Sam is a professional trader and the lead stock market news writer at AskTraders. After starting his career in the forex market, Sam now focuses on gold and stocks with a preference for fundamental and macroeconomic analysis.
Biopharmaceutical company, Minerve Neurosciences (NASDAQ: NERV) shares are down over 23% on Tuesday after the company announced the outcome of its Type C meeting with the US Food and Drug Administration (FDA).
The subject of the meeting, on November the 10th, was the development of roluperidone for treatment of negative symptoms in schizophrenia.
In its press release, Minerva said that the FDA advised that:
Minerva stated the FDA did acknowledge that data from its Phase2b and 3 study show promising signs and that they encouraged the company to continue the development of the drug.
“We plan to communicate with FDA regarding their comments about the Phase 2b study and continue to move forward with the clinical pharmacology, non-clinical, and CMC work needed to support an NDA submission,” said Dr Remy Luthringer, CEO of Minerva.
“Following completion of the open-label extension of the Phase 3 study, we expect to request a pre-NDA meeting with FDA to discuss the NDA submission plans based on the clinical efficacy and safety data.”
Minerva’s stock price is 23.65% lower so far today, priced at $2.97.
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