After-Hours Gainers: Biotech And Med-Tech Surge On FDA Signals, Trial Visibility, Merger Tailwinds

(RTTNews) - A cluster of healthcare and med-tech stocks posted notable strength in Monday's after-hours session, driven by regulatory progress, clinical-data visibility, and merger-related developments, with a few quiet movers adding to the upside.

Organogenesis Holdings (ORGO) Jumps Over 11%

Organogenesis led the after-hours gainers after rising more than 11%. The company announced it has completed a planned Type-B meeting with the U.S. Food and Drug Administration, securing confirmation to begin a rolling Biologics License Application for ReNu before the end of December. The regulatory clarity appears to have fueled investor optimism around the company's late-stage pipeline momentum.

IO Biotech (IOBT) Edges Higher on Published Trial Data

Shares of IO Biotech gained more than 1% after hours following the publication of long-term clinical and immunological outcomes from its MM1636 Phase 1/2 trial in Nature Communications. The study evaluated IO102-IO103, an investigational peptide vaccine targeting tumor cells and immune-suppressive cells expressing IDO1 and/or PD-L1, in combination with PD-1 blockade for first-line metastatic melanoma. The visibility from a high-impact journal added incremental confidence to the company's immunotherapy platform.

STAAR Surgical (STAA) Climbs Over 4% on Revised ISS Recommendation

STAAR Surgical advanced more than 4% after hours after Institutional Shareholder Services issued a new report revising its stance on the company's pending merger with Alcon. ISS now recommends that all STAAR stockholders vote FOR the amended merger agreement at the company's December 19, 2025 special meeting. The shift in proxy advisory support appears to have boosted sentiment around the transaction's prospects.

ClearPoint Neuro (CLPT) Gains Over 9%

ClearPoint Neuro shares rose more than 9% despite no company-specific news. The move may reflect technical trading or increased interest in small-cap neurology-focused names.

EUDA Health (EUDA) Up Over 9%

EUDA Health also gained more than 9% in after-hours action. Similar to CLPT, the move came without any identifiable news, suggesting low-float dynamics or speculative trading interest.