Business
Minerva Neurosciences Reports Second Quarter 2022 Financial Results and Business Updates
Company Continues to Prepare for Potential Submission of an NDA for Roluperidone in the Third Quarter of 2022WALTHAM, Mass., Aug. 09, 2022 (GLOBE NEWSWIRE) --
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Company Continues to Prepare for Potential Submission of an NDA for Roluperidone in the Third Quarter of 2022WALTHAM, Mass., Aug. 09, 2022 (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 June 30, 2022. Roluperidone Update Following the March 2, 2022 Type C Meeting with the Food and Drug Administration (FDA), the Company issued a press release on April 7, 2022, providing an update and an outline of next steps in preparation for the anticipated submission of a New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in schizophrenia. Following the press release, the Company hosted a webcast on April 13, 2022, which is archived and can be accessed under “Events and Presentations” in the Investors and Media section of the Company’s website. Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences said, “Following the Type C meeting last quarter, we continue to be encouraged by our interactions with the FDA and we are preparing our NDA, which is on track for potential submission during the third quarter of 2022. With no treatments currently approved in the US for negative symptoms of schizophrenia, we are committed to addressing this critical need and believe that roluperidone has the potential to improve the lives of people impacted by negative symptoms.” Minerva has conducted two adequate and well controlled studies for the intended indication and is of the opinion that the data from these studies are sufficient to support a marketing application. Following the Type C meeting, the Company submitted additional data to the FDA to address certain matters discussed at the meeting. Second Quarter 2022 Financial Results At the annual meeting of shareholders held on June 10, 2022 shareholders approved a 1 for 8 reverse stock split of the Company’s common stock. The per share numbers below reflect the reverse stock split for both current and comparable prior periods. Net Loss: Net loss was $8.7 million for the three months ended June 30, 2022, or net loss per share of $1.63 (basic and diluted), as compared to net loss for the three months ended June 30, 2...