RLMD Soars 18.8% Pre-Market Ahead of Earnings Amid Strategic Shifts and FDA Momentum

Shares of Relmada Therapeutics (NASDAQ:RLMD) surged 18.845% in pre-market trading on November 13, 2025, signaling investor optimism ahead of the company's third-quarter earnings release scheduled for the same day.

The sharp pre-market rally appears linked to the company's recent strategic shifts. Relmada has pivoted toward product acquisitions to maximize shareholder value following the discontinuation of Phase 3 trials for REL-1017 in major depressive disorders. Current priorities include advancing its pipeline of NDV-01 and sepranolone, while maintaining resource efficiency. Recent FDA feedback has validated two separate study paths for NDV-01 in non-muscle invasive bladder cancer, adding momentum to its therapeutic development.

Analysts anticipate a challenging earnings report, with an estimated loss of $0.04 per share. Historical data reveals a pattern of underperformance, including a $0.28 EPS shortfall in Q2 2025 that triggered a 2.41% stock decline. However, long-term shareholders remain cautiously optimistic, as RLMD has gained 17.41% over the past 52 weeks despite intermittent volatility.

Backtest assumptions suggest a strategy focused on pre-earnings momentum could capture short-term volatility. Historical price reactions to guidance and FDA updates indicate that RLMD's stock is sensitive to clinical and regulatory developments, particularly in its NDV-01 program. Investors may monitor upcoming data from its clinical advisory board and Nasdaq compliance progress as potential catalysts.