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Stemline Therapeutics (STML) receives Breakthrough Therapy Designation from U.S. FDA for SL-401

August 23, 2016 8:42am

STML closed FLAT at $7.40 and is UP in the ppre-open +$1.99 or +26.89% - BUY

The U.S. FDA has granted Breakthrough Therapy Designation to SL-401, a targeted therapy directed to the interleukin-3 receptor (CD123), for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require clinical evidence demonstrating the drug may offer substantial improvement on one or more clinically significant endpoints versus existing therapies.

The Bottom Line: This Breakthrough Designation request was supported by efficacy and safety data from the P2 trial evaluating SL-401 in BPDCN patients in both the first-line and relapsed/refractory settings. Given SL-401’s clinical activity in this CD123+ cancer, coupled with its manageable, non-overlapping safety profile with other oncology agents, STML’s drug’s prospects are elevated in enrolling clinical trials in additional CD123+ indications as both a single agent and in combination.

STML closed FLAT at $7.40 and is UP +$1.99 or +26.89%

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