Regulatory Setback For Minerva Neurosciences' Schizophrenia Treatment Candidate, FDA Asks For More Data
Portfolio Pulse from Vandana Singh
Minerva Neurosciences Inc (NASDAQ:NERV) faces a regulatory setback as the FDA issues a Complete Response Letter (CRL) for its schizophrenia treatment candidate, roluperidone, citing clinical deficiencies and requesting additional data. The FDA's concerns include insufficient evidence of effectiveness from a single study, lack of data on concomitant antipsychotic administration, and inadequate safety database. Minerva must submit further studies to address these issues. NERV shares plummeted 62.1% to $2.55 in premarket trading.
February 27, 2024 | 5:53 pm
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
Minerva Neurosciences Inc faces a significant regulatory hurdle as the FDA requests additional data for its schizophrenia treatment, roluperidone, leading to a sharp 62.1% drop in its stock price to $2.55.
The FDA's issuance of a Complete Response Letter is a significant regulatory setback for Minerva, indicating serious concerns about the drug's efficacy and safety data. This news directly impacts investor confidence and the company's short-term stock price, as evidenced by the substantial premarket drop. The requirement for additional studies implies further investment and delays in potential revenue, exacerbating the negative outlook.
CONFIDENCE 90
IMPORTANCE 100
RELEVANCE 100