In 2023, the BioWorld Neurological Diseases Index (BNDI) closed with a 4.36% increase, outperforming the Nasdaq Biotechnology Index (up 3.74%) but falling short of the surge seen in the Dow Jones Industrial Average (up 13.7%). The rebound marked a significant turnaround from November, when BNDI recorded an 18.37% year-to-date decline.
In the end, Minerva Neurosciences Inc. NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia.
The pivotal phase III study of brilaroxazine from Reviva Pharmaceuticals Holdings Inc. for adults with schizophrenia hit its primary endpoint and two key secondary endpoints, following positive phase II data in 2021. The serotonin-dopamine signaling modulator, the company’s lead candidate, is a once-daily treatment. Results from the study showed brilaroxazine demonstrated reductions in all major symptom domains for the patients and the secondary endpoints at week 4 when comparing the 50-mg dose with placebo.
Bolstered by new and positive open-label extension data, Minerva Neurosciences Inc. won’t let a failed phase III of roluperidone in treating schizophrenia get in the way of considering an NDA filing.
Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations.
A phase III test of roluperidone, a drug developed by Minerva Neurosciences Inc. with a goal of treating negative symptoms in schizophrenia, found that the experimental medicine failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function.
Minerva Neurosciences Inc. CEO Rémy Luthringer said his firm knew about the cyberattack on a contractor helping with the roluperidone phase III trial in schizophrenia "toward the end of the summer," when "the provider was trying to solve the problem" and ultimately did. But the attack still meant an enrollment delay, and Wall Street reacted accordingly. Despite imminent, possibly transforming data in major depressive disorder (MDD), investors pushed Minerva shares (NASDAQ:NERV) down $2.04, or 26.3%, Tuesday to close at $5.71.