|MELA soars on amended PMA. Breast reconstruction trial results boost shares of Cytori. GTx ends partnership, shares fall. After the bell: OPKO announces offering|
|By BioMedReports.com Staff|
|Wednesday, 02 March 2011 19:43|
After the bell, OPKO Health, Inc. (NYSE Amex: OPK) announced that it intends to offer and sell $100 million of its common stock in an underwritten public offering. Shares fell 40 cents or 9% to $4.20.
Shares of MELA Sciences (NASDAQ:MELA) soared today after the company announced that it has filed an amendment to the MelaFind pre-market approval (PMA) application with the U.S. Food and Drug Administration, limiting the indication for use to dermatologists.
"We have clarified the intended use of MelaFind to dermatologists as a response to public statements made by several dermatologists sitting on the November 18, 2010 MelaFind FDA review panel," said Joseph Gulfo, MD, President and CEO, MELA Sciences. "We look forward to working with the Agency to move the MelaFind PMA application forward. On a parallel track, we are seeking to obtain a CE Mark for MelaFind from European regulatory authorities and hope to receive it in the second half of this year."
Shares of MELA jumped 52 cents or 20% to $3.07.
Cytori Therapeutics (NASDAQ:CYTX), climbed higher today after results from a European breast reconstruction trial using a new minimally invasive procedure to repair lumpectomy defects resulted in a sustained and substantial rate of physician and patient satisfaction at 12 months. The study utilized the regenerative cells in the patient's own fat tissue, extracted at the time of the procedure using the Celution 800/CRS System. The cells were then mixed back with a portion of the patient's own body fat, and this mixture of fat and cells was injected into the breast defect. Specifically, 12 month physician satisfaction was 85% and patient satisfaction 75%, which is consistent with reported six month results.
"We believe cancer treatment is incomplete without reconstruction," said Marc H. Hedrick, M.D., president of Cytori Therapeutics. "The RESTORE procedure has the potential to become the gold standard for lumpectomy defect repair, even in the context of radiation scarring, for which there is no accepted standard-of-care. The data from the study strengthens the long-term safety profile of this treatment and soundly shows efficacy in breast cancer patients."
On heavy volume, shares of Cytori gained 52 cents, more than 9% to $6.13. Earlier in the session, shares traded as high as $6.69.
GTx, Inc. (Nasdaq:GTXI) sank today after the company and drug maker Ipsen Ltd. mutually agreed to terminate their collaboration for the development and commercialization of the bone drug toremifene. Projected costs in the second Phase III clinical trial have exceeded the amount stipulated in the collaboration agreement between the two companies, leading to the termination. Under the termination agreement, Ipsen will receive royalties on future sales of toremifene 80-milligram in the U.S. should the drug achieve regulatory approval.
In October 2009, GTx received a CRL from the FDA that the drug would not be approved in its present from due to certain clinical deficiencies. The drug is being developed to reduce bone fractures in men who have prostate cancer and are being treated with androgen deprivation therapy, which can weaken bones.
GTx dropped 27 cents or 10.5% to $2.31.
Celsion Corporation (NASDAQ:CLSN), today announced that the European Commission has granted orphan drug designation for the Company's lead compound, ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. ThermoDox, which also holds orphan drug designation in the U.S., is currently being evaluated under a Special Protocol Assessment with the U.S. Food and Drug Administration in a 600 patient pivotal Phase III trial, the HEAT study, in patients with non-resectable primary liver cancer.
Marina Biotech, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, reported data demonstrating significant knockdown of target mRNA in an orthotopic model of malignant ascites with its proprietary UsiRNA construct and DiLA2-based delivery system.
Omeros Corporation (Nasdaq:OMER) today announced that it has identified compounds that interact selectively with two orphan G protein-coupled receptors (GPCRs) linked to pancreatic cancer (GPR182) and cognitive disorders (GPR12). Together with the three previously unlocked orphans linked to squamous cell carcinoma (GPR87), obesity (GPR85) and appetite control (GPR101), Omeros has now successfully unlocked five orphan GPCRs.
Adherex Technologies Inc. (PINK SHEETS:ADHXF) , a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, intends to commence its previously disclosed rights offering, today, March 2nd, at 5:00 pm New York City time, the record date for the rights offering.
ALR Technologies Inc. (OTCBB: ALRT) announces that on February 28, 2011 the Company submitted its reply to questions asked by the FDA in response to the company's 510(k) application that was originally submitted to FDA on July 23, 2010 for its proprietary Health-e-Connect (HeC) System.