Minerva (NERV) Shares Soar 29.82% on Schizophrenia Drug Pipeline Progress Driven by renewed investor optimism amid strategic developments in Roluperidone’s regulatory path, the stock hits a 2025 high.

Minerva (NERV) surged 29.82% on Tuesday, marking a three-day winning streak with cumulative gains of 34.76%. The stock hit an intraday high of $50.92, its highest level since October 2025, driven by renewed investor optimism amid strategic developments in its schizophrenia drug pipeline.

Regulatory progress for Roluperidone, Minerva’s investigational therapy, has historically been a key driver of volatility. The company’s May 2023 New Drug Application (NDA) submission to the FDA triggered a 25% premarket rally, reflecting confidence in the drug’s approval potential. However, the October 17, 2023, FDA refusal to file the NDA—citing application deficiencies—sparked a 58% single-day sell-off, underscoring the drug’s critical role in the company’s valuation. Recent gains suggest investors are reassessing the path forward, though regulatory hurdles remain a persistent risk.

A June 2023 $20 million private placement at a premium price of $2.00 per share temporarily bolstered liquidity and stabilized sentiment. The transaction, priced above market value at the time, was seen as a strategic move to fund Roluperidone’s development and reduce reliance on external financing. While this raised short-term confidence, the October FDA setback has reignited concerns about long-term cash flow and operational sustainability.

Minerva’s financials highlight its dependence on Roluperidone’s regulatory outcomes. Q1 2023 reports showed GAAP net losses of $1.31 per share and R&D expenses of $2.7 million, a reduction from $5 million in the prior year. The June capital raise aimed to address these constraints, but the FDA refusal has complicated future funding prospects. Analysts note the company’s high-risk profile, with stock price movements tightly linked to clinical and regulatory milestones rather than broader market trends.

Short interest data in October 2023 indicated rising pessimism following the FDA decision, while June’s private placement attracted temporary institutional support. Despite recent gains, the stock remains highly sensitive to developments in its schizophrenia drug candidate, with investors balancing the potential for breakthroughs against the risks of prolonged regulatory delays. The path to approval for Roluperidone will likely continue to dictate Minerva’s trajectory in the near term.