NERV - Regulatory Setback For Minerva Neurosciences' Schizophrenia Treatment Candidate FDA Asks For More Data | Benzinga
Minerva Neurosciences Inc (NASDAQ:NERV) shares are trading lower after the FDA issued a Complete Response Letter (CRL) to the company’s marketing application for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
In the CRL, the FDA cited the following clinical deficiencies:
- Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness.
- The application submission lacks data on concomitant antipsychotic administration.
- The NDA submission lacks the data needed to establish that the change in negative symptoms of schizophrenia ...