Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
---|
Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
---|
Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
---|
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:
“We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia, and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva.
In addition to the clinical deficiencies, the FDA also provided comments on, among other items, clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues.
Cash, cash equivalents, and restricted cash at December 31, 2023, were approximately $41.0 million.
Price Action: NERV shares are down 62.1% at $2.55 during the premarket session on the last check Tuesday.
Posted In: NERV