11.55 0.00 (0.03%)
After hours: 4:11PM EST
|Bid||7.50 x 4000|
|Ask||19.00 x 1400|
|Day's Range||11.45 - 11.66|
|52 Week Range||7.82 - 20.55|
|Beta (3Y Monthly)||0.85|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 14, 2019 - Mar 18, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||28.50|
Want to participate in a short research study? Help shape the future of investing tools and receive a $20 prize! Ivan Bergstein became the CEO of Stemline Therapeutics, Inc. (NASDAQ:STML)Read More...
Stemline Therapeutics, Inc. (STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, today announced that the European Medicines Agency (EMA) has completed its validation of the Marketing Authorization Application (MAA) for ELZONRIS™ (tagraxofusp-erzs). Stemline submitted the MAA earlier this month seeking approval of ELZONRIS for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure.
NEW YORK, Jan. 24, 2019 -- In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors,.
We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. The flip side of that is that there are more Read More...
Stemline Therapeutics, Inc. (STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, today announced the closing of a previously announced underwritten public offering of 10,222,222 shares of its common stock, which included the exercise in full of the option to purchase 1,333,333 additional shares, at a price of $9.00 per share. J.P. Morgan Securities LLC and Cowen and Company, LLC acted as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC acted as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. acted as co-managers for the offering.
Stemline Therapeutics, Inc. (STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, today announced the pricing of an underwritten public offering of 8,888,889 shares of its common stock at a price of $9.00 per share, with expected gross proceeds to Stemline of $80 million. Stemline has also granted the underwriters a 30-day option to purchase up to 1,333,333 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. are acting as co-managers for the offering.
Stemline Therapeutics, Inc. (STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, today announced that it intends to offer and sell, subject to market conditions, 6,600,000 shares of its common stock in an underwritten public offering. In addition, Stemline intends to grant the underwriters a 30-day option to purchase up to an additional 990,000 shares of its common stock offered in the public offering. J.P. Morgan Securities LLC is acting as book-running manager for the offering.
Stemline Therapeutics, Inc. (STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that it has submitted the marketing authorization application (MAA) for ELZONRIS (tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment.
Stemline Therapeutics, Inc. (STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that Ivan Bergstein, M.D., Stemline’s CEO, will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 5:00 PM PT at the Westin St. Francis Hotel in San Francisco, CA. ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the upcoming marketing authorization application (MAA), which is expected to be submitted in the first quarter of 2019.
Stemline Therapeutics Inc (NASDAQ: STML ) has received FDA approved for Elzonris ahead of the Feb. 21 PDUFA date. The approval coming in two months early highlights “the urgent need” in the indication, ...
Stemline Therapeutics, Inc. (NASDAQ:STML) is a stock with outstanding fundamental characteristics. When we build an investment case, we need to look at the stock with a holistic perspective. In the Read More...
- ELZONRIS is approved to treat adult and pediatric patients with both treatment-naïve and previously-treated BPDCN - Conference call scheduled for Friday, December 21, 2018 at 4:30 PM ET: Toll Free: (888) ...
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. This is the first approved treatment for the condition, blastic plasmacytoid dendritic cell neoplasm (BPDCN), Richard Pazdur, director of the FDA's Oncology Center of Excellence, said. The labeling for Elzonris contains a boxed warning, FDA's harshest, flagging increased risk of capillary leak syndrome, which may be life-threatening or fatal to patients in treatment.
CORAL GABLES, FL / ACCESSWIRE / December 21, 2018 / The biotech industry is based on a framework made up of cunning edge medical technologies designed with the patient's best interests at heart. Premier Health Group (OTC:PHGRF) (CSE:PHGI), Proteostasis Therapeutics, Inc (PTI), Alta Mesa Resources, Inc (AMR), and Stemline Therapeutics, Inc (STML) are 4 biotech stocks worth taking a look at. Premier Health Group (OTC:PHGRF) (CSE:PHGI), as a company, recognizes the importance of meeting the demands and needs of its 100,000, and growing, active patient network.
Earlier this week, Stemline Therapeutics (STML) showcased clinical data of Elzonris (tagraxofusp) in blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) at the American Society of Hematology (ASH) 2018 meeting in San Diego, CA.Recall, the FDA agreed to give Stemline's cancer drug Elzonris a priority review in August, resulting in a PDUFA date of February 21, 2019. Elzonris is up for approval in first-line BPDCN patients.H.C. Wainwright analyst Ram Selvaraju believes there are several important data points from the ASH presentation that are relevant to the upcoming regulatory decision. Selvaraju noted, "Elzonris (12 µg/kg/day) has shown; (1) a 90% (26/29) overall response rate (ORR); (2) 72% (21/29) complete response + clinical CR [CR with residual skin abnormality] (CR + CRc); and (3) 45% (13/29) of patients successfully bridged to stem cell transplant (SCT) in first-line patients with BPDCN. In relapsed or refractory patients with BPDCN, a 69% (9/13) ORR and 38% (5/13) CR + CRc + CRi were observed. Median overall survival (OS) was not yet reached in first-line patients, and median follow-up time is 23.0 months (range of 0.2-41+months).""Given these efficacy data for a rare cancer that currently lacks effective treatment, with average median overall survival of about a year on standard-of-care chemotherapy regimens, we believe Stemline should obtain approval of its Biologics License Application (BLA) on the PDUFA date," the analyst concluded.In the wake of this update, Selvaraju reiterates a Buy rating on STML stock, with a $38 price target, which represents a potential upside of 289% from where the stock is currently trading.The rest of Wall Street echoes Selvaraju's bullish play, as TipRanks analytics exhibit STML as a Strong Buy. Out of 6 analysts polled in the last 3 months, all 6 are bullish on Stemline stock. With a return potential of nearly 209%, the stock’s consensus target price stands at $30.80. (See STML's price targets and analyst ratings on TipRanks) More recent articles about STML: * 3 Biotech Stocks That Could Explode Higher in 2019 * Stemline Therapeutics (STML) Gets One Step Closer to EMA Approval; Analyst Weighs in With U.S. Angle * Cowen Puts Stemline Therapeutics Inc's (STML) Stock Collapse Into Perspective * Roth Capital Reiterates Buy On Stemline Following 3Q14 Results
Black Friday is past. So is Cyber Monday. But it's not too late to buy one of the best Christmas gifts of all -- biotech stocks. Analysts think there are three biotech stocks, in particular, that look like good picks right now: Stemline Therapeutics (STML), Global Blood Therapeutics (GBT), and Sesen Bio (SESN). Let's take a closer look.Stemline: Analysts See 200% Gains Ahead of Upcoming FDA DecisionStemline filed a biologics license application (BLA) for its lead drug candidate, ELZONRIS (SL-401), which in October 2017 reported promising phase 2 data as a first-line treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN). The application has received priority review from the FDA and has a PDUFA date scheduled for February 21, 2019, which is when regulators will decide the drug's commercial fate. ELZONRIS has also been granted Breakthrough Therapy Designation and Orphan Drug Designation by the FDA."Given the strength of the pivotal study data combined with the significant unmet clinical need for BPDCN patients, we believe there is a strong likelihood of approval by the PDUFA date," Ladenburg analyst Matthew Kaplan opined. "We believe SL-401 could generate >$130 million U.S. revenues in the BPDCN indication at peak. We are encouraged by the progress of STML’s commercial preparations and look forward to updates as we move closer to the PDUFA date."Kaplan rates STML shares a Buy with a price target of $41, which implies a potential upside of nearly 300% from current levels.Wedbush's top analyst David Nierengarten added, "With stock trading near the lower end of its YTD range we would recommend investors accumulate shares going into what is likely to be a straightforward approval process for SL-401. With Breakthrough Status and BLA submitted we believe -401 is poised to be approved in early 2019, and we have confidence that STML can make a successful transition into a commercial company given small size of BPDCN market. With an EV of just about $400M, which is also what we approximate peak SL-401 sales at, we see STML as an attractive and easily digestible takeover target." (To watch Nierengarten's track record, click here)Bottom line: When it comes to Wall Street’s bet, the odds are on this biotech stock, with TipRanks analytics showcasing STML as a Strong Buy. With an average price target of $30.80, analysts are predicting massive upside potential of about 200% for the stock. In total, Stemline stock has received 6 'buy' ratings in the last three months.Global Blood: Clear Shot at Accelerated ApprovalMonday, Global Blood provided positive regulatory update on potential accelerated approval for Voxelotor in sickle cell disease (SCD) after consulting with the FDA. The company plans to have a pre-NDA FDA meeting in Q1:19 and possibly start submitting regulatory filings with a NDA in H2 2019.In reaction, Wedbush analyst Liana Moussatos boosted her price target on GBT stock to $93 (from $73), while reiterating an Outperform rating.Moussatos commented, "We remain comfortable with our August 2020 U.S. launch timing, $40.1 million 2020 sales estimate and achieving more than $1 billion in 2023. Although GBT stock greatly appreciated on December 3rd with this news, it should not be a surprise after positive comments from key opinion leaders (KOLs) participating in the FDA-ASH SCD Clinical Endpoints Workshop (October 17-18, 2018; Rockville, MD) were supportive of elevated hemoglobin in SCD (to treat hemolysis) as a primary endpoint for accelerated approval. Due to anticipated reduced regulatory and clinical risk and positive expanded HOPE Part A and HOPE-KIDS 1 results presented at ASH, we are increasing our multiple to 7x for positive Phase 3 results and raising our PT to $93 from $73. With GBT closing at $46.62 on December 3 after the news was released, we consider the stock to be undervalued in front of potentially major regulatory catalysts in 2019-2020. The Company ended Q3 with about $482.1 million in cash and we project runway into 2021 or longer depending on potential sales."Moussatos is not the only fan of the biotech company on Wall Street, as TipRanks analytics exhibit GBT as a Strong Buy. Based on 11 analysts polled in the last 3 months, 10 rate a Buy rating on Global Blood stock while only 1 recommends Hold. The 12-month average price target stands at $90.78, marking a 95% upside from where the stock is currently trading.Sesen: All Eyes on 6-Month Data Readout from VISTASesen is on-track to report updated six-month results from the ongoing Phase 3 VISTA study of Vicinium for the treatment of NMIBC in December. Recall, VISTA is a 134-patient, single-arm study with co-primary endpoints of complete response rate at 12 months and duration of response (DOR), and secondary endpoints of event-free survival, progression-free survival, overall survival, and time to cystectomy. The company previously published the initial 3-month readout back in May (39% CR rate), which was robust and within expectations.H.C. Wainwright's Swayampakula Ramakanth has weighed in with his two cents: "Based on the dinner discussions [with KOL], we believe that depending on the final VISTA results, Vicinium could have a compelling case for FDA approval. The more important factors in Vicinium’s favor are the current high unmet need for BCGunresponsive NMIBC and the drug’s excellent safety profile; with virtually no bladder-saving therapies available, a safe, proven treatment like Vicinium could enjoy a first-mover advantage with both the agency and with clinicians. In our view, Vicinium would very likely be approved should the drug achieve a 12-month complete response rate of >20% in VISTA, and should not be ruled out either if it only manages to repeat the previous 16% response rate achieved in Phase 2. Therefore, with regards to the upcoming six-month results, we believe that a response rate of >30% would be a strong positive for Sesen, while a rate on par with the 27% achieved in Phase 2 would still be on track for positive 12-month results."Ramakanth rates SESN stock a Buy with 12-month price target of $3.00, which implies a potential upside of nearly 87% upside from current levels.We can see from TipRanks that SESN has received 4 'buy ratings' in the past 12 months. Based on these ratings, the average $5.00 price target on the stock translates into upside of over 200% from the current share price. (See SESN's price targets and analyst ratings on TipRanks) More recent articles about GBT: * Sesen (SESN) Stock Just Lost a Bull * Stemline Therapeutics (STML): Elzonris Approval Dawning on the Horizon, Says Analyst * Global Blood Therapeutics (GBT) Gets Attention of FDA As Well As Investors * What Makes This Analyst Bullish About Bladder Cancer Treatment? Sesen Biopharma (SESN) Stock Could Be On the Rise
NEW YORK, Dec. 06, 2018 -- Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology.
NEW YORK, Nov. 30, 2018 -- Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology.
NEW YORK, Nov. 27, 2018 -- In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors,.
Every investor in Stemline Therapeutics Inc (NASDAQ:STML) should be aware of the most powerful shareholder groups. Institutions often own shares in more established companies, while it’s not unusual to see Read More...
The New York-based company said it had a loss of 73 cents per share. The results fell short of Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was ...