Business
Minerva Neurosciences Reports Third Quarter 2021 Financial Results and Business Updates
Company to Host Conference Call Today at 8:30 a.m. ET WALTHAM, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Company to Host Conference Call Today at 8:30 a.m. ET WALTHAM, Mass., Nov. 08, 2021 (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, 2021. Roluperidone Update On November 3, 2021, the Company announced that the U. S. Food and Drug Administration (FDA) denied the company’s request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy for the treatment of negative symptoms in schizophrenia. The Company plans to request a Type C meeting and, subject to the timing of and feedback from the FDA, continues to work towards the submission of a New Drug Application (NDA) in the first half of 2022. On September 30, 2021, the Company completed and announced results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late-stage Phase 2b and Phase 3 trials and the planned commercial formulation. The planned commercial formulation was tested under both fasted and fed conditions. The study met key pharmacokinetic (PK) objectives, and the data demonstrate bioequivalence across the various formulations. Management Team Update In October, the Company promoted Geoff Race, former Executive Vice President, Chief Financial Officer and Chief Business Officer of Minerva, to President. Minerva’s Senior Vice President and Chief Accounting Officer, Frederick Ahlholm, was promoted to Chief Financial Officer. In September, Dr. Ramana Kuchibhatla was appointed Senior Vice President and Head of Research & Development following Dr. Jay Saoud’s retirement and transition to an advisory role. This is a key addition to the Company’s leadership team which will help support forthcoming interactions with the FDA. Third Quarter 2021 Financial Results Net Income/Loss: Net loss was $9.2 million for the third quarter of 2021, or net loss per share of $0.22 basic and diluted, as compared to net loss of $8.1 million, or net loss per share of $0.19 basic and diluted, for the third quarter of 2020. Net loss was $28.6 million for the nine months ended September 30, 2021, or net loss per s...