Below is a look at some of the headlines for companies that made news in the healthcare sector on April 13, 2011.
Shares of GTx, Inc. (Nasdaq:GTXI) a biopharmaceutical company dedicated to the discovery, development and commercialization drugs to treat cancer and the side effects of anticancer therapy, cancer supportive care and other serious medical conditions, shot up nearly 34% on Wednesday after the company's stock was upgraded from hold to a buy from Citigroup. The company recently reported encouragin results on its experimental prostate cancer drug, Capesaris and is planning to launch a phase II trial for the drug in Q2 2011.
In heavy trading, shares of GTx soared to an intra-day high of $4.18 before settling the day at $3.68, up 93 cents.
Delcath Systems, Inc. (NASDAQ:DCTH) today announced that the Company has been notified of CE Mark approval for its proprietary Hepatic CHEMOSAT Delivery System. The product has been approved with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
CE Marking confirms that a medical device complies with the Essential Requirements of the Medical Device Directive, and that the device has been subjected to conformity assessment procedures. Receipt of the CE Mark allows Delcath to market and sell the product in countries in the European Economic Area.
"Receipt of our CE Mark represents the first regulatory approval for this product, and marks the beginning of the Company's transition into a fully commercial enterprise," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "With its rising liver cancer rates, Europe represents a large opportunity for this product. We believe the Hepatic CHEMOSAT Delivery System may ultimately fulfill an annual unmet clinical need for as many as 100,000 liver cancer patients in this region. With the CE Mark in hand, we will now begin to build inventory and establish the commercialization infrastructure in Europe, including assembling a direct sales organization to cover countries in Northern Europe and establishing a network of third party distributors in Southern Europe. We will also begin establishing and training initial sites in select European countries as Centers of Clinical Excellence for the chemosaturation procedure." Delcath Systems soared nearly 19% or $1.37 to $8.63.
iBio, Inc. (NYSE AMEX: IBIO) today announced release of results from a series of scientific studies of the breadth of product applicability of its iBioLaunch technology. The results were published in a supplemental edition of the scientific journal Human Vaccines. The peer-reviewed scientific manuscripts describe both vaccine applications and monoclonal antibody applications of iBio’s proprietary plant-based protein expression technology.
"iBio’s platform-as-product business strategy is based on a substantial body of peer-reviewed scientific evidence that the iBio technology offers unique commercial advantages over conventional approaches for the development and manufacture of vaccines and therapeutic proteins," said Robert Erwin, iBio’s President. "These newly published data reflect pre-clinical work completed by our research collaborator, Fraunhofer USA Center for Molecular Biotechnology, more than a year ago that formed the basis for our current clinical trials and ongoing examination of the limits, if any, of our technology for the commercial expression of proteins for vaccines and biotherapeutics." Shares gained 25 cents or 9.35% to $2.92.
Apricus Biosciences, Inc. (Nasdaq:APRI) announced today its filing with the U.S. Food & Drug Administration requesting orphan drug designation for RayVa, the Company's drug candidate indicated for the treatment of Raynaud's phenomenon in patients with systemic sclerosis.
Raynaud's phenomenon is a condition in which the blood supply to fingers or toes is suddenly reduced. With less blood, the skin turns pale or white, and the fingers or toes become cold and numb. Shares gained 34 cents or 7.36% to $4.96.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report positive new results from the 39-45 month follow-up study of patients treated with NX-1207 in Study NX02-0016. The initial study, completed in the U.S. in 2007, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months post-treatment with NX-1207 2.5 mg. The new study assessed American Urological Association BPH Symptom Index scores in blinded subjects without additional NX-1207 treatment after 39-45 months. There were no significant drug safety problems reported by any subjects in the study initially as well as in the new long-term follow-up.
Perrigo (Nasdaq:PRGO) today announced that its partner, Teva Pharmaceutical Industries, Ltd. (Nasdaq:TEVA), has received final OTC approval to sell and distribute fexofenadine HCl 60 mg and 180 mg tablets; the generic equivalents of Sanofi-Aventis' Allegra 60 mg and 180 mg products. Teva has had Rx approval for these products, and Teva and Sanofi-Aventis have settled their Paragraph IV/Hatch-Waxman litigation relating to the Allegra brand family of products.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), today announced that following completion of three and six month clinical follow-up, data from its two open-label, dose-escalation, Phase I clinical trials conducted in the US and Germany suggests that Pluristem's placenta-derived cell therapy, PLX-PAD, is safe, improves quality of life, and is potentially effective in treating patients and reducing amputations in those suffering from Critical Limb Ischemia (CLI), the end-stage of Peripheral Artery Disease (PAD). Among the 27 patients treated with PLX-PAD, only one amputation was recorded, representing a 3.7% amputation rate. This represents a 75% reduction in amputation rate compared to historical data, which varies from 20-40%. Shares rose 16 cents or 5.42% to $3.11.
AeroGrow International, Inc. (OTCBB: AERO) ("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, announced that it has committed, subject to certain conditions being met, to form a joint venture with Cyrano Partners, LLC ("Cyrano")to expand distribution of AeroGrow-branded indoor gardens, seed kits, and accessories into the multi-level marketing ("MLM") sales channel.
Allezoe Medical Holdings, Inc., (OTCBB:ALZM) ("Allezoe", "ALZM" or the "Company") a publicly-traded holding company in the medical device market, and sole shareholder of Organ Transport Systems, Inc. ("OTS"), today reported that OTS has received a letter of resignation from Tommy Thompson, former Governor of Wisconsin and former Secretary of the Department of Health and Human Services, as a member of the Board of Directors of OTS.
Amunix, Inc. today announced that it has entered into an exclusive worldwide research collaboration and option agreement with Biogen Idec (NASDAQ: BIIB) to research and develop novel, fully-recombinant blood factors (Factors IX, VIII and VIIa) with improved therapeutic properties.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the first quarter 2011 on Tuesday, May 3, 2011, after the close of the market.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended March 31, 2011 after the market closes on Wednesday, April 20, 2011 and will host a conference call at 5:00 p.m. ET that day to discuss its results.
Given Imaging (NASDAQ: GIVN), today announced that the company will host conference calls on Thursday, May 5, 2011 to discuss first quarter 2011 financial results.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced details today relating to its first quarter 2011 earnings announcement, which will take place on Wednesday, May 4, 2011, after the close of the market.
Stellar Pharmaceuticals Inc (OTCQB:SLXCF) and Watson Pharmaceuticals, Inc. (NYSE:WPI) today announced that they have reached agreement to terminate the supply and licensing agreements related to Uracyst® (sodium chondroitin sulfate solution 2.0%) for the treatment of interstitial cystitis.
Taglich Brothers, Inc. is pleased to announce that Stephen Turner, President & CEO of SCOLR Pharma, Inc. (OTCQB: SCLR) (PINKSHEETS: SCLR), will be presenting at our 8th Annual Small Cap Equity Conference May 3rd, 2011.
"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.
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