|Aoxing Declines To Comment On Market Activity; Cornerstone Provides Update on Lixivaptan|
|By Staff and Wire Reports|
|Thursday, 13 September 2012 18:55|
Aoxing Pharmaceutical Company, Inc. (NYSE:AXN) in view of the unusual activity today in the market for the common stock of Aoxing Pharmaceutical Company, Inc., the NYSE Euronext has contacted the company in accordance with the Exchange's usual practice. The company stated that its policy is not to comment on unusual market activity.
Cornerstone Therapeutics Inc. (CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, announced today the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) recommended against the approval of the Company's New Drug Application (NDA) for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively.
In March 2012, Cornerstone announced the FDA's acceptance of the Company's NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012. The FDA takes the advisory committee's advice into consideration as part of its review of the NDA but is not bound by the committee's recommendations.
"While we respect the views of the CRDAC, we view today as another step in the process of bringing lixivaptan to market for patients with hyponatremia using the established surrogate endpoint of serum sodium correction," said Craig A. Collard, Cornerstone's Chief Executive Officer. "Cornerstone is committed to continuing to work with the FDA throughout the approval process building upon meeting our primary endpoint in each pivotal Phase 3 trial."
Hyponatremia affects up to six million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually. Lixivaptan is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. Lixivaptan acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
Abbott (NYSE: ABT) announced today that it was included on both the Dow Jones Sustainability World Index and North America Index for the eighth consecutive year.
Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that it has retained the services of Benning Associates, LLC, a Boston based boutique investment bank, to assist in exploring the Company's strategic alternatives.
Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) today announced the appointment of Mr. Mark Ostrowski as Senior Vice President Sales & Marketing Molecular Diagnostics.
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced the availability of XTANDI® (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Neuralstem, Inc. (NYSE MKT: CUR) announced today its intention, subject to market and other conditions, to commence a public offering of its common stock.
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) today announced that its management team will be meeting with investors to review its portfolio of novel drug candidates and the recent positive clinical data from the company's Phase II trial in second-line non-small cell lung cancer, as part of the 3rd Annual Credit Suisse 2012 Small & Mid Cap Conference.
Quick-Med Technologies, Inc. (OTCQB: QMDT), a life sciences company focused on developing antimicrobial technologies for healthcare and consumer markets, announced today that the US Patent and Trademark Office has issued a notice of allowance for a patent protecting Stay Fresh®, Quick-Med's revolutionary new antimicrobial technology.
Sarepta Therapeutics (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, announced today that it is scheduled to present at the 2012 UBS Global Life Sciences Conference in New York, NY on Thursday, September 20, 2012 at 4:00 p.m. Eastern Time.