Minerva Neurosciences, Inc. 8-K

What Happened
Minerva Neurosciences (NERV) filed an 8-K reporting a Regulation FD disclosure and details from a virtual key opinion leader (KOL) event held Feb. 3, 2026. The company said, subject to ongoing FDA feedback, it expects to initiate enrollment (first patient screened) for a confirmatory Phase 3 trial of roluperidone in the second quarter of 2026. Presentation materials from the KOL event are posted on the company’s investor relations website.

Key Details

• Trial design: planned enrollment of 380 patients, randomized 1:1 to placebo or a double-blinded 64 mg daily dose of roluperidone.
• Primary endpoint: change from baseline in the PANSS Marder negative symptoms factor score (NSFS) at 12 weeks.
• Extension/relapse phase: after the initial 12-week treatment, patients enter a 40-week relapse assessment with crossover to daily 64 mg roluperidone or antipsychotics.
• Timing: topline efficacy results expected in H2 2027; relapse assessment data expected in H2 2028. Timelines are contingent on FDA feedback and other risks.

Why It Matters
This filing signals Minerva’s move to a confirmatory Phase 3 study for roluperidone targeting negative symptoms of schizophrenia — a key clinical and commercial milestone. For investors, the announced trial size, dose, endpoints, and expected data timelines (H2 2027 and H2 2028) provide concrete milestones to track. The company also cautioned that these are forward‑looking plans subject to regulatory feedback, trial risks, financing and other typical development uncertainties described in its SEC filings.