FURX To Be Snapped Up, NVIV Initiates First Clinical Trial, NVAX Up After-hours

(RTTNews) - BioMarin Pharmaceutical Inc.'s (BMRN) enzyme replacement therapy VIMIZIM has received European Commission approval for treating Morquio A Syndrome in patients of all ages.

VIMIZIM has been granted orphan drug status in the European Union, which confers ten years of market exclusivity.

Morquio A, also known as Mucopolysaccharidosis type IVA, is an inherited condition that affects major organ systems in the body. People born with Morquio A are missing or don't make enough of an important enzyme and, as a result, they can't break down certain materials in the body.

The FDA approved VIMIZIM for patients with Morquio A syndrome on February 14, 2014. BioMarin has also submitted marketing applications for VIMIZIM in Brazil, Australia, Canada, Mexico, and Japan.

BMRN closed Monday's trading at $57.49, up 0.70%.

CytRx Corp. (CYTR) will be presenting updated progression-free survival and overall survival results from its completed phase 1b/2 clinical trial of Aldoxorubicin in soft tissue sarcoma on May 2.

Aldoxorubicin is currently being studied in a pivotal global phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA. The company is also conducting two Phase 2 clinical trials evaluating aldoxorubicin in patients with late-stage glioblastoma (GBM) and HIV-related Kaposi's sarcoma.

CYTR closed Monday's trading at $3.01, down 0.33%.

Forest Laboratories Inc. (FRX), which itself is all set to be acquired by Actavis plc (ACT), has opened its wallet to purchase Furiex Pharmaceuticals Inc. (FURX) for $95 per share, or about $1.1 billion in cash, and up to $30 per share (approximately $360 million in aggregate) in a Contingent Value Right upon achievement of certain designations following FDA review of eluxadoline, Furiex's lead product candidate for irritable-bowel-syndrome.

Furiex plans to submit a New Drug Application for eluxadoline by the end of the third quarter of 2014.

Forest's planned acquisition of Furiex is expected to close in the second or third quarter of 2014 pending regulatory review. The acquisition of Forest Labs by Actavis for approximately $25 billion is expected to close in mid-year 2014.

FURX rose 28.57% to close Monday's trading at $103.05.

GW Pharmaceuticals plc (GWPH) investigational product Sativex, under phase III testing for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy, has received fast track designation from FDA.

GWPH closed Monday's trading at $65.24, up 5.02%.

IntelGenx Corp. (IGX.V) (IGXT.OB) and RedHill Biopharma Ltd. (RDHL) has initiated a comparative bioavailability clinical study comparing their anti-migraine VersaFilm Product to the European reference drug in order to support the planned submission of a European Marketing Authorization Application.

VersaFilm was issued a Complete Response Letter by FDA in February 2014, citing issues related to Chemistry, Manufacturing and Controls. The companies continue to work with the FDA in order to address and resolve the CMC questions.

IGXT.OB closed Monday's trading at $0.81, down 0.61%.

InVivo Therapeutics Holdings Corp. (NVIV) has initiated the first clinical trial evaluating its investigational device, a degradable polymer Neuro-Spinal Scaffold, for spinal cord injury patients.

The study, which is a pilot trial, will evaluate preliminary safety and effectiveness of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

NVIV surged 22.67% to close Monday's trading at $1.84.

Novavax Inc. (NVAX) rose over 9 percent in extended trading on Monday to $4.30, following the announcement of positive top-line safety and immunogenicity data from its respiratory syncytial virus F-protein nanoparticle vaccine candidate in a phase II clinical trial in women of childbearing age.

OncoGenex Pharmaceuticals Inc. (OGXI) plunged more than 60 percent to $3.85 on Monday as a phase III trial evaluating its drug candidate Custirsen for metastatic castrate-resistant prostate cancer failed to meet the primary endpoint of a statistically significant improvement in overall survival.

The trial, dubbed SYNERGY, compared Custirsen plus standard first-line docetaxel/prednisone therapy to docetaxel/prednisone alone.

Syneron Medical Ltd. (ELOS) said its subsidiary in Japan, Candela KK, has received approval to market ALEX II system, a single wavelength Q-switched alexandrite laser, in Japan for the treatment of benign dermal lesions.

ELOS closed Monday's trading at $10.48, down 1.04%.