AbbVie's Stock Dives 1.49% as EPKINLY's FDA Approval Fails to Lift Volume to 125th in Dollar Ranking

Market Snapshot

On November 20, 2025, , marking a reversal from recent gains. , ranking 125th in dollar volume among U.S.-listed stocks. The drop in volume suggests reduced investor participation despite the company’s announcement of a major FDA approval for its drug EPKINLY. The stock’s performance contrasts with the broader market’s positive momentum, highlighting mixed sentiment around the approval’s immediate financial implications.

Key Drivers

FDA Approval of EPKINLY as a Milestone in Lymphoma Treatment

The U.S. Food and Drug Administration (FDA) approved EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) for treating relapsed or refractory follicular lymphoma (FL). This marks the first bispecific antibody combination therapy approved for the condition and expands EPKINLY’s third indication. The approval is based on the Phase 3 EPCORE FL-1 trial, . , the therapy is positioned as a chemotherapy-free, outpatient-friendly option, potentially reshaping FL treatment paradigms.

Clinical Trial Results and Market Differentiation

The EPCORE FL-1 trial results underscore EPKINLY’s efficacy, with progression-free survival (PFS) hazard ratios favoring the combination therapy. . These outcomes strengthen EPKINLY’s competitive edge in a market where existing therapies for FL are considered suboptimal. Experts, including Dr. of Memorial Sloan Kettering Cancer Center, emphasized the regimen’s durability and potential to become a new standard of care. However, the approval comes with boxed warnings for cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), which may temper adoption due to safety concerns.

Strategic Collaboration and Revenue Implications

The approval reflects a strategic collaboration between AbbVie and Genmab, with the two companies co-developing and commercializing EPKINLY in the U.S. and Japan. AbbVie’s role in global commercialization highlights its commitment to expanding its oncology portfolio, a sector critical for offsetting declines in its immunology and dermatology segments. In Q3 2025, , , signaling growing market traction. The expanded indication is expected to drive further revenue growth, though analysts note potential challenges from pricing pressures and reimbursement constraints in key markets.

Mixed Financial Metrics and Market Sentiment

Despite the regulatory milestone, AbbVie’s financial health remains a concern. , with declining operating and net margins. , near a 10-year high, reflects elevated valuations, raising questions about long-term sustainability. While the approval of EPKINLY + R2 could bolster near-term earnings, investors remain cautious about AbbVie’s ability to maintain profitability amid rising R&D costs and patent expirations for key products like Humira. The stock’s decline on the day of the announcement may reflect skepticism about translating clinical success into robust financial performance.

Broader Industry Context and Future Outlook

The approval aligns with the pharmaceutical industry’s shift toward bispecific antibodies as a next-generation oncology therapy. EPKINLY’s success in FL could catalyze expansion into other B-cell malignancies, a market Genmab and AbbVie are actively targeting. However, the therapy’s adoption will depend on real-world evidence of safety and efficacy, as well as payer and physician acceptance. , the expanded indication positions EPKINLY to capture a significant share of a market currently lacking curative options. Long-term success will hinge on AbbVie’s ability to balance innovation with cost-effectiveness in an increasingly competitive and price-sensitive healthcare landscape.