Celsion (NASDAQ:CLSN) stock was on the rise Monday after announcing fast-track approval from the U.S. Food and Drug Administration (FDA). This covers the treatment of advanced ovarian cancer from the company.
The fast-track status is for GEN-1. This is a DNA-mediated interleukin-12 (IL-12) immunotherapy designed to treat ovarian cancer. The company notes that this treatment is currently being tested in a Phase II clinical trial.
The fast-track designation comes after Celsion shared data from the Phase 1 study of combining GEN-1 with neoadjuvant chemotherapy with the FDA. That includes seven out of eight patients in the study seeing complete tumor resection. For comparison, just neoadjuvant chemotherapy alone had a 50% resection rate.
Michael Tardugno, chairman, president and CEO of Celsion, said this about the news boosting CLSN stock up today.
“Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design. In addition, should criteria be met, Fast Track-designated drugs are eligible for rolling review, a process whereby the drug’s sponsor can separately submit sections of its New Drug Application to the FDA.”
It’s worth pointing out that the FDA doesn’t hand out fast-track status lightly. The agency requires the treatment in development to show advantages over those currently on the market. CLSN’s promising early results are what warrant that designation.
CLSN stock was up 48.9% as of Monday morning and is up 253.6% since the start of the year.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.