MIN-117 / Mitsubishi Tanabe, Minerva Neurosciences - LARVOL DELTA

Tolerability and safety of high-intensity continuous and intermittent exercise in COVID-19 (ERS 2022) - "Individuals with ongoing symptomatic COVID-19 could safely undertake high intensity exercise performed continuously or intermittently."

Clinical • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Edited transcript of NERV earnings conference call or presentation 4-May-20 12:30pm GMT (Yahoo Finance) - "Research and development expenses were $8.1 million in the first quarter of 2020 compared to $11.6 million in the first quarter of 2019. The decrease in R&D expenses primarily reflects lower development expenses for the Phase III clinical trial of roluperidone and the Phase IIb clinical trial of MIN-117. R&D expenses are expected to decrease during 2020 with the completion of the Phase IIb trial of MIN-117 and the 12-week double-blind portion of the Phase III clinical trial of roluperidone."

Trial status • CNS Disorders • Depression

A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder (clinicaltrials.gov) - P2; N=360; Completed; Sponsor: Minerva Neurosciences; Recruiting ➔ Completed

Clinical • Trial completion

Minerva MDD treatment fails mid-stage trial, Company has no further development plans (BioSpace) - "Shares of Minerva Neurosciences are down more than 22% in premarket trading after the company announced late Wednesday that its Phase IIb major depressive disorder (MDD) trial failed to meet primary and key secondary endpoints."

P2b data • Stock price

Minerva Neurosciences Reports Topline Results From Phase 2b Trial of MIN-117 in Major Depressive Disorder (GlobeNewswire, Minerva Neurosciences, Inc) - "Minerva Neurosciences, Inc...announced today the Phase 2b trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints...At present, we have no plans for further clinical development of the molecule in MDD.'"

Discontinued • P2b data

Minerva Neurosciences Reports Third Quarter 2019 Financial Results and Business Updates (GlobeNewswire, Minerva Neurosciences, Inc) - "MIN-117. Enrollment has been completed in a Phase 2b trial of MIN-117 in the U.S. and Europe, with a total of 360 adult patients enrolled with moderate or severe major depressive disorder (MDD) with anxious distress and without psychotic features. The Company expects top-line results from this trial in the fourth quarter of 2019."

Enrollment status • P2b data

Minerva Neurosciences Announces Update for Three Clinical Trials (GlobeNewswire, Minerva Neurosciences, Inc) - "MIN-117: Patient screening has been completed in the Phase 2b trial of MIN-117 in moderate to severe major depressive disorder (MDD). Seltorexant (MDD2002 Phase 2 trial)...Mood improvement as measured by MADRS total score showed patients treated with seltorexant 20 mg dose experienced a greater improvement at week 24 (-22.7 points), compared to those treated with seltorexant 40 mg dose (-7.9 points), quetiapine 150 mg dose (-17.0 points) and quetiapine 300 mg dose (-14.8 points)."

Clinical • Clinical data • P2 data

Minerva Neurosciences Reports Second Quarter 2019 Financial Results and Business Updates (GlobeNewswire, Minerva Neurosciences, Inc) - "During the Second Quarter, Minerva announced several important clinical advancements, including positive top line results from two Phase 2b studies of seltorexant (MIN-202) in major depressive disorder (MDD) and insomnia. Patient enrollment progresses in pivotal Phase 3 trial of roluperidone (MIN-101) in schizophrenia, Phase 2 trial of seltorexant in MDD and Phase 2b trial of MIN-117 in MDD. Statistically significant and clinically meaningful improvement in symptoms of depression in MDD patients not responding adequately to first line anti-depressant therapies (MDD2001); Statistically significant and clinically meaningful improvement in symptoms of depression in MDD patients treated with seltorexant administered as monotherapy (MDD1009)...Primary and multiple secondary endpoints were also improved versus zolpidem (ISM2005)."

Clinical • Clinical data • Pipeline update

A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder (clinicaltrials.gov) - P2; N=324; Recruiting; Sponsor: Minerva Neurosciences; Trial completion date: Sep 2019 ➔ Dec 2019; Trial primary completion date: Apr 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

Minerva Neurosciences reports second quarter 2019 financial results and business updates (GlobeNewswire) - "Anticipated Clinical Milestones: Roluperidone: Phase 3 trial to treat negative symptoms in patients diagnosed with schizophrenia (monotherapy); completion of enrollment in this trial is expected during the second half of 2019, with top line results from the 12-week double blind phase of this trial expected in the fourth quarter of 2019. Seltorexant: Phase 2 positive-controlled MDD2002 trial to treat patients with MDD (adjunctive therapy); enrollment has been completed, with top-line results expected in the third quarter of 2019. MIN-117: Phase 2b trial to treat patients with MDD who also have symptoms of anxiety (monotherapy); completion of enrollment in this trial is expected in the third quarter of 2019, with top-line results expected in the fourth quarter of 2019."

Enrollment status • P2b data • P3 data: top line

Minerva Neurosciences Reports First Quarter 2019 Financial Results and Business Updates (GlobeNewswire, Minerva Neurosciences, Inc) - "A Phase 2b trial is ongoing with MIN-117 to treat patients diagnosed with MDD and associated anxiety disorders (Clinicaltrials.gov Identifier: NCT03446846). Approximately 324 patients are expected to be enrolled at 40 clinical sites in the U.S. and Europe. Completion of enrollment is now expected in the third quarter of 2019, with top-line results expected to be available in the fourth quarter of 2019."

Enrollment status • P2b data

Minerva Neurosciences reports fiscal 2018 fourth quarter and year end financial results and business updates (GlobeNewswire) - "Patients with MDD who also have symptoms of anxiety are being enrolled in a Phase 2b trial of MIN-117 (ClinicalTrials.gov Identifier: NCT03446846). A total of approximately 324 patients are expected to be enrolled at clinical sites in the U.S. and Europe. The Company expects top-line results in the first half of 2019."

P2b data