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Wednesday, May 20, 2015

Stemline Therapeutics: SL-401 (母细胞性浆细胞样树突细胞肿瘤治療)& SL-701(腦瘤疫苗)

Stemline Therapeutics Stock Price Down 4.9% Following Weak Earnings (STML) May 11th, 2015 - 0 comments - Filed Under - by Thomas Shares of Stemline Therapeutics (NASDAQ:STML) were down 4.9% during mid-day trading on Monday after the company announced weaker than expected quarterly earnings, Analyst RN reports. The company traded as low as $13.55 and last traded at $13.62, with a volume of 57,400 shares. The stock had previously closed at $14.32.The company reported ($0.46) earnings per share for the quarter, missing the analysts' consensus estimate of ($0.45) by $0.01.A number of analysts have recently weighed in on STML shares. Analysts at HC Wainright initiated coverage on shares of Stemline Therapeutics in a research note on Monday, April 27th. They set a "buy" rating and a $38.00 price target on the stock. Analysts at Jefferies Group initiated coverage on shares of Stemline Therapeutics in a research note on Wednesday, April 22nd. They set a "buy" rating and a $30.00 price target on the stock. Finally, analysts at Wedbush set a $35.00 price target on shares of Stemline Therapeutics and gave the company a "buy" rating in a research note on Tuesday, March 17th. One equities research analyst has rated the stock with a hold rating and five have given a buy rating to the company. Stemline Therapeutics presently has a consensus rating of "Buy" and an average price target of $34.06.In other Stemline Therapeutics news, insider Eric K. Rowinsky sold 10,824 shares of the company's stock on the open market in a transaction that occurred on Monday, April 27th. The stock was sold at an average price of $15.77, for a total value of $170,694.48. The transaction was disclosed in a document filed with the SEC, which is available at this link.The stock's 50-day moving average is $15. and its 200-day moving average is $15.. The company's market cap is $176.94 million. Stemline Therapeutics, Inc is a clinical-stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (NASDAQ:STML) and tumor bulk. The Company is developing two clinical-stage product candidates, SL-401 and SL-701.

Activity of SL-401, a targeted therapy directed to interleukin-3 receptor, in blastic plasmacytoid dendritic cell neoplasm patients This is the first prospective study of treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic malignancy derived from plasmacytoid dendritic cells that typically involves the skin and rapidly progresses to a leukemia phase. Despite being initially responsive to intensive combination chemotherapy, most patients relapse and succumb to their disease. Because BPDCN blasts overexpress the interleukin-3 receptor (IL3R), the activity of SL-401, diptheria toxin (DT)388IL3 composed of the catalytic and translocation domains of DT fused to IL3, was evaluated in BPDCN patients in a phase 1-2 study. Eleven patients were treated with a single course of SL-401 at 12.5 μg/kg intravenously over 15 minutes daily for up to 5 doses; 3 patients who had initial responses to SL-401 received a second course in relapse. The most common adverse events including fever, chills, hypotension, edema, hypoalbuminemia, thrombocytopenia, and transaminasemia were transient. Seven of 9 evaluable (78%) BPDCN patients had major responses including 5 complete responses and 2 partial responses after a single course of SL-401. The median duration of responses was 5 months (range, 1-20+ months). Further studies of SL-401 in BPDCN including those involving multiple sequential courses, alternate schedules, and combinations with other therapeutics are warranted. This trial is registered at clinicaltrials.gov as #NCT00397579.

Stemline Therapeutics Announces FDA Acceptance of IND for SL-701, a Synthetic Multi-Peptide Vaccine Targeting Glioma Brain Tumors NEW YORK, April 8, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for SL-701, which enables the company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in first recurrence. SL-701 is a subcutaneously-administered cancer vaccine comprised of multiple synthetic peptides engineered for increased immunoreactivity against targets overexpressed on the cancer stem cells (CSCs) and tumor bulk of gliomas, the most common type of brain cancer. It is based on a vaccine developed at the University of Pittsburgh that demonstrated single agent clinical efficacy, including complete responses (CRs) and partial responses (PRs), in Phase 1/2 trials conducted by the university in both adults and children with high-grade gliomas, including GBM. The Stemline-sponsored trial is an 80-100 patient multi-center study, designed to evaluate SL-701 in adults with GBM that has recurred following initial treatment with surgery, radiation, and chemotherapy. Overall response rate and survival are co-primary endpoints.

 


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