15.07.2016 06:20:54
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Watch Out For BCLI, RARE's Phase 3 Trial Hits Goal, JUNO Opens Wallet
(RTTNews) - Arena Pharmaceuticals Inc.'s (ARNA) FDA-approved weight loss drug BELVIQ has won regulatory approval in Mexico, where it will be sold under the name VENESPRI by Eisai Laboratorios, S. de R.L. de C.V.
The product is expected to become available in Mexico later this year. In connection with the approval Arena will receive a $1 million milestone payment.
ARNA closed Thursday's trading at $1.63, up 1.87%.
BrainStorm Cell Therapeutics Inc. (BCLI) is scheduled to announce results from the recently completed phase II Study of NurOwn in Patients with Amyotrophic Lateral Sclerosis on Monday, July 18, 2016.
Amyotrophic lateral sclerosis, often referred to as "Lou Gehrig's Disease, is a progressive fatal neurodegenerative disease that affects nerve cells in the brain and the spinal cord, causing muscle weakness, paralysis, and ultimately, respiratory failure.
NurOwn consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors to support and repair damaged neurons.
BCLI closed Thursday's trading at $3.56, up 32.84%.
Shares of CytRx Corp. (CYTR) were down over 24% in extended trading on Thursday, following a proposed registered public offering of the company's common stock and warrants.
The company intends to use the net proceeds from the offering, if completed, for working capital and general corporate purposes.
Earlier in the week, the company reported disappointing results from its phase III clinical trial of Aldoxorubicin in patients with relapsed or refractory soft tissue sarcomas, which lead to the stock losing over 60% of its value in a single day.
CYTR closed Thursday's trading at $0.89, down 8.27%. In after hours, the stock fell another 24.35% to $0.68.
Juno Therapeutics Inc. (JUNO) has acquired RedoxTherapies Inc., a privately held company based in Boston, Massachusetts, for an upfront payment of $10 million in cash with clinical and commercial milestones.
The acquisition provides Juno with an exclusive license to Vipadenant, an orally bioavailable synthetic small molecule that helps to overcome the tumor microenvironment, and proprietary know-how and intellectual property pertaining to the development of A2aR antagonists in combination with immuno-modulatory agents.
JUNO closed Thursday's trading at $28.80, down 5.33%.
Revance Therapeutics Inc. (RVNC) is all set to initiate phase III clinical trials for RT002 injectable to treat glabellar lines in the second half of 2016.
The phase III program will include two placebo-controlled pivotal studies conducted at multiple sites in the US and Canada. The primary endpoint of these studies will be a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment and patient assessment scales, at maximum contraction (frown), at Week 4, noted the company.
RVNC closed Thursday's trading at $13.84, up 1.32%.
Ultragenyx Pharmaceutical Inc. (RARE) has reported positive data from a pivotal phase III study of recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of Mucopolysaccharidosis 7.
The study met its primary endpoint of reducing urinary GAG (dermatan sulfate) excretion after 24 weeks of treatment, demonstrating a reduction from baseline of 64.8 percent.
Based on the encouraging data, the company plans to meet with the FDA and EMA this year to discuss its plans to submit regulatory filings in the first half of 2017.
Mucopolysaccharidosis 7 is a rare genetic, metabolic disorder caused by the deficiency of beta-glucuronidase, an enzyme required for the breakdown of the glycosaminoglycans (GAGs) dermatan sulfate and heparan sulfate.
RARE closed Thursday's trading at $49.54, down 2.58%. In after hours, the stock was up 2.34% to $50.70.
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