Sam is a trader and one of our lead stock analysts at AskTraders. After starting his career predominantly in the forex markets, Sam now focuses on gold and stocks with a preference for 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.
CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage . 75 % of retail investor accounts lose money when trading CFDs with this provider . You should consider whether you understand how CFDs work, and whether you can afford to take the high risk of losing your money .