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Stemline Therapeutics (STML) Gets One Step Closer to EMA Approval; Analyst Weighs in With U.S. Angle


Stemline Therapeutics (STML) announced the European Medicines Agency (EMA) is granting accelerated assessment for the company’s marketing authorization for oral treatment, Elzonris. The medication aims to manage symptoms of blastic plasmacytoid dendritic cell neoplasm (BPDCN), which is a form of cancer that manifests as lesions and is under the umbrella of leukemia. The cancer therapeutics company expects to have their Marketing Authorization Application completed in the first quarter of the year. The accelerated assessment can reduce the amount of time it will take from 210 days to 150, possibly putting it in a position to gain regulatory approval in Europe by the third quarter of 2019. It’s a win for the company and it’s intriguing for investors globally.

H.C. Wainwright’s analyst Raghuram Selvaraju is excited all the same. Standing bullish on the stock, he says he projects Stemline would launch Elzonris in the U.S. and start recognizing revenue in 2019. Due to this idea, the analyst rates the stock a Buy with a price target of $38, showing a big upside of 272%. (To watch Selvaraju’s track record, click here)

“Prior presentations showed that tagraxofusp monotherapy has demonstrated efficacy in an ongoing Phase 1/2 trial in patients with relapsed and refractory chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF). Tagraxofusp is directed to interleukin-3 receptor (CD123) in these indications. In our view, after the potential U.S. approval of tagraxofusp for first-line BPDCN treatment, data from potential pivotal trials in CMML and MF could provide label extension opportunities on top of BPDCN treatment. We believe a pivotal trial in CMML may be initiated in 2019,” Selvaraju said.

More updated clinical data in regard to CMML and MF are expected to be presented at the American Society of Hematology meeting in San Diego, California on December 1, which is in just a few days.

TipRanks reviewed all those who are interested in where Stemline is headed and all four analysts are bullish on the stock. The consensus price target stands at $30.33, showing a 197% upside from where the shares are currently selling. (See STML’s price targets and analyst ratings on TipRanks)