Shares of Hologic, Inc. (NASDAQ:HOLX) ended Friday session in red amid volatile trading. The shares closed down -1.34 points or -3.48% at $37.16 with 2.36 million shares getting traded. Post opening the session at $38.27, the shares hit an intraday low of $37.16 and an intraday high of $38.38 and the price vacillated in this range throughout the day. The company has a market cap of $9.95 billion and the numbers of outstanding shares have been calculated to be 277.42 million shares.
Hologic, Inc. (HOLX) on Sept. 8, 2016 announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for the company’s Aptima® Zika virus diagnostic assay to be used with urine samples (collected alongside patient-matched serum or plasma specimens).
Hologic’s Zika virus assay was authorized for emergency use with serum and plasma (blood) samples in June 2016. Its new use with urine samples lengthens the time period during which patients can be tested for Zika from seven days to 14 days following symptoms, as recommended by the U.S. Centers for Disease Control and Prevention (CDC).
“This action by FDA is significant because it gives many more people the opportunity to be tested with our highly sensitive assay,” said Tom West, Division President of Diagnostic Solutions at Hologic. “In particular, this expanded indication allows us to better serve public health labs, increasing access to more people to detect and diagnose more disease.”
The Aptima Zika Virus assay runs on Hologic’s Panther® system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. By reducing hands-on time, the Panther system helps to minimize labor needs and the potential for manual errors. The Aptima Zika Virus assay is available for use in all 50 states, Puerto Rico and U.S. territories.
“We are driven to provide solutions to some of society’s most urgent unmet health needs,” said Steve MacMillan, Chairman, President and Chief Executive Officer of Hologic. “The suspension of the Medical Device Excise Tax enabled us to make additional investments in research and development and accelerate availability of this critically important test.”
Shares of Sanofi SA (ADR) (NYSE:SNY) ended Friday session in red amid volatile trading. The shares closed down -0.90 points or -2.24% at $39.19 with 2,354,721 shares getting traded. Post opening the session at $39.67, the shares hit an intraday low of $39.19 and an intraday high of $39.68 and the price vacillated in this range throughout the day. The company has a market cap of $99.80 billion and the numbers of outstanding shares have been calculated to be 1.29 billion shares.
On Aug. 29, 2016 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced detailed positive results from ODYSSEY ESCAPE, a Phase 3 trial which evaluated Praluent® (alirocumab) Injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) who require regular weekly or bi-weekly apheresis treatment. The trial demonstrated that adding Praluent to existing therapy reduced LDL cholesterol by approximately 50 percent from baseline (compared to 2 percent increase for placebo). Praluent significantly reduced the need for apheresis treatment by 75 percent compared to placebo (p less than 0.0001), the primary endpoint of the study.
Apheresis is a procedure similar to kidney dialysis where bad (LDL) cholesterol is removed from the blood, and is usually reserved for high-risk patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy. Despite being treated with apheresis and entering ODYSSEY ESCAPE with very high LDL cholesterol levels (4.7 millimoles/liter [mmol/L] or 181 milligrams/deciliter [mg/dL]), nearly two-thirds (63 percent) of patients treated with Praluent no longer required apheresis therapy after six weeks of receiving Praluent. At this same time point, the average LDL cholesterol level among the Praluent-treated group was 2.3 mmol/L (90 mg/dL), compared to 4.8 mmol/L (185 mg/dL) in the placebo group. European guidelines recommend LDL cholesterol target levels between 1.8-3.0 mmol/L (70-115 mg/dL), depending on cardiovascular risk.
“Findings from ODYSSEY ESCAPE suggest a role for Praluent in the overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to reduce the need for burdensome apheresis treatments,” said Patrick M Moriarty, MD, Professor, Department of Internal Medicine; Director, Atherosclerosis and Lipoprotein Apheresis Center, University of Kansas Medical Center, United States. “This is a significant development in the continued investigation of this drug in HeFH patients, because it is the first clinical trial to demonstrate that Praluent reduced the frequency of apheresis therapy.”