Business
Minerva Neurosciences Reports First Quarter 2024 Financial Results and Business Updates
BURLINGTON, Mass., May 01, 2024 (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":"BURLINGTON, Mass., May 01, 2024 (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 business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. The Company is in discussions with the FDA regarding the issues and clinical deficiencies raised in the CRL. Phase 1b Clinical Trial (MIN-101C18) In the first quarter of 2024, the Company completed a clinical trial initiated in October 2023 to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the co-administration of roluperidone and olanzapine in adult subjects with moderate to severe negative symptoms of schizophrenia. This clinical trial (NCT06107803) was designed to investigate the pharmacodynamic and pharmacokinetic effects and safety of the concomitant therapy of roluperidone with an established and widely used antipsychotic. Of the 17 patients enrolled, 13 completed all 17 days of daily dosing of roluperidone at 64 mg. No new safety signals were observed during the study with few treatment-emergent adverse events (TEAEs), most of which were mild and all resolved without sequelae. No emergent clinically significant electrocardiogram or laboratory abnormalities were observed during the study. There was no symptomatic worsening during the administration of roluperidone alone (7 days) or when administered in combination with olanzapine at 10 mg (10 days). The study demonstrated that pharmacokinetic interactions between the two drugs were not relevant. First Quarter 2024 Financial Results Research and development (R&D) expense: For the three months ended March 31, 2024 and 2023, R&D expense was $4.2 million and $2.7 million, respectively. R&D expense was higher versus the prior year period primarily due to costs associated with the FDA’s review of the Company’s NDA and the conduct of the MIN-101C18 study.General and administrative (G&A) expense: For the three months ended March 31, 2...