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Biotech Reports Positive Topline Data; Biologics License Application in Progress
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Ram Selvaraju, an analyst with H.C. Wainwright & Co., reviewed the recent clinical trial results released by this developer of cell therapies targeting oncology and orphan indications.

In a Nov. 1 research note from H.C. Wainwright & Co., analyst Ram Selvaraju reported that Stemline Therapeutics Inc. (STML:NASDAQ) "announced positive topline data from [its] pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN), which included results from stage 1 (lead-in, dose escalation), stage 2 (expansion) and stage 3 (pivotal, confirmatory)." BPDCN is an ultra-rare orphan indication for which no current treatment exists.

In view of the favorable results, H.C. Wainwright increased the "probability of success for SL-401 to 90% from 85%, and our estimated market value of the firm has increased to $975M from $857M," Selvaraju noted. "Therefore, we reiterate our Buy rating and are increasing our 12-month price target to $38 from $34 per share."

With regard to stage 3 of the trial, which consisted of 13 enrolled, first-line BPDCN patients, it "demonstrated a complete response rate of 54%," detailed Selvaraju. The overall response rate was 77%, with 46% of patients having "bridged to stem cell transplant following remission on SL-401." About 86% of complete responders remained relapse free at five to eight-plus months out.

With respect to all three stages combined, in which there were 45 BPDCN patients (32 first-line and 13 relapsed/refractory) enrolled, the complete response rate was 60%. The overall response rate was 82%, with 41% of first-line patients having transitioned to stem cell transplant following remission.

As for the safety profile of SL-401, Selvaraju wrote that it "has been consistent with prior observations and appears manageable."

The analyst concluded that the results "are within our expectations; from our perspective, they have sufficiently shown the efficacy of SL-401 in treating BPDCN to warrant a speedy approval." According to Stemline, it is "on track" to file a biologics license application (BLA) for approval of SL-401 in first-line BPDCN in Q4/17 or early Q1/18.

Subsequently, due to SL-401's breakthrough therapy designation and likely associated expedited review, this targeted therapy "could secure U.S. Food and Drug Administration approval in Q3/18, followed by a commercial launch in the U.S. in Q4/18," Selvaraju purported. In that quarter, Stemline could "start to recognize SL-401 revenue for the treatment of BPDCN."

In December, at the annual American Society of Hematology, the company is expected to detail the results from its BPDCN Phase 2 trial. It also will provide updates on its other studies of SL-401, individually or in combination, for indications such as acute myeloid leukemia and multiple myeloma.

H.C. Wainwright has a Buy rating and new $38 per share target price on Stemline, whose stock is currently trading at ~$13.30 per share.

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