Corvus Pharmaceuticals shares plunge 5.36% on FDA review delays and mixed clinical updates

Corvus Pharmaceuticals Inc. shares plunged 5.3635% in pre-market trading on Dec. 17, 2025, signaling investor concerns amid mixed signals from its recent clinical pipeline updates and regulatory timelines.

The decline followed a regulatory filing indicating potential delays in the FDA's review of its Phase III trial data for a key oncology candidate, which had previously shown strong efficacy in mid-stage studies. Analysts noted the market's sensitivity to timing uncertainties, particularly as the company approaches critical data readouts in 2026.

Investor sentiment was further pressured by muted investor commentary in recent earnings calls, where management acknowledged higher-than-expected manufacturing costs for its lead asset. While the company reaffirmed its long-term growth strategy, short-term execution risks remain a focal point for institutional investors.

Market participants are now closely watching upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) conference, where Corvus is expected to share updated safety profiles and patient enrollment progress for its flagship program.

Until then, speculation persists over whether the firm can maintain its market valuation while navigating these operational and regulatory hurdles. Some hedge funds have reduced exposure, citing the imbalance between therapeutic potential and near-term cash burn, while others remain optimistic about the broader oncology market's demand for new therapies.

With a recent market cap of $2.8 billion and trailing 12-month revenue of $110 million, Corvus continues to rely heavily on preclinical and clinical milestones rather than revenue for its valuation narrative. The path forward appears to hinge on the company's ability to deliver clear, positive signals from its Phase III trials without additional financial strain.