Stemline Therapeutics (STML)

[cashcow3]

HUGE NEWS

Completes Stage 3 Enrollment
Stemline has completed enrollment of the Stage 3 cohort of the SL-401 pivotal trial in BPDCN. Stage 3 enrolled 13 first-line BPDCN patients; statistical analysis will be based on evaluable first-line patients. The registration pathway was previously agreed upon with the U.S. Food and Drug Administration (FDA). Depending on the data from the trial, Stemline plans to use the results generated to support the potential filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, and is targeting possible BLA filing in the second half of this year.