Benzinga
Published Feb 27, 2024 17:53
Updated Feb 27, 2024 19:10
Regulatory Setback For Minerva Neurosciences' Schizophrenia Treatment Candidate, FDA Asks For More Data
Benzinga - by Vandana Singh, Benzinga Editor.
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:
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.
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