Minerva Neurosciences shares are trading lower after the company announced it received a Complete Response Letter from the FDA for the New Drug Application for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
Portfolio Pulse from Benzinga Newsdesk
Minerva Neurosciences' stock is trading lower following the FDA's issuance of a Complete Response Letter for the New Drug Application of roluperidone, intended to treat negative symptoms in schizophrenia patients.
February 27, 2024 | 2:31 pm
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Minerva Neurosciences' shares are trading lower due to the FDA's Complete Response Letter for roluperidone, impacting its potential market entry.
The FDA's Complete Response Letter is a significant regulatory hurdle, directly impacting Minerva Neurosciences' ability to bring roluperidone to market. This news is likely to negatively affect investor sentiment and the stock price in the short term, as it delays potential revenue from roluperidone and raises concerns about the drug's approval pathway.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100