|Hi-Tech moves higher on FDA approval. Sequenom surges. After the bell: Orthovita soars on 510(k) clearance. Optimer falls on offering|
|By BioMedReports.com Staff|
|Thursday, 10 February 2011 20:01|
After the bell, shares of Orthovita, Inc. (NASDAQ:VITA), surged higher after the orthobiologics and biosurgery company, announced that it received 510(k) clearance from the FDA to market Vitoss BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss Bimodal is anticipated to launch in the United States in 9-12 months after the introduction of Vitoss BA2X which will be commercially introduced by Orthovita next week at the 2011 Meeting of the American Academy of Orthopedic Surgeons.
Vitoss BA Bimodal differs from previous versions of Vitoss BA by modifying the size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass. Orthopedic and spine surgeons believe accelerated resorption is an important characteristic in grafting material.
"Surgeons need an array of spine and orthopedic bone grafting products with properties designed to fit the unique patient challenges that present each day," said Antony Koblish, President and Chief Executive Officer of Orthovita. "Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals."
In extended trading, shares of Orthovita traded as high as $2.95, 75 cents higher than Thursday close of $2.20.
Also after the bell shares of Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) traded lower after the company announced that it intends to sell shares in a public offering. Shares were trading as low as $11.58 in extended trading, down nearly $1.00 from Thursday's close of $12.57.
Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), after the market close on Thursday reported that they have filed a Special 510(k) application with the U.S. Food and Drug Administration (FDA). The application seeks marketing clearance for the Stealth 360 Orbital PAD System, a third-generation electric powered device for the treatment of peripheral arterial disease.
Shares of Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) moved higher today after the specialty pharmaceuticals company, announced today that the FDA granted final approval for the Company’s ANDA for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon’s Quixin ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for bacterial conjunctivitis. The Company is preparing to launch the product by the end of March 2011.
Sequenom (Nasdaq:SQNM) jumped more than 7% today after the company announced publication in the American Journal of Obstetrics and Gynecology of Sequenom CMM's "locked assay" study for its Down syndrome prenatal detection test.
"This important study demonstrated that massively parallel shotgun sequencing is a potentially viable path for noninvasive prenatal diagnosis of fetal Trisomy 21 and warrants its validation in a larger clinical validation study," said Harry F. Hixson, Jr. PhD, chairman and chief executive officer of Sequenom. "We are very pleased with the results from the 'locked assay' study and are looking forward to the completion of the larger clinical validation study later this year."
More than 12 million shares traded hands as the stock traded as high as $7.74 before pulling back and ending the day at $7.19, up 48 cents.
Shares of Marina Biotech, Inc. (NASDAQ:MRNA) took a hit Thursday after the RNAi-based drug discovery and development company, announced the pricing of an public offering of 6.375 million units at a price of $0.80 per unit, for gross proceeds of $5 million. Marina Biotech intends to use the proceeds from this offering for general corporate purposes such as working capital and operational purposes as well as toward the clinical development of CEQ508, which is currently in a Phase 1b/2a clinical trial for the treatment of Familial Adenomatous Polyposis.
Shares of Marina fell 32 cents or 28% to close the day at $0.80.
Echo Therapeutics, Inc. (OTC Bulletin Board:ECTE.ob),soared nearly 40% today after the company announced that its needle-free drug delivery device, the Prelude System, is featured on the Fast Company magazine website.
The article headlined, "New Drug Delivery Device Will Speed Up Numbing, Sans Needle," notes that the Prelude System "promises to speed up the effects of lidocaine, a topical anesthetic, so shots, IVs, and other medical procedures will be less painful."
"We are pleased to have our technology featured by Fast Company magazine and to have Prelude's needle-free drug delivery benefits explained so clearly to its influential readership," stated Patrick T. Mooney, MD, Chairman and CEO of Echo Therapeutics. "Building on the positive momentum we have generated through much hard work, we are excited to increase the visibility of our needle-free platform technology as we near potential FDA marketing clearance."
Shares of ECHO gained $1.33 to $4.72.
Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) and Medicis Pharmaceutical Corporation (NYSE:MRX) today announced that the two companies have entered into a research and development agreement to discover and develop boron-based small molecule compounds directed against a target for the potential treatment of acne.
Under the terms of the agreement, Anacor will receive a $7 million upfront payment from Medicis and will be primarily responsible for discovering and conducting early development of product candidates which utilize Anacor’s proprietary boron chemistry platform. Medicis will have an option to obtain an exclusive license for products covered by the agreement. Anacor will be eligible for future research, development, regulatory and sales milestones of up to $153 million, as well as high single-digit to low double-digit royalties on sales by Medicis. Medicis will be responsible for further development and commercialization of the licensed products on a worldwide basis.
Access Plans, Inc. (OTCBB: APNC) , a leading membership benefits marketing company, today announced its operating results for the first quarter of FY2011.