Shares of Actavis Inc. (ACT) touched an all-time high of $121.56 on Monday before closing the day's trading at $120.52. The company's New Drug Application for a progestin-only transdermal contraceptive patch for use by women to prevent pregnancy has been accepted for review by FDA, with a decision date set for December 27, 2013.
Biogen Idec's (BIIB) Biologics License Application seeking approval of ELOCTATE for the treatment of hemophilia A has been accepted for review by the FDA. The company's product candidate ALPROLIX for the treatment of hemophilia B was accepted for review by the FDA on March 4, 2013. Both the product candidates are under standard review.
BIIB closed Monday's trading at $222.74, up 4.46%. In after-hours, the stock gained 0.12% to $223.
Bioniche Life Sciences Inc. (BNC.TO) announced Monday that it has engaged Evercore Partners to assist in the divestment of its Animal Health Business. The company also said that it is actively engaged in discussions with potential partners for its phase III bladder cancer product, Urocidin.
BNC.TO gained 4.17% on Monday to close at C$0.25.
BioTime Inc.'s (BTX) subsidiary Cell Cure Neurosciences Ltd. has been awarded a grant of approximately $1.5 million from Israel's Office of the Chief Scientist for this year to help fund the development of OpRegen.
OpRegen is a cell-based therapeutic product in development by Cell Cure Neurosciences for the treatment of age-related macular degeneration. Cell Cure Neurosciences plans to complete preclinical testing of OpRegen and file an application to commence human clinical trials in 2014.
BTX closed Monday's trading 2.94% higher at $4.20.
BSD Medical Corp.'s (BSDM) exclusive Taiwan distributor Linden Bioscience Co., Ltd. is seeking approval for BSD-2000 Hyperthermia System from the Taiwan Food and Drug Administration. The BSD-2000 is expected to be approved by the TFDA as early as November 2013.
In the U.S., the BSD-2000 has Humanitarian Device Exemption marketing approval for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE Marking approval for the commercial sale in Europe.
BSDM closed Monday's trading at $1.15.
Shares of Cempra Inc. (CEMP) were up more than 7% to $7.20 in extended trading on Monday after the company announced that it has signed an exclusive license and development agreement for one of its lead product candidates, Solithromycin, with Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corp. in Japan.
Solithromycin is under phase III development for Community Acquired Bacterial Pneumonia.
Cempra will receive an upfront payment of $10 million as well as up to $60 million in milestone payments from Toyama based on the achievement of certain objectives. Tiered royalties that will be adjusted based on sales are expected to be paid to Cempra following launch of Solithromycin in Japan.
Merrimack Pharmaceuticals Inc. (MACK) has a couple of events expected to take place in the second half of 2013 namely, release of top line results from a phase IIII trial of MM-398 in second line pancreatic cancer and phase II trials of MM-121 in breast, ovarian and non-small cell lung cancers.
MACK closed Monday's trading at $5.17, up 1.97%.
Shares of Nanosphere Inc. (NSPH) rose more than 17% to $3.27 in after-hours on Monday, following the announcement of a distribution and collaboration agreement with Hitachi High-Technologies Corp.
The agreement grants Hitachi High-Tech exclusive rights to market Nanosphere products in Japan, expanding Nanosphere's product reach into one of the largest healthcare markets in the world.
Neuralstem Inc. (CUR) will present updated phase I data from a phase I trial of NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis at the Romanian Neurological Society Congress held in Bucharest, Romania, on May 17th. The trial recently received FDA approval to advance to phase II.
CUR closed Monday's trading 3.10% higher at $1.33.
Shares of Theravance Inc. (THRX) touched an all-time high of $41.23 on Monday before closing at $41.20, following a billion dollar royalty deal with Elan Corp. plc (ELN).
Under the terms of the agreement, Elan will make a one-time cash payment of $1.0 billion to Theravance in exchange for a 21% participation interest in the potential future royalty payments related to four respiratory programs partnered with GlaxoSmithKline plc namely, RELVAR ELLIPTA/BREO ELLIPTA; ANORO ELLIPTA; MABA monotherapy and vilanterol monotherapy when, as and if received by Theravance.
Trius Therapeutics Inc. (TSRX) has received a Notice of Allowance from the U.S. Patent and Trademark Office on an application related to its experimental novel antibiotic, tedizolid phosphate. This newly allowed patent application protects a therapeutic combination of tedizolid phosphate with a currently available antibiotic daptomycin.
TSRX touched a new 52-week high of $7.84 on Monday before closing at $7.53.
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