MELA soars on amended PMA. Breast reconstruction trial results boost shares of Cytori. GTx ends partnership, shares fall. After the bell: OPKO announces offering Print E-mail
By Staff   
Wednesday, 02 March 2011 19:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 02, 2011.

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.

Earlier Wednesday:

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.

"Ipsen has been an excellent and supportive partner," said Dr. Mitchell S. Steiner, MD, CEO of GTx. "We spent significant time analyzing the business case for toremifene 80 mg and have concluded that the most appropriate course is to terminate our collaboration."

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.

Also Wednesday:

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.

BAETA Corp. (OTCBB: BAEA), an advanced technology-enabled health improvement company, announces that Dr. Michael Semenovski has joined BAETA Corp. as the Chief Medical Officer and becomes a member of the Company's management team.

Cadence Pharmaceuticals, Inc. (Nasdaq:CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that the company's President and CEO Ted Schroeder will present the company's corporate overview on Wednesday, March 9, 2011 at 8:00am Eastern Time (5:00am Pacific Time) during the Cowen and Company 31st Annual Health Care Conference at the Boston Marriott Copley Place Hotel in Boston.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced that Caldolor® (ibuprofen) Injection is being used by anesthesiologists in a growing number of hospitals and surgery centers to provide preemptive analgesia for surgical patients.

DURECT Corporation (Nasdaq:DRRX) announced today financial results for the three months and year ended December 31, 2010.

Herborium Group, Inc., (PINKSHEETS: HBRM), a Botanical Therapeutics™ company, today announced that it has been selected to provide the editorial on alternative acne treatment for National Association of Primary Care (NAPC) Review, Spring 2011 edition.

IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shoham today issued an update on their marketing representative in South Africa.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it achieved compelling results in a study of its DNA vaccine for foot-and-mouth disease administered by Inovio's proprietary vaccine delivery technology.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, and GlaxoSmithKline Inc., one of the world's leading research-based pharmaceutical and healthcare companies, today announced an exclusive distribution agreement for the OmniPod Insulin Management System in Canada.

Lixte Biotechnology Holdings (OTC: LIXT) announced today that the company has received a $244,479.25 grant under the Qualifying Therapeutic Discovery Project (QTDP). This grant was awarded to further development and commercialization of Lixte's novel anti-cancer compound LB-100.

Luminex Corporation (Nasdaq:LMNX) today announced that senior management will present at the 31st Annual Health Care Conference to be held March 7 -9, 2011, in Boston, MA.

Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that, on March 1, 2011, the Company received a positive determination from the NASDAQ Listing Qualifications Panel indicating that the Panel had granted the Company's request for an extension to remain listed on The NASDAQ Stock Market ("NASDAQ").

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Cowen & Co. 31st Annual Health Care Conference in Boston.

OmniComm Systems, Inc. (OTC Bulletin Board:OMCM), one of the fastest growing companies in the EDC marketplace, today announced that its TrialOne suite of applications has been chosen by West Coast Clinical Trials (WCCT) to automate their clinical trial operations and processes within their early-phase clinics.

Pharmacyclics, Inc. (Nasdaq:PCYC) today announced that further advancement of PCI-45292, a Btk inhibitor with exceptionally potent anti-arthritis activity in mice and rats, has been suspended following results from the current set of preclinical toxicology studies.

SciMeDent Health, Corp. f/k/a Trend Exploration, Inc. (PINKSHEETS: TRDX) is pleased to announce Preferred Distribution, Inc., its medical/dental supplies distribution subsidiary, has recently been approved as a distributor for Bellco, a regional pharmaceutical wholesaler of over 20,000 branded and generic products, including pharmaceuticals, OTC, and health & beauty products.

ShangPharma Corporation (NYSE:SHP) , a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it will release its unaudited financial results for the fourth quarter and full year 2010 ended December 31, 2010 on March 15, 2011.


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