Onconova (ONTX) Soars on FDA Submission for HR-MDS Drug
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For its second quarter 2015, JWN posted net sales of $3.6 billion, a 9.2% increase year over year, and earnings per diluted share of $0.93 per share (excluding $0.16 gain from the reclassification of receivables as "held for sale" associated with the pending credit card transaction), topping the Capital IQ Consensus Estimate of $0.90 earnings per share for the period
On May 26, 2015, JWN announced its strategic credit card relationship with TD Bank, including the sale of its existing U.S. Visa and private label consumer credit card portfolio. JWN also entered into a program agreement with TD Bank, in which it will be entitled to a substantial portion of net revenue generated by the credit card portfolio.
Upon closing, JWN expects to receive approximately $1.8 billion, net of $325 million in debt reduction and transaction costs. In the second quarter, JWN reclassified its receivables to "held for sale" resulting in the reduction of expense.
JWN has raised its guidance for fiscal year 2015 and now expects net sales growth to be in the range of 8.5% to 9.5% (from the prior range of 7% to 9%) and Earnings per diluted share (excluding non-recurring items) to be in the range of $3.70 to $3.80 (from the previous range of $3.65 to $3.80)
JWN is a leading fashion specialty retailer based in the U.S.
More about Nordstrom Inc. (JWN) at www.nordstrom.com
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Shares of Onconova Therapeutics, Inc. (ONTX) soared over 25% during the extended session Thursday after the company announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy, which positions ONTX's rigosertib back on an approval track in HR-MDS.
ONTX's rigosertib is a small molecule that inhibits cellular signaling by acting as a Ras mimetic. This is believed to be mediated by direct binding of rigosertib to the Ras-binding domain found in many Ras effector proteins, including the Raf kinases and PI3K. The initial therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia
Upon clearance, the IND enables ONTX to initiate a randomized, controlled pivotal Phase 3 trial in patients with HR-MDS that have failed prior HMA therapy. ONTX also said that it plans to submit Clinical Trial Applications in several European countries shortly and the company anticipates initiating enrollment in the new Phase 3 study in the second half of 2015.
ONTX is a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer.
More about Onconova Therapeutics, Inc. (ONTX) at www.onconova.com
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