Key Developments: Stemline Therapeutics Inc (STML.OQ)

STML.OQ on NASDAQ Stock Exchange Capital Market

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30 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Stemline Therapeutics announces opening of SL-401 corporate IND and start of clinical trials in BPDCN and AML
Monday, 28 Jul 2014 06:00am EDT 

Stemline Therapeutics Inc:Says opening of its SL-401 Investigational New Drug (IND) and initiation of a broad clinical development program including trials in blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia (AML).SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of many hematologic cancers.  Full Article

Stemline Therapeutics Inc announces FDA acceptance of IND for SL-701, Synthetic Multi-Peptide Vaccine Targeting Glioma Brain Tumors
Tuesday, 8 Apr 2014 07:00am EDT 

Stemline Therapeutics Inc:US FDA has accepted company's Investigational New Drug (IND) application for SL-701, which enables company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in recurrence.SL-701 is 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, most common type of brain cancer.It is based on vaccine developed at University of Pittsburgh that demonstrated single agent clinical efficacy, including complete responses (CRs) and partial responses (PRs), in Phase 1/2 trials conducted by university in both adults and children with high-grade gliomas, including GBM.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 chemother.Overall response rate and survival are co-primary endpoints.  Full Article

Stemline Therapeutics Inc Receives Orphan Drug Designation for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Monday, 10 Jun 2013 08:00am EDT 

Stemline Therapeutics Inc announced that SL-401 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug status for the treatment of acute myeloid leukemia (AML).  Full Article

Stemline Therapeutics Inc Announces Exercise Of Option To Purchase Additional Shares
Thursday, 23 May 2013 08:30am EDT 

Stemline Therapeutics Inc announced that the underwriters have exercised in full their option to purchase an additional 620,689 shares of common stock. The option to purchase additional shares is being exercised in connection with Stemline's previously announced public offering of 4,137,931 shares of common stock at a public offering price of $14.50 per share. As a result of the exercise of the option, the total gross proceeds to Stemline from the offering are expected to be approximately $69,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses. The closing of the option to purchase additional shares is expected to occur on or about May 28, 2013.  Full Article

Stemline Therapeutics Inc Announces Closing Of $60 Million Public Offering Of Common Stock
Wednesday, 22 May 2013 09:31am EDT 

Stemline Therapeutics Inc announced the closing of its previously announced underwritten public offering of 4,137,931 shares of its common stock at a public offering price of $14.50 per share. The gross proceeds to Stemline from the public offering are $60 million, before underwriting discounts and commissions and other offering expenses payable by Stemline. Jefferies LLC and Aegis Capital Corp. acted as joint book-running managers for the offering. Roth Capital Partners acted as co-lead manager for the offering.  Full Article

Stemline Therapeutics Inc Prices $60 Million Public Offering Of Common Stock
Thursday, 16 May 2013 05:47pm EDT 

Stemline Therapeutics Inc announced that the pricing of an underwritten public offering of 4,137,931 shares of its common stock at a public offering price of $14.50 per share. Stemline has granted the underwriters a 30-day option to purchase up to 620,689 additional shares of common stock from Stemline. The gross proceeds to Stemline from the public offering are expected to be $60.0 million, before underwriting discounts and commissions and other estimated offering expenses. Stemline intends to use the net proceeds from the public offering to fund the clinical development of SL-401 and SL-701 and other general corporate purposes. Jefferies LLC and Aegis Capital Corp. are acting as joint book-running managers for the offering. Roth Capital Partners is acting as co-lead manager for the offering.  Full Article

Stemline Therapeutics Inc Announces Closing of Initial Public Offering
Thursday, 31 Jan 2013 04:08pm EST 

Stemline Therapeutics Inc announced the closing of its previously announced initial public offering of 3,815,291 shares of common stock, including the exercise in full of the over-allotment option covering 497,647 shares, at a public offering price of $10.00 per share. The gross proceeds to Stemline from the offering, including the exercise of the over-allotment option, were $38,152,910, before deducting underwriting discounts and commissions and other offering expenses payable by Stemline. Aegis Capital Corp. acted as sole book-running manager for the offering. Feltl and Company, Inc. and Sunrise Securities Corp. acted as co-managers for the offering.  Full Article

Stemline Therapeutics Inc Announces Exercise Of Over-Allotment Option
Tuesday, 29 Jan 2013 07:35pm EST 

Stemline Therapeutics Inc announced the exercise in full of the over-allotment option granted to the representative of the underwriters by Stemline with respect to the purchase of 497,647 shares of common stock at a public offering price of $10.00 per share, less underwriting discounts and commissions. The over-allotment option is being exercised in connection with Stemline's previously announced initial public offering of 3,317,644 shares of common stock. As a result of the exercise of the over-allotment option, the total gross proceeds to Stemline from the offering will be $38,152,910, before deducting underwriting discounts and commissions and other offering expenses. Aegis Capital Corp. is acting as sole book-running manager for the offering. Feltl and Company, Inc. and Sunrise Securities Corp. are acting as co-managers for the offering.  Full Article

Stemline Therapeutics Inc Announces Pricing Of Initial Public Offering Of 3,317,644 Shares Of Common Stock
Monday, 28 Jan 2013 07:52pm EST 

Stemline Therapeutics Inc announced the pricing of its initial public offering of 3,317,644 shares of its common stock offered at a price to the public of $10.00 per share. The gross proceeds to Stemline from the initial public offering are expected to be $33,176,440, before underwriting discounts and commissions and other offering expenses. Stemline has granted the representative of the underwriters a 45-day option to purchase up to 497,647 additional shares of common stock from Stemline to cover over-allotments, if any. The shares are expected to begin trading on the NASDAQ Capital Market under the symbol STML on January 29, 2013. The offering is expected to close on January 31, 2013. Aegis Capital Corp. is acting as sole book-running manager for the offering. Feltl and Company, Inc. and Sunrise Securities Corp. are acting as co-managers for the offering.  Full Article

Stemline Therapeutics Inc Announces Presentations Of SL-401 Updated Clinical Trial Results In Acute Myeloid Leukemia And Blastic Plasmacytoid Dendritic Cell Neoplasm
Friday, 7 Dec 2012 08:30am EST 

Stemline Therapeutics Inc announced that two studies featuring SL-401 updated clinical trial results in acute myeloid leukemia (AML) and other hematologic malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), and SL-101 preclinical activity against Hodgkin's lymphoma have been selected for presentation at the upcoming 54 th Annual Meeting of the American Society of Hematology (ASH) to be held in Atlanta, GA from December 8-11, 2012 . Stemline and its collaborators from MD Anderson Cancer Center and Scott and White Memorial Hospital will present the posters. The updated clinical trial results for SL-401, a novel biologic targeted therapy directed to the interleukin-3 receptor (IL-3R), demonstrated that the drug was well-tolerated at clinically active doses and showed single agent anti-tumor activity in heavily pretreated patients with AML, as well as in patients with high risk myelodysplastic syndrome (MDS) and relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). In particular, a single cycle of SL-401 demonstrated single agent activity in patients with relapsed or refractory AML, including two durable complete responses (CRs) of eight and >25 months duration, respectively, and multiple additional cases of leukemia blast reductions.  Full Article

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