|Active Stocks: IGI Laboratories, AbbVie Inc, Echo Therapeutics, Rexahn Pharmaceuticals, Orthofix International|
|By Marilyn Mullen|
|Thursday, 25 September 2014 14:16|
Stocks fell sharply and Treasury bonds rallied as investors piled into assets seen as safe amid stepped-up worries over global economic growth.The Dow Jones Industrial Average sank 245 points, or 1.4%, to 16965, giving back all of the prior day's gains. The S&P 500 fell 29 points, or 1.5%, to 1969. The Nasdaq NDAQ -1.61% Composite Index declined 83 points, or 1.8%, to 4472. The S&P 500 was on track for its biggest one-day slide since late July. Traders pointed to no single factor behind the slide, saying that a confluence of concerns about economic growth, as well as fears of an escalation in tensions between Western countries and Russia, have sent investors falling back on safe-haven assets.
IGI Laboratories, Inc. (NYSEMKT:IG) acquires the regulatory rights to 18 drug products from AstraZeneca (NYSE:AZN) that it no longer actively markets. The group includes 17 injectables and one suppository. All had been cleared by the FDA via ANDAs or NDAs prior to their discontinuation or withdrawal from the market. According to IMS Health, the U.S. addressable market for the products is ~$200M.Almost half of the 18 drugs are on the FDA shortage list.
The FDA approves AbbVie Inc. (NYSE:ABBV) Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients six years of age and older when certain other treatments have not worked well enough. The approval, Humira's eighth indication, makes it the first and only biologic treatment cleared for use in this patient population that can be administered at home (after proper injection training).
Following the recent suspension of its operations, Echo Therapeutics Inc. (NASDAQ:ECTE) has laid off 70% of its workforce. The affected employees weren't offered severance pay. However, Echo may "incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the workforce reduction."
The FDA has granted orphan status to Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) RX-3117 pancreatic cancer drug. Patients are being enrolled in a Phase 1b clinical trial that's expected to be completed during Q1 2015. Rexahn notes pre-clinical studies have shown RX-3117 "maintains its anti-tumor activity in human cancer cell lines" that are resistant to widely-used chemotherapy drug gemcitabine. Up to 40% of pancreatic cancer patients treated with gemcitabine have become resistant to the drug after 30 days.
Needing several more weeks to physically count its consignment inventory of Spine Fixation devices, Orthofix International NV (NASDAQ:OFIX) says the filing of its restated financial statements for the fiscal years 2011, 2012 and 2013 and Q1 2014 will be delayed past the target of September. It also states that it plans to file its Q2 2014 10-Q at the same time and that these activities may delay its Q3 2014 closing.