|Corgenix Files Pre-Market Notification for Hyaluronic Acid Test Kit; Sarepta Announces NDA Filing for Eteplirsen Premature|
|By Staff and Wire Reports|
|Tuesday, 12 November 2013 19:55|
Corgenix Medical Corporation (OTCBB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, announced today it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for its Hyaluronic Acid (HA) ELISA Test Kit.
The submission follows the completion of a clinical study conducted by Corgenix and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under a cooperative research and development agreement (CRADA).
The study assessed the Corgenix Hyaluronic Acid (HA) Test Kit as a marker for liver fibrosis in nonalcoholic steatohepatitis (NASH) patients. NASH patients are typically diagnosed using invasive liver biopsy procedures. The Corgenix-NIDDK study was focused on developing a non-invasive method of diagnosis.
Nonalcoholic fatty liver disease (NAFLD) is a chronic, typically mild liver condition associated with obesity and insulin resistance, characterized by the presence of fat in the liver. Currently recognized as the most common cause of chronic liver disease in the U.S., NAFLD affects 20-24 percent of Americans. Nonalcoholic steatohepatitis (NASH) is an advanced form of NAFLD associated with inflammation and damage to the liver that can progress to fibrosis and cirrhosis. Approximately two to five percent of the U.S. population has NASH.
The safety and efficacy of the HA Test Kit has not yet been evaluated by the U.S. Food and Drug Administration.
Sarepta Therapeutics (NASDAQ: SRPT) provided an update on its discussions with the U.S. FDA regarding its planned New Drug Application submission and confirmatory clinical study with eteplirsen for the treatment of Duchenne muscular dystrophy. Citing recent developments since Sarepta's last meeting with the agency, including a failed study with a competitive product and recent natural history data in DMD, the FDA indicated the new data raise "considerable doubt" about both the dystrophin biomarker and the supportive clinical efficacy assessed on the 6-minute walk test (6MWT) in the Phase IIb clinical study of eteplirsen. As a result of these recent data, the FDA stated that they "currently consider an NDA filing for eteplirsen as premature."
"We are very disappointed with the FDA's decision to reconsider their openness to a potential NDA filing based on our current data and the resultant impact this change may have on our efforts to achieve an earlier approval of eteplirsen," said Chris Garabedian, president and chief executive officer of Sarepta Therapeutics. "We strongly believe in the potential of eteplirsen to address a serious unmet medical need in DMD and we are committed to its development. Our team at Sarepta recognizes the urgency of families who are seeking new treatments, and we will continue to work with the FDA on an acceptable confirmatory study design and, in parallel, seek to address their concerns regarding a potential NDA filing based on our current dataset." The FDA provided the feedback in pre-meeting comments and clarified them in a meeting with Sarepta that took place late last week to discuss the eteplirsen clinical program.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that Nick Colangelo, President and CEO of Aastrom, will present at the 2013 Therapeutic Area Partnerships Conference on Tuesday, November 19 at 4:30 p.m. EST at the Hyatt Regency in Boston, MA.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today reported financial results for the quarter and nine months ended September 30, 2013.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported financial results for the three and nine months ended September 30, 2013 and provided an update on the Company's portfolio of direct-acting antiviral compounds being developed for the treatment of chronic hepatitis C virus (HCV).
Air Methods Corporation (Nasdaq:AIRM) today announced that its United Rotorcraft Division completed and delivered the first of four medically-equipped Bell 407GX helicopters to CareFlite, a non-profit 501(c) 3 corporation providing medical transport across North Texas.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the third quarter ended September 30, 2013.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and nine months ended September 30, 2013.
Cellular Dynamics International, Inc. (Nasdaq:ICEL), a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today reported financial results for the third quarter ended September 30, 2013.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), a development stage pharmaceutical company focused on the acquisition, development and commercialization of innovative pharmaceutical products, announced today that it plans to offer shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today reported its financial results and business highlights for the third quarter ended September 30, 2013.
DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to therapy and manage side effects arising from cancer treatment, announced today that the NASDAQ Listing Qualifications Staff has granted the company's request for an additional 180-day period in which to regain compliance with the minimum $1.00 bid price per share requirement.
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that the U.S. FDA has cleared the Company's investigational new drug (IND) application for AEROSURF® and the Company can initiate its phase 2 clinical program.
Emisphere Technologies, Inc. (OTCBB:EMIS) today announced its financial results for the quarter ended September 30, 2013.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today details for its 2013 investor meeting, which will be held on November 20, 2013 from 5:30 to 7:00 pm ET at the New York Hilton Midtown.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the third quarter that ended September 30, 2013.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported that five of the eight patients have been enrolled and infused in cohort 1 of its blinded Phase 1 clinical trial of GR-MD-02 for patients with nonalcoholic steatohepatitis (NASH or fatty liver disease) with advanced fibrosis.
Gentium S.p.A. (Nasdaq:GENT) today announced that the medical team from the Phase 1 Trial Unit of the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine ("HUSM"), Fukushima Medical University ("FMU") has successfully completed the phase 1 clinical study to evaluate the Safety and Pharmacokinetics of Defibrotide (DF) in Healthy Adults.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today reported net revenue of $15.5 million during the third quarter of 2013 which includes sales of its newly approved medication, RAVICTI® (glycerol phenylbutyrate) Oral Liquid and the first full quarter of sales of BUPHENYL® (sodium phenylbutyrate) Tablets and Powder following the company's acquisition of that product.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today provided a corporate progress update and reported financial results for the quarter ended September 30, 2013.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate in two investor conferences this week.
MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its financial results for the quarter ended September 30, 2013.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has launched Myriad myPath™ Melanoma, a new diagnostic test to effectively differentiate malignant melanoma from benign pigmented skin lesions.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces that it will host its second Annual Charity Poker Game on Wednesday November 13, 2013 at 7:00 pm, following a Cocktail from 5:30-7:00 pm.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces that one of its competitors, Aker BioMarine AS, has recently requested that the U.S. Patent Office review one of the patents in Neptune's portfolio (U.S. Patent No. 8,383,675).
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the third quarter ended September 30, 2013.
OmniComm Systems, Inc. (OTC:OMCM), one of the fastest growing companies in the Electronic Data Capture (EDC) marketplace, today announced the acquisition of Promasys BV, a privately held Netherlands based company dedicated to the development and marketing of clinical trial software and related services designed specifically for academic research and investigator initiated trials.
Oncothyreon Inc. (NASDAQ: ONTY) today reported financial results for the third quarter ending September 30, 2013.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the quarter ended September 30, 2013.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of a broad range of diseases, today reported financial results for the third quarter and nine months ended September 30, 2013 and provided an update on research and development.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today reported financial results for the third quarter ended September 30, 2013.
SANUWAVE Health, Inc. (OTCBB:SNWV) today reported financial results for the three and nine months ended September 30, 2013 and provided a business update.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended September 30, 2013.
Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing products and services, announced today results for the three-month and nine-month periods ended September 30, 2013.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that Thomas J. Sullivan, President and Chief Executive Officer, is scheduled to present at two upcoming investor conferences.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) today reported its consolidated financial results for the third quarter ended September 30, 2013.