- The FDA has designated Fast Track status to Celsion Corporation's CLSN GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy for advanced ovarian cancer.
- Fast Track status provides more frequent interaction with the FDA review team and a rolling review of the marketing application.
- GEN-1 is currently in Phase 2 OVATION study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with Stage 3/4 ovarian cancer.
- The study's primary endpoint is two show the equivalent of a 33% improvement in progression-free survival compared with the control arm (standard of care alone).
- Price Action: CLSN shares rally 74.7% at $3.32 in premarket trading on the last check Monday.
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