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Minerva Neurosciences Reports Third Quarter 2020 Financial Results And Business Updates
WALTHAM, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"WALTHAM, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended September 30, 2020. Clinical program update Roluperidone The U.S. Food and Drug Administration (FDA) has granted Minerva a Type C meeting scheduled to take place via teleconference on November 10, 2020. This meeting will provide an opportunity for the Company to review clinical data generated to date with roluperidone, including the recently completed double-blind part of the Phase 3 trial for the treatment of negative symptoms in schizophrenia, and to solicit recommendations from the FDA regarding these data and the readiness of the roluperidone data package to support a New Drug Application submission. The Company expects to provide an update in mid-late December 2020 following receipt of the official minutes of the meeting. “The objective of our upcoming meeting with the FDA is to discuss and define a path forward for roluperidone, Minerva’s lead product,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Negative symptoms continue to represent the leading unmet need in the treatment of schizophrenia, as well as significant symptoms in a number of other psychiatric disorders. Our analyses of the recently announced Phase 3 trial top line results, in conjunction with the database we have generated to date, support our confidence in roluperidone’s potential to be a novel treatment in this space.” Third Quarter 2019 Financial Results Cash Position: Cash, cash equivalents and restricted cash as of September 30, 2020 were approximately $32.6 million. R&D Expenses: Research and development (R&D) expenses for the three and nine months ended September 30, 2020 were $4.6 million and $18.5 million, respectively, compared to $9.7 million and $29.6 million for the same periods in 2019. The decreases in R&D expenses primarily reflect lower development expenses for the Phase 3 clinical trial of roluperidone and the completion of the Phase 2b clinical trial of MIN-117 in December 2019. The Company expects R&D expenses to decrease during 2020 as compared to 2019 following the completion of the MIN-117 clini...