Clinical trial milestones advancing toward registration and approval

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Several biotech companies reported meaningful clinical progress toward regulatory submissions, including IMNM's FDA acceptance of the varegacestat NDA with a PDUFA date in April 2027, AQST's completed human factors and pharmacodynamic studies supporting Anaphylm NDA resubmission in Q3 2026, and IMUX's specific NDA submission timeline targeting mid-2027 for progressive MS. These advances represent the maturation of pipelines from early-stage to registrational-stage programs.

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