrated significant improvement in PTSD symptom severity as early as 4 weeks.
• The study showed that BNC210 significantly reduced PTSD symptoms at week 12 compared to placebo, with a Cohen's d effect size of 0.40 (P = 0.048).
• BNC210 was also associated with reduced depressive symptoms and improved sleep, although a higher rate of adverse events led to more discontinuations compared to placebo.
• The FDA has granted BNC210 fast track designation, and a Phase III trial is planned to further evaluate its efficacy and safety in PTSD patients.
Bionomics Advances BNC210 Phase 3 Trial for Social Anxiety Disorder and Strategic Partnership with Merck
• Bionomics initiates Phase 3 trial for BNC210 in social anxiety disorder (SAD) after successful regulatory interactions and IP portfolio expansion, with data readout anticipated in Q3 2025.
• The company is advancing a strategic partnership with Merck & Co. for α7 receptor PAMs targeting cognitive dysfunction in Alzheimer’s disease, expected to enter Phase 2 soon.
• Bionomics is redomiciling to the U.S. and launching Neuphoria Inc., focusing on CNS pipeline development, while maintaining its Australian presence and potential tax benefits.
• BNC210 holds FDA Fast Track designations for SAD and PTSD, showcasing a favorable safety profile and positive datasets across multiple anxiety and stress-related indications.
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