|Healthcare Review: Egalet, BioTime, Intercept Pharmaceuticals, Exact Sciences, AcelRx Pharmaceuticals|
|By Staff and Wire Reports|
|Tuesday, 12 August 2014 13:49|
The U.S. stock market eased in afternoon trading Tuesday following two days of gains. Investors focused on problems in Ukraine and Iraq.Energy stocks were among the biggest decliners, dragged down by lower oil prices. The Dow Jones industrial average slipped 12 points, or 0.1 percent, to 16,557 as of 1:25 p.m. Eastern time. The Standard & Poor's 500 index fell three points, or 0.2 percent, to 1,934 and the Nasdaq composite fell 13 points, or 0.3 percent, to 4,388.
Egalet ($EGLT) Q2 results: Revenues: $0.5M; Net Loss: ($11.7M) (-216.2%); Loss Per Share: ($0.73) (+74.5%); Quick Assets: $69.3M (+341.4%).Hired new CMO.Egalet-001: received positive results from category 1 abuse deterrent study, announced top-line results from two bioequivalence studies and initiated category 2/3 abuse-deterrent study.
The FDA approves BioTime's ($BTX) Premvia hydrogel for the management of wounds. The Class II device mimics the human body's extracellular matrix by cross-linking collagen and hyaluronic acid. It is the first member of the company's HyStem family of products to achieve regulatory clearance in the U.S.
Shares of Intercept Pharmaceuticals (NASDAQ:ICPT) are up 56% premarket on light volume after the company disclosed positive results in a clinical trial of its lead product candidate.In a Phase 2b trial (10-Q, page 18), called FLINT, the safety and efficacy of obeticholic acid (OCA) was being evaluated for the treatment of nonalcoholic steatohepatitis (NASH). The U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored the study.
The FDA clears Exact Sciences' ($EXAS) Cologuard, a stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancerous or pre-cancerous. Patients who test positive with Cologuard are advised to undergo a diagnostic colonoscopy. Concurrently, the Centers for Medicare & Medicaid Services (CMS) issue proposed coverage guidelines targeting asymptomatic patients aged 50 - 85 years that are average risk of developing colorectal cancer. CMS proposes to cover the cost of the test once every three years.
AcelRx Pharmaceuticals ($ACRX) Q2 results: Revenues: $71K; Net Loss: ($10.6M) (+39.1%); Loss Per Share: ($0.30) (+36.2%); Quick Assets: $92.3M (-11.0%).2014 Guidance: R&D expenses: $27M - 29M; G&A expenses: $21M - 23M; operating expenses: $48M - 52M; quick assets at year end: at least $65M.