Thinly traded nano cap Novan (NASDAQ:NOVN) is poised for a significant down move after announcing failed results from two Phase 3 clinical trials, B-SIMPLE1 and B-SIMPLE2, evaluating topical gel SB206 for the treatment of molluscum contagiosum (MC).
Both failed to achieve the primary endpoint of complete clearance of all treatable MC at week 12. Compete results, including 24-week safety data, should be available in March.
Undeterred, the company says multiple sensitivity analyses support a path forward. It plans to use the results from B-SIMPLE2 and an additional confirmatory study, expected to start in April, as the principal data package for a U.S. marketing application targeted for Q2 2021, subject to funding and FDA feedback.
Management will host a conference call tomorrow, January 3, at 8:30 am ET to discuss the results.
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