08.09.2015 06:29:19
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ECYT Hits Target, Starpharma Inks Deal, It's 29 For IG, ALXN's FDA Date Revised
(RTTNews) - The FDA decision date on Alexion Pharmaceuticals Inc.'s (ALXN) Biologics License Application seeking approval of Kanuma for the treatment of lysosomal acid lipase deficiency has now been postponed by three months to December 8, 2015.
ALXN closed Friday's trading at $171.98, down 1.88%.
BioTime Inc. (BTX), whose common shares are currently listed on NYSE MKT, will also be listed on the Tel Aviv Stock Exchange beginning September 8, 2015 under ticker symbol BTX.
Based on the current market capitalization, BioTime's shares are anticipated to be included in five TASE equity indexes: TASE's TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed.
The company said that the dual listing on the TASE will help to open a new access point for its shares in the Israeli market that is becoming a center for biomed and emerging technology companies.
BTX closed Friday's trading 8.05% higher at $3.22.
Endocyte Inc.'s (ECYT) phase II2b trial evaluating Vintafolide in combination with Docetaxel in non-small cell lung cancer, which had earlier met the primary endpoint of progression free survival, supports Folate Receptor as a valid target in non-small cell lung cancer, the company said.
The results from the trial, dubbed TARGET, demonstrated that Vintafolide plus Docetaxel improved overall survival by 2.7 months in NSCLC. In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of folate receptor, Vintafolide plus Docetaxel improved overall survival by 5.9 months.
ECYT closed Friday's trading at $5.03, down 2.33%.
Genmab A/S's (GNMSF.OB) Biologics License Application for Daratumumab for double refractory multiple myeloma has been granted priority review by the FDA - with a decision date set for March 9, 2016.
GNMSF.OB closed Friday's trading at $90.76, unchanged from the previous day's close.
IGI Laboratories Inc. (IG) has submitted its seventh abbreviated new drug application of this year to the FDA. With this submission, the company's total number of ANDA submissions now pending at the regulatory agency is twenty-nine.
IG closed Friday's trading at $8.08, down 1.70%.
Australian biotech firm Starpharma (SPHRY.OB) has signed a drug delivery license agreement with AstraZeneca plc (AZN). The agreement enables the development and commercialization by AstraZeneca of compounds directed at a defined family of targets using Starpharma's DEP drug delivery technology.
Starpharma's dendrimer drug delivery technology, or DEP, is about working to ensure that the drug is delivered to the right part of the body at the right time. Dendrimers are manmade, nanoscale compounds.
Under the terms of the agreement, Starpharma stands to receive upfront and milestone payments totaling US$126 million for the first AstraZeneca DEP product and up to US$93.3 million for each subsequent qualifying product.
SPHRY.OB closed Friday's trading at $4.32, unchanged from the previous day's close.
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