Equillium Sets a 2026 Milestone Course: BLA Submission and New Oral Candidate on Deck

• Itolizumab: Planned submission of the Biologics License Application (BLA) in the first half of 2026.
• EQ504: Phase 1 study initiation targeted for mid-2026.
• Financial calendar: Full-year 2025 results to be released on March 26, 2026.

Itolizumab’s regulatory path in focus
The forthcoming months are largely driven by the regulatory timetable for Itolizumab. Based on the prior clinical data in acute graft-versus-host disease (aGVHD), Equillium is preparing a BLA filing. The company aims to submit during the first half of 2026. A successful application would clear the way for commercialization and shift the business from a development-focused model to product sales.

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Expansion of the clinical pipeline
Simultaneously, Equillium is broadening its therapeutic portfolio with EQ504, an oral AhR modulator. The transition to an oral formulation is tied to the planned Phase 1 start in mid-2026. Aligning with a broader industry trend toward oral autoimmune therapies, the upcoming study will test whether the clinical validation of the AhR-modulation platform meets expectations. This pipeline expansion could potentially lessen reliance on a single asset.

Financial stability and cash runway
A key milestone for assessing financial resilience lies on March 26, 2026, when Equillium will publish its full-year 2025 results. Investors will be looking for details on cash runway and how funding will support the upcoming clinical programs. In this phase, liquidity duration is as important as clinical data, given that late-stage trials and regulatory processes require substantial resources. The market will scrutinize R&D spend relative to achieved milestones to gauge the company’s long-term financial health.