Minerva Neurosciences faced a setback as the U.S. Food and Drug Administration (FDA) rejected its application for the approval of roluperidone, the lead drug candidate for treating negative symptoms in schizophrenia patients.
Complete Response Letter Issued
The clinical-stage biopharmaceutical company based in Burlington, Mass., received a complete response letter from the FDA. The letter indicated that the application, in its current form, lacks the necessary approval and called for further studies to be conducted.
Insufficient Data
While one study showed statistical significance on the primary efficacy endpoint, the FDA deemed it insufficient to establish substantial evidence of effectiveness. Additionally, the agency highlighted the absence of data on concomitant antipsychotic administration and the necessity for data showcasing the clinical significance of the change in negative symptoms with roluperidone treatment.
Next Steps
Minerva announced its intention to seek a meeting with the FDA to address the issues raised and work towards resolving the feedback provided by the agency.
Trading in Minerva’s shares, which closed at $6.80 on Monday, was halted before market opening on Tuesday.
