Stemline Therapeutics Inc (NASDAQ:STML) announced earlier this week that it had submitted a marketing authorization application (MAA) with the European Medicines Agency (EMA) for ELZONRIS.
Stemline Therapeutics filed the MAA with the EMA to secure ELZONRIS approval for treating plasmacytoid dendritic cell neoplasm (BPDCN) patients. The European regulatory watchdog gave ELZONRIS’s MAA an accelerated assessment in November last year. The U.S Food and Drug Administration (FDA) approved ELZONRIS as a BPDCN in December 2018. The drug was approved for treating both adult and pediatric patients above two years old. Additionally,
The FDA approved the treatment for patients who had received previous treatment as well as those that have never been treated before. ELZONRIS is the first BPDCN treatment to receive approval and also the first CD123-targeted therapy to receive approval.
“The submission of the ELZONRIS MAA is another major step forward for providing this important targeted treatment to patients, globally,” pointed out Stemline Therapeutics CEO, Ivan Bergstein.
The CEO also stated that his company would collaborate with the EMA to make sure that patients can access the treatment as fast as possible. Bergstein also noted that Stemline’s commercial team would continue pushing towards more awareness of BPDCN as well as CD123 testing on a global scale. A European approval would allow the company to reach more patients who can benefit from the treatment.
Stemline stock closed the latest trading session on Thursday at $10.02 after tanking by -3.19% from the stock value during the previous close. Its current 52-week high is 20.55 while its 52-week low is $7.82.
Stemline has earned itself a “buy” consensus rating from nine analysts that have the company’s stock on their watch lists. Seven out of the nine analysts gave a “buy” rating while only one analyst issued a “hold” and the other one issued a “sell” rating. They have also set this year’s average 1-year price target at $24.45.
Stemline announced its latest quarterly earnings results in November 2018 revealing that it achieved a $0.73 earnings per share (EPS) for the quarter. The reported EPS was slightly higher than the estimated $0.67.