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Stemline Therapeutics Inc (STML.OQ)

STML.OQ on NASDAQ Stock Exchange Capital Market

12.37USD
22 Mar 2019
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Latest Key Developments (Source: Significant Developments)

Stemline Therapeutics Files For Mixed Shelf Offering Of Up To $250 Million - SEC Filing
Friday, 15 Mar 2019 05:15pm EDT 

March 15 (Reuters) - Stemline Therapeutics Inc ::STEMLINE THERAPEUTICS FILES FOR MIXED SHELF OFFERING OF UP TO $250 MILLION - SEC FILING.  Full Article

Stemline Therapeutics Announces Proposed Public Offering Of Common Stock
Monday, 14 Jan 2019 04:34pm EST 

Jan 14 (Reuters) - Stemline Therapeutics Inc ::STEMLINE THERAPEUTICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK.STEMLINE THERAPEUTICS - INTENDS TO OFFER AND SELL, SUBJECT TO MARKET CONDITIONS, 6.6 MILLION SHARES OF ITS COMMON STOCK IN UNDERWRITTEN PUBLIC OFFERING.  Full Article

Stemline Therapeutics Announces Submission Of European Marketing Authorization Application For ELZONRIS
Monday, 7 Jan 2019 09:50am EST 

Jan 7 (Reuters) - Stemline Therapeutics Inc ::STEMLINE THERAPEUTICS ANNOUNCES SUBMISSION OF EUROPEAN MARKETING AUTHORIZATION APPLICATION (MAA) FOR ELZONRIS™.STEMLINE THERAPEUTICS INC - MAA SEEKS APPROVAL FOR TREATING PATIENTS WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN).  Full Article

Stemline Therapeutics Wins FDA Approval For Elzonris - FDA Website
Friday, 21 Dec 2018 10:43am EST 

Dec 21 (Reuters) - U.S. Food and Drug Administration::STEMLINE THERAPEUTICS WINS FDA APPROVAL FOR ELZONRIS - FDA WEBSITE.  Full Article

FDA Approves Elzonris Infusion For Treatment Of BPDCN
Friday, 21 Dec 2018 10:23am EST 

Dec 21 (Reuters) - U.S. Food and Drug Administration::FDA APPROVES FIRST TREATMENT FOR RARE BLOOD DISEASE.U.S. FDA - APPROVED ELZONRIS INFUSION FOR TREATMENT OF BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM IN ADULTS AND IN PEDIATRIC PATIENTS.U.S. FOOD AND DRUG ADMINISTRATION - LABELING FOR ELZONRIS CONTAINS A BOXED WARNING.U.S. FDA - ELZONRIS BOXED WARNING TO ALERT ABOUT INCREASED RISK OF CAPILLARY LEAK SYNDROME WHICH MAY BE LIFE-THREATENING/FATAL TO PATIENTS IN TREATMENT.  Full Article

Stemline Therapeutics Announces That EMA Grants Accelerated Assessment For Planned Elzonris MAA
Tuesday, 20 Nov 2018 07:03am EST 

Nov 20 (Reuters) - Stemline Therapeutics Inc ::STEMLINE THERAPEUTICS ANNOUNCES THAT EUROPEAN MEDICINES AGENCY (EMA) GRANTS ACCELERATED ASSESSMENT FOR PLANNED ELZONRIS MARKETING AUTHORIZATION APPLICATION (MAA).STEMLINE THERAPEUTICS - EMA GRANTED ACCELERATED ASSESSMENT FOR UPCOMING CENTRALIZED MAA, WHICH STEMLINE EXPECTS TO COMPLETE IN Q1 2019.STEMLINE THERAPEUTICS -BLA FOR ELZONRIS IN BPDCN RECEIVED PRIORITY REVIEW STATUS FROM U.S. FDA, WITH TARGET ACTION DATE OF FEB 21, 2019, UNDER PDUFA.  Full Article

Stemline Therapeutics Announces That FDA Accepts Elzonris Biologics License Application
Monday, 13 Aug 2018 06:30am EDT 

Aug 13 (Reuters) - Stemline Therapeutics Inc ::STEMLINE THERAPEUTICS ANNOUNCES THAT FDA ACCEPTS ELZONRIS™ BIOLOGICS LICENSE APPLICATION (BLA) AND GRANTS PRIORITY REVIEW.STEMLINE THERAPEUTICS INC - FDA ALSO GRANTED PRIORITY REVIEW FOR BLA AND HAS SET A TARGET ACTION DATE OF FEBRUARY 21, 2019, UNDER PDUFA.  Full Article

Stemline Therapeutics reports Q3 loss per share $0.68
Thursday, 9 Nov 2017 04:01pm EST 

Nov 9 (Reuters) - Stemline Therapeutics Inc :Stemline Therapeutics reports third quarter 2017 financial results.Q3 loss per share $0.68.Q3 earnings per share view $-0.59 -- Thomson Reuters I/B/E/S.Stemline Therapeutics-‍stemline ended Q3 of 2017 with $79.9 million in cash, cash equivalents and investments, as compared to $93.2 million as of June 30, 2017​.  Full Article

Stemline Therapeutics Inc - ‍phase 2 trial of SL-401 has met its primary endpoint​
Tuesday, 31 Oct 2017 07:00am EDT 

Oct 31 (Reuters) - Stemline Therapeutics Inc :Stemline Therapeutics Inc - ‍phase 2 trial of SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm has met its primary endpoint​.Stemline Therapeutics Inc - ‍based on feedback from U.S. FDA, co remains on track to begin submission of BLA in 4Q17-1Q18 timeframe for SL-401​.  Full Article

U.S. FDA approves Stemline Therapeutics' rare blood disease treatment

The U.S. Food and Drug Administration on Friday approved Stemline Therapeutics Inc's Elzonris for the treatment of a rare blood disease in adults and children aged two years and above.