|Apricus gets Health Canada approval. Vanda rallies on IRS ruling. Cytori trial shows positive results|
|By BioMedReports.com Staff|
|Monday, 15 November 2010 19:51|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 15, 2010.
Shares of Apricus Biosciences, Inc. (Nasdaq:APRI) were on the move Monday after the company announced that Health Canada has granted marketing approval for Vitaros as a first-line therapy for erectile dysfunction. Vitaros is Apricus Bio’s proprietary, topically-applied, on-demand treatment for erectile dysfunction.
Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, "We at Apricus Bio are thrilled to have received this approval from Health Canada. The achievement of this milestone is a testament to the focus and dedication of the Apricus Bio team and our success in executing on our stated growth strategy."
Heavy volume sent shares of Apricus up 17 cents, more than 8% to $2.26.
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) shares rallied today after the company said that it has received a ruling (PLR) from the Internal Revenue Service regarding certain income tax issues associated with the availability of Vanda's net operating loss carryforwards for tax purposes. The PLR is generally consistent with Vanda's stated tax position that it is able to offset a portion of its 2010 taxable income with the company's full net operating loss carryforwards. Total net operating loss carryforwards were $123 million as of December 31, 2008. As of December 31, 2009, total net operating loss carryforwards were $156 million.
Vanda believes that the PLR received from the IRS clarifies certain tax rules regarding the use of these net operating loss carryforwards and will support Vanda's position that it's December 31, 2009 net operating loss carryforwards can be fully utilized beginning in 2010.
"We are very pleased with this IRS ruling which is consistent with our prior analysis and will aid us in maximizing the utilization of our prior year net operating loss carryforwards and thereby minimizing our tax payment obligations for this year," said Mihael H. Polymeropoulos M.D., Vanda's President and CEO.
On Nasdaq, shares of Vanda shot up 96 cents or 12.47% to $8.66.
Shares of Cytori(NASDAQ:CYTX) gained Monday after the company reported that Adipose (fat) tissue-derived regenerative cells (ADRCs) obtained using the Celution® System demonstrated a statistically significant improvement in cardiac functional capacity (MVO2) at 18 months. New data from the PRECISE trial for chronic myocardial ischemia trial were presented today at the American Heart Association Scientific Sessions 2010.
CYTX rose 20 cents to $4.68.
BSD Medical Corporation (NASDAQ:BSDM) shares were under pressure today after the company announced that it entered into a securities purchase agreement with two existing institutional investors for the sale of 1,750,000 shares of stock in a direct offering priced at $5.97 per share.
Shares dropped nearly 15% or $1.02, closing Monday's session at $6.01.
Shares of StemCells, Inc. (Nasdaq:STEM) saw heavy action after the company announced today that is has filed an application with Swissmedic, the Swiss regulatory agency for therapeutic products, to conduct a clinical trial in Switzerland of the Company's HuCNS-S purified human neural stem cells in chronic spinal cord injury patients. If authorized, the study would enroll patients who are three to 12 months post-injury.
"With this filing we have taken a tangible step to broaden the clinical development of our HuCNS-SC product candidate beyond the brain and into the spinal cord," said Martin McGlynn, President and CEO of StemCells, Inc. "This exciting initiative is supported by extensive preclinical research demonstrating the ability of our proprietary cells to restore lost motor function when transplanted in the chronic spinal cord injury setting. The prospect of extending the treatment window to months or longer following injury would mean that a much larger population of injured patients could potentially benefit from such an approach."
Also Monday:Adherex Technologies Inc. (TSX:AHX)(PINK SHEETS:ADHXF), a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today reported recent developments and financial results for the third quarter ended September 30, 2010.
Amarin Corporation plc (Nasdaq:AMRN) today announced that it is scheduled to present at the Lazard Capital Markets 7th Annual Healthcare Conference on Tuesday, November 16, 2010 at 3:10pm.
BioMed Realty Trust, Inc. (NYSE:BMR) announced today that members of its executive management will present at the National Association of Real Estate Investment Trust's (NAREIT) REITWorld 2010® in New York City on Monday, November 15, 2010 at approximately 4:10 p.m. Eastern Standard Time.
Cardium Therapeutics (NYSE Amex:CXM) reported on the presentation of results from the Company's sponsored preclinical research at the American Heart Association 2010 Annual Meeting Scientific Sessions being held November 13 – 17, 2010 in Chicago, IL.
Celsius Holdings, Inc. (NASDAQ: CELH) announced today new relationships with Select Nutrition Distributors, a division of UNFI, and Natrol to further expand its distribution to health and nutrition retailers.
Celsion Corporation (Nasdaq:CLSN), a biotechnology drug development company, today announced financial results for the third quarter and nine months ended September 30, 2010 and addressed the progress of its clinical trials of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.
China Biologic Products, Inc. (Nasdaq:CBPO) ("China Biologic," or the "Company"), a leading plasma-based biopharmaceutical company in China, today announced that the Company's management will present at the upcoming Brean Murray, Carret & Co. 2010 China Growth Conference.
Cytta Corp. (OTCBB: CYCA) is pleased to announce that the Company has successfully acquired the licenses necessary to become a Health based Mobile Virtual Network Operator (MVNO) in the USA.
Dyadic International, Inc. (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme and protein products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced financial results for the third quarter ended September 30, 2010.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that in addition to the improved survival seen in inoperable aortic stenosis patients treated with the Edwards SAPIEN transcatheter heart valve in The PARTNER Trial, a newly released analysis of the same patients shows that they also experienced substantially better quality of life.
Entest BioMedical Inc. (OTCBB: ENTB) announced today it has added Dr. Gregory McDonald to its Scientific Advisory Board (SAB).
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced Phase 2 results demonstrating that Insulin-PH20 (recombinant human insulin with rHuPH20) produced glycemic control comparable to lispro, a widely prescribed prandial (mealtime) insulin analog.
Hard to Treat Diseases, Inc. (PINK SHEETS:HTDS) is targeting a merger with a Canadian biotechnology company that deals with blood transfusion products.
Healthnostics, Inc. (PINKSHEETS: HNSS) is implementing its 3-S Program of "speed, space, and specialization" by unveiling its One-Machine-One-Product concept and announced the building of three new medical product manufacturing machines based upon the same technology as its fill-and-seal MicroFill-2160 machine announced in October.
InfuSystem Holdings, Inc. (OTCBB:INHI) (OTCBB: INHIW) (OTCBB: INHIU), the leading provider of infusion pumps and associated clinical services, announced today that it will present at the following upcoming investor conferences.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the Lazard Capital Markets 7th Annual Healthcare Conference, being held at the St. Regis Hotel in New York City.
Leatt Corporation, a Nevada corporation (PINKSHEETS: LEAT) and thedistributor of the Leatt-Brace®, a Neck Brace System designed to help prevent potentially devastating motor sport injuries to the cervical spine (neck), today announced unaudited financial results for its fiscal 2010 third quarter ended September 30, 2010.
Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, has been issued two key patents by the U.S. Patent and Trademark Office (USPTO).
Medical Marijuana Inc (PINKSHEETS: MJNA) applauds Arizona voters for approving Proposition 203, which legalizes marijuana for medical use.
MMRGlobal, Inc. (OTCBB: MMRF) a provider of easy-to-use and cost-effective Personal Health Records and electronic document management solutions for healthcare professionals, reported today that for the third quarter ended September 30, 2010, earnings increased in every category, as compared to the second quarter of 2010.
MusclePharm Corporation (OTCBB:MSLP) is pleased to announce that the company has retained Mina Mar Group to assist MSLP with mergers and acquisitions (MA), and Mina Mar Marketing Group as the company's investor relations (IR) provider.
NeoGenomics, Inc. (OTC Bulletin Board:NGNM) announced today that it will present at the Lazard Capital Markets 7th Annual Healthcare Conference being held November 16-17, 2010, at the St. Regis, New York Hotel in New York City.
NMT Medical, Inc. (NASDAQ: NMTI) an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced final results of its pivotal CLOSURE I study at the American Heart Association's (AHA) Late-Breaking Clinical Trials Sessions 2010 in Chicago, Illinois.
Oramed Pharmaceuticals Inc. (OTCBB: ORMP) a developer of oral drug delivery systems, presented the results of its recently completed Phase IIb trial.
Palatin Technologies, Inc. (NYSE Amex:PTN), a biopharmaceutical company dedicated to the development of peptide mimetic and small molecule agonist compounds with a focus on melanocortin and natriuretic peptide receptor systems, today announced results for its first quarter ended September 30, 2010.
Pfizer Inc. (NYSE:PFE) today announced results from the EMPHASIS-HF trial(1) showing a statistically significant reduction in risk of cardiovascular (CV) death or heart failure (HF) hospitalization for patients with chronic heart failure with mild symptoms treated with Inspra® (eplerenone) versus those given placebo in addition to standard HF therapy.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today the launch of a new version of its Onko-Sure® product website.
Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and manufacturing of oral care and cosmetic dentistry products, reported results for the second quarter ended on September 30, 2010 (in US Dollars).
RXi Pharmaceuticals Corporation (Nasdaq:RXII), a recognized leader in RNAi-based therapeutic discovery and development, today reported its financial results for the third quarter ended September 30, 2010.
It is with great sadness that Sigma-Aldrich Corporation (Nasdaq:SIAL) announces that Dr. Jai P. Nagarkatti, its Chairman, President and CEO, died suddenly and unexpectedly of an apparent heart attack Saturday, November 13, 2010 in St. Louis, Missouri. He was 63 years old.
Stellar Biotechnologies, Inc. (TSX-VLH) (PINKSHEETS: SBOTF) is pleased to announce that it has closed the non-brokered private placement announced on October 25, 2010, as amended November 3, 2010, by the issuance of 6,213,000 units at a price of $0.60 per unit to raise gross proceeds of $3,727,800.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that the Company will participate in the Maxim Group Growth Conference on Thursday, November 18, 2010, in New York City.
Sigma-Aldrich (Nasdaq:SIAL) is pleased to announce the appointment of Kirk Richter to the role of Interim Chief Financial Officer (CFO). He currently serves as Vice President and Treasurer, duties that he will continue to perform.
Spring Creek (OTCBB: SCRK) announces that its wholly owned subsidiary, DelRX Pharmaceutical Corp., has signed an LOA for licensing its proprietary drug delivery system to TheraBiogen, Inc., an affiliate company.
SHG Services, Inc. ("New Sun") (NASDAQ: SNHD), today announced thatthe previously announced plan of its former parent company, Sun Healthcare Group, Inc. ("Old Sun"), to restructure Old Sun's business by separating Old Sun's operating assets and its real estate assets into two separate publicly traded companies has been completed.
Unilens Vision Inc. (OTCBB: UVIC) (TSX-V: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today reported its operating results for the first quarter of FY2011.
ViroPharma Incorporated (Nasdaq:VPHM) today announced data in four poster presentations and two oral presentations relating to Cinryze® (C1 esterase inhibitor [human]) at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), November 11 through 16 in Phoenix, Ariz.
Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT) a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced record fiscal 2010 third quarter results for period ended September 30, 2010.
ZYTO Corp (PINKSHEETS: ZYTC) has announced initial sponsors for its 6th Annual Conference to be held April 28-30, 2011 in Salt Lake City, Utah.