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Biotech Reports Positive Topline Data; Biologics License Application in Progress

Source: Streetwise Reports

 

November 7, 2017 (Investorideas.com Newswire) 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.

Disclosure:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following company mentioned in this article is a sponsor of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.

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