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Stemline Therapeutics (STML): Elzonris Approval Dawning on the Horizon, Says Analyst


Earlier this week, Stemline Therapeutics (STML) showcased clinical data of Elzonris (tagraxofusp) in blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) at the American Society of Hematology (ASH) 2018 meeting in San Diego, CA.

Recall, the FDA agreed to give Stemline’s cancer drug Elzonris a priority review in August, resulting in a PDUFA date of February 21, 2019. Elzonris is up for approval in first-line BPDCN patients.

H.C. Wainwright analyst Ram Selvaraju believes there are several important data points from the ASH presentation that are relevant to the upcoming regulatory decision. Selvaraju noted, “Elzonris (12 µg/kg/day) has shown; (1) a 90% (26/29) overall response rate (ORR); (2) 72% (21/29) complete response + clinical CR [CR with residual skin abnormality] (CR + CRc); and (3) 45% (13/29) of patients successfully bridged to stem cell transplant (SCT) in first-line patients with BPDCN. In relapsed or refractory patients with BPDCN, a 69% (9/13) ORR and 38% (5/13) CR + CRc + CRi were observed. Median overall survival (OS) was not yet reached in first-line patients, and median follow-up time is 23.0 months (range of 0.2-41+months).”

“Given these efficacy data for a rare cancer that currently lacks effective treatment, with average median overall survival of about a year on standard-of-care chemotherapy regimens, we believe Stemline should obtain approval of its Biologics License Application (BLA) on the PDUFA date,” the analyst concluded.

In the wake of this update, Selvaraju reiterates a Buy rating on STML stock, with a $38 price target, which represents a potential upside of 289% from where the stock is currently trading.

The rest of Wall Street echoes Selvaraju’s bullish play, as TipRanks analytics exhibit STML as a Strong Buy. Out of 6 analysts polled in the last 3 months, all 6 are bullish on Stemline stock. With a return potential of nearly 209%, the stock’s consensus target price stands at $30.80. (See STML’s price targets and analyst ratings on TipRanks)