|ACADIA ends collaboration. Exact Sciences presents positive data. After the bell: AMAG Pharma, NuVasive slump|
|By BioMedReports.com Staff|
|Thursday, 28 October 2010 18:55|
After the bell shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) fell more than 21%. After the market close today the company reported financial results for the third quarter and nine months ended September 30, 2010. For the third quarter, AMAG reported total revenue of $16.9 million, including $15.1 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues. Additionally, AMAG today announced a restructuring plan to reduce operating expenses. As of September 30, 2010, the Company’s cash, cash equivalents and investments totaled approximately $308 million.
"As our sales in the dialysis segment have begun to decline at a rate quicker than our growth in the non-dialysis chronic kidney disease (CKD) segment, we have made the difficult decision to restructure our organization," said Brian J.G. Pereira, M.D., president and chief executive officer of AMAG. "Today, we are reducing staff and operating expenses to optimize our use of capital and ensure that we invest wisely for the future of Feraheme and AMAG."
The Company today announced a restructuring that includes an overall reduction in its workforce of 24%, or 68 positions. The majority of this workforce reduction is expected to be completed in the fourth quarter of 2010, with any remaining positions being eliminated during the first half of 2011. As a result of this restructuring, the Company estimates that its cash expenses, on an annualized basis, will be reduced by approximately $12 million, primarily related to a reduction in wages and benefit expenses.
In extended trading, shares of AMAG fell $4.20 or 21.76% to $15.10.
After the market close Thursday, NuVasive, Inc. (NASDAQ:NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today financial results for the quarter ended September 30, 2010.
The company reported Q3 earnings of 46 cents per share which was 4 cents better than the concensus of 42 cents however FY10 EPS guidnace was lowered from $1.50-$1.60 to $1.42-$1.45. In the after hours market shares fell $8.96, more than 24% to $27.65.
Exact Sciences (Nasdaq:EXAS) today presented data showing that its non-invasive Cologuard stool-based (sDNA) screening test detected 64 percent of colorectal pre-cancers and 85 percent of cancers. The study was conducted in collaboration with Mayo Clinic and examined more than 1,100 patient samples. Results were presented at the 2010 Special Conference for Colorectal Cancer: Biology to Therapy held by the American Association for Cancer Research in Philadelphia, PA.
Colorectal cancer is the second leading cancer killer in the United States. It often is considered the most preventable, yet least prevented cancer. Colorectal cancer is highly treatable if found early, but 40 percent of adults age 50 and older have not been screened as recommended.
"This is the first study of an sDNA test to show such promising results in detecting colorectal pre-cancer," said lead investigator David A. Ahlquist, M.D., Mayo Clinic, Rochester, Minn. "Colorectal cancer is a treatable disease if caught early, and this test shows great promise as a potential addition to other available screening tools."
The latest American Cancer Society colorectal cancer screening guidelines include the sDNA form of testing as a recommended screening option. The Cologuard sDNA test works by detecting specific altered DNA sequences in cells that are shed into the stool from pre-cancerous or cancerous polyps. If a DNA abnormality is identified from a patient’s sample, a colonoscopy is required to confirm the results.
Findings from the more than 1,100-patient study showed that Cologuard detected 64 percent of adenomas, or polyps, greater than 1 centimeter (cm) and 85 percent of cancer, at a specificity of 88 percent. Polyps over 1 cm are considered the pre-cancers most likely to progress to cancer. Detection rates did not vary by patients’ age or sex, or by cancer location.
"We are excited about these encouraging results for Cologuard, which may offer an important step in the early detection of this terrible disease," said Kevin T. Conroy, president and chief executive of Exact Sciences.
Cologuard is an investigational device and is not available for sale in the United States. The company plans to begin clinical trials next year.
Shares of EXACT Sciences rose 22 cents prior to the news when the stock was halted. Trading did not resume until the after hours session where the stock fell more than 22% or $1.89 to $6.68. There is speculation that the company might offer shares to raise more capital. In addition, many investors feel that the news was already baked into the stock.
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) today announced that it has entered into an agreement with Biovail Laboratories International SRL ("BLS"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE and TSX: VRX), pursuant to which ACADIA and BLS have agreed to conclude their previously established collaboration to develop and commercialize pimavanserin in the United States and Canada. ACADIA has regained all rights to pimavanserin and will receive a one-time cash payment of $8.75 million from BLS to transition the program back to ACADIA and cover costs associated with ongoing clinical trials. ACADIA will continue to pursue the development of pimavanserin, which is in Phase III clinical trials as a treatment for Parkinson’s disease psychosis (PDP), and will have no future payment obligations to BLS.
"While we have enjoyed a great collaboration with Biovail, both parties recognize that pimavanserin and the broad development strategy at the core of our collaboration were not consistent with the strategic focus of the new Valeant following the recently completed merger," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "With worldwide rights to pimavanserin and a focus on our ongoing Phase III program, we believe ACADIA is positioned on an attractive path forward for this product candidate."
Shares of ACADIA fell 13.70% or $0.12 to $0.76.
Also Thursday:Cellceutix Corporation (PINKSHEETS: CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations.
Cephalon, Inc. (Nasdaq:CEPH) today reported third quarter 2010 sales of $707.1 million, a 32 percent increase compared to sales of $535.2 million for the third quarter 2009.
Champions Biotechnology, Inc. (OTC Bulletin Board:CSBR), a company engaged in the development of advanced preclinical platforms and tumor specific data to enhance the value of oncology drugs, today announced that Mr. Joel Ackerman has joined the management team as the Chief Executive Officer of the Company.
ChromaDex Corporation (OTC Bulletin Board:CDXC), a leader in the development of phytochemical and botanical reference standards and the creation of associated intellectual property, announced today that the Company appointed William F. Spengler to President of the Company, effective November 15, 2010.
Codexis, Inc. (Nasdaq:CDXS) today announced financial results for the third quarter ended September 30, 2010.
CONMED Corporation (NASDAQ: CNMD) today announced financial results for the third quarter of 2010.
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that William F. Daly has joined the company as vice president of business development.
InterMune, Inc. (Nasdaq:ITMN) today announced results from operations for the third quarter and nine months ended September 30, 2010.
MWI Veterinary Supply, Inc. (NASDAQ:MWIV) announced today that the Company will release financial results for its fourth quarter and fiscal year ended September 30, 2010 and provide its business outlook for its fiscal year ending September 30, 2011 on Thursday, November 4, 2010.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) today announced its financial results for the quarter ended September 30, 2010.
NeoGenomics, Inc. (OTC Bulletin Board: NGNM), a leading provider of cancer-focused genetic testing services today reported its results for the third quarter 2010.
NuVasive, Inc. (NASDAQ: NUVA) --Total revenue of $120.3 million, up 27% over third quarter 2009 --GAAP earnings of $8.5 million, or $0.21 per share; Non-GAAP earnings of $18.4 million, or $0.46 per share --Non-GAAP operating margin of 16.6%, up from 15.8% for second quarter 2010.
Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the third quarter ended September 30,2010 on Wednesday, November 3, 2010 after the markets close.
PDI, Inc. (Nasdaq:PDII), a leading provider of integrated promotional outsource services to established and emerging healthcare companies, today announced that it will release its third quarter 2010 financial results on Wednesday, November 3, 2010 before the market open and host a conference call beginning at 10:00 am Eastern time to discuss the results.
Pfizer Inc.(NYSE:PFE) announced today that the Japanese Ministry of Health, Labour and Welfare approved Lyrica® (pregabalin) capsules for the treatment of peripheral neuropathic pain.
PharmAthene, Inc. (NYSE Amex:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today the launch of the RPC Investor Channel -- a new and innovative video website developed to enhance communications and corporate access for key audiences interested in RPC.
As reported earlier today on BioMedReports, Sanofi-aventis (EURONEXT: SAN and NYSE:SNY) and BMP Sunstone Corporation (Nasdaq: BJGP) announced today that they have entered into a definitive agreement under which sanofi-aventis is to acquire all outstanding shares of BMP Sunstone for cash consideration of USD 10 per share, or a total of approximately USD 520.6 million on a fully diluted basis.
Sequenom, Inc. (Nasdaq:SQNM) today announced that data from a number of research activities will be highlighted at the 60th Annual Scientific meeting of the American Society of Human Genetics, being held November 2-6, 2010 in Washington DC.
Shire plc (LSE: SHP, Nasdaq:SHPGY), the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV™ (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, today announced that the Company is expanding its generic drug distribution within the emerging pharmaceutical markets in Mexico and Latin America.
Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) today announced its financial results for the three and nine months ended September 30, 2010 and filed its Quarterly Report on Form 10-Q with the U.S. Securities and Exchange Commission (SEC).
Unity Management Group, Inc. (PINKSHEETS:UYMG), a Health Resource Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies, today announced that the First Issue of its monthly e-Newsletter for all subscribing shareholders and investors will be launched Wednesday, November 10.
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced it will release results for the third quarter of 2010, on Wednesday, November 3, 2010, before the market opens.
XTend Medical, (PINKSHEETS: XMDC), a company that specializes in delivering life changing medical technology to healthcare organizations globally, announced today that the company will soon be launching a new website within the next few weeks.