Biopharma company Bionomics Ltd. (NASDAQ: BNOX) announced that, following an end-of-Phase 2 meeting with the Food and Drug Administration (FDA), the agency supports the entrance of lead drug asset BNC210 -a negative allosteric modulator- targeting acute treatment of Social Anxiety Disorder (SAD) into Phase 3 “registrational” studies.
The clinical-stage biotech firm backed by billionaire Steve Cohen recently completed Phase 2 studies on the compound with positive data. Further, BNC210 holds a previously granted FDA fast-track designation for the acute treatment of SAD.
The upcoming Phase 3 clinical program, which is FDA-agreed and aligns with nonclinical toxicology studies required for registration, would begin dosing in 2024’s first quarter.
President and CEO Dr. Spyros Papapetropoulos says the team is “grateful for FDA’s ...