HC Wainwright Initiates Stemline Therapeutics At Buy

In a report published Monday, H.C. Wainwright analysts initiated coverage of

Stemline Therapeutics Inc

with a Buy rating and a price target of $38. Stemline Therapeutics is an emerging player in the biotechnology filed and is focusing on the development of novel anti-cancer therapeutics that eradicate both the tumor bulk and the cancer stem cells. "In our view, Stemline represents a unique investment opportunity in the small-cap oncology space due to its rapidly advancing clinical-stage pipeline and the proprietary development platform in cancer stem cells (CSCs).Accelerated approval pathway," the analysts stated. The company's lead drug candidate, SL-401, is risk-mitigated from a clinical as well as regulatory perspective. "Considering the orphan drug designation from the FDA, and the survival-enhancing efficacy demonstrated in clinical trials thus far, we believe SL-401 is likely to produce positive results in 2015 from the ongoing Phase 2 lead-in study in BPDCN. We think SL-401 could secure approval on the basis of a single, randomized, open-label pivotal study enrolling 40-45 BPDCN patients, which is scheduled to initiate in 2H 2015," the analysts added. Stemline's second candidate SL-701, an immunotherapy with orphan drug designation for brain cancer, has previously demonstrated anti- tumor efficacy in both adult and pediatric patients. "We believe this drug could report initial data from the ongoing Phase 2 second-line adult GBM study in 2015, and may be eligible for accelerated approval," the report stated. Apart from the company's focus on cancer stem cells, several major near-term catalysts for the company include the announcement of data from its ongoing BPDCN led-in-study in 2015 and the initiation of a pivotal trial for BPDCN by end-2015. "Stemline is one of the most attractive development-stage oncology-focused firms, given its potential for an accelerated path to market for niche indications, and its technology and pipeline targeting CSCs," the analysts wrote.