Stemline's Elzonris Launch On Schedule, HC Wainwright Says In Bullish Initiation

Stemline Therapeutics Inc STML has received FDA approved for Elzonris ahead of the Feb. 21 PDUFA date. The approval coming in two months early highlights “the urgent need” in the indication, according to H.C. Wainwright.

The Analyst

Analyst Raghuram Selvaraju initiated coverage of Stemline Therapeutics with a Buy rating and $38 price target.

The Thesis

The FDA has approved Elzonris infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm, or BPDCN, in adults and in pediatric patients 2 and up, Selvaraju said in the Wednesday initiation note. 

Not only does this represent the first therapy to be approved for BPDCN, it has been approved for treatment-naïve — first-line — patients as well as relapsed or refractory patients who have received intensive chemotherapy, the analyst said. 

It is unlikely that the boxed warning on Elzonris’ prescription label regarding the increased risk of capillary leak syndrome will deter physicians from prescribing BPDCN patients with the drug, since CLS is largely cycle 1-related and manageable with monitoring and pre-emptive measures, as mentioned at the American Society of Hematology 2018 meeting, Selvaraju said.

With Stemline indicating that the planned launch of Elzonris in early 2019 is on track, the probability of success has increased from 90 percent to 100 percent, the analyst said. 

H.C Wainwright increased its annual price estimate for Elzonris from $350,000 to $400,000. 

Price Action

Stemline Therapeutics were trading higher by 5.91 percent at $8.78 at the time of publication Wednesday. 

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