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LYMPHIR (denileukin diftitox-cxdl) launched in the U.S. in December 2025 as the first new systemic therapy for cutaneous T-cell lymphoma since 2018, following FDA approval in August 2024. Mino-Lok completed a pivotal Phase 3 trial meeting primary and secondary endpoints. Halo-Lido completed Phase 2b; company is actively engaged with the FDA on next steps for both programs.
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