Shares of Abbott Laboratories (NYSE:ABT) ended Monday session in green amid volatile trading. The shares closed up 0.13 points or 0.32% at $40.50.As Abbott to Present at Barclays Capital 2016 Global Healthcare Conference.
Abbott (ABT) will present at the Barclays Capital 2016 Global Healthcare Conference on Thursday, March 17, 2016. Brian Yoor, senior vice president, finance and chief financial officer, will present at 9:15 a.m. Central time.
Abbott Laboratories manufactures and sells health care products worldwide. The companys Established Pharmaceutical Products segment offers branded generic pharmaceuticals to treat pancreatic exocrine insufficiency; irritable bowel syndrome or biliary spasm; intrahepatic cholestasis or depressive symptoms; gynecological disorders; hormone replacement therapy; dyslipidemia; hypertension; hypothyroidism; Ménière’s disease and vestibular vertigo; pain, fever, and inflammation; migraines; anti-infective clarithromycin; and influenza vaccines, as well as to regulate physiological rhythm of the colon. Its Diagnostic Products segment provides immunoassay and clinical chemistry systems; assays used to screen and/or diagnosis cancer, cardiac, drugs of abuse, fertility, infectious diseases, and therapeutic drug monitoring; hematology systems and reagents; diagnostic systems and cartridges; instruments that automate the extraction, purification, and preparation of DNA and RNA from patient samples, and detects and measures infectious agents; genomic-based tests; informatics and automation solutions; and instrument used to identify infection-causing pathogens.
Shares of UniQure N.V. (NASDAQ:QURE) ended Wednesday session in red amid volatile trading. The shares closed down -0.09 points or -0.68% at $13.13.As uniQure declared dosing of first patient in high-dose cohort in phase I/II hemophilia B clinical trial.
uniQure N.V. (QURE), a leader in human gene therapy, on Monday, declared that the Company has treated the first patient in the second cohort of its ongoing AMT-060-01 Phase I/II trial in hemophilia B patients. The primary objective of the second cohort is to assess the safety of the systemic administration of a higher dose of uniQure’s AMT-060 gene therapy in hemophilia B patients that present with a severe or moderately-severe disease phenotype. Secondary objectives of the trial include evaluation of Factor IX (FIX) activity levels as well as evaluation of annualized bleeding rates and recombinant FIX usage.
The Company declared preliminary top-line results of the low-dose cohort on January 7th, 2016, showing that AMT-060 was generally well tolerated. Additionally, the first two patients that had completed at least 12 weeks of follow-up showed promising increases in FIX expression levels of 5.5% and 4.5% of normal as of the December 16, 2015 cutoff date, and in four of the five patients dosed the need for continuous, prophylactic rFIX treatment was eliminated as of January 6th, 2016. Including the patients screened and treated in the low-dose cohort, a total of eight patients screened to date for the trial have tested negative for pre-existing anti-AAV5 antibodies. uniQure intends to present an updated analysis of all patients in the low-dose cohort at a scientific conference in the second quarter of 2016.
“Our goal for the second cohort is to evaluate AMT-060’s safety profile at a higher dose and to test our hypothesis that with this dose we could achieve further increases in FIX expression levels,” said Deya Corzo, Senior Vice President and Therapeutic Area Head, Liver/Metabolism. “The early data we announced in January indicate that our proprietary AAV5 viral vector can achieve a clinically relevant level of expression of the FIX transgene. Our data thereby reproduced previously published long-term FIX expression levels seen with a dose comparable to that used in our low-dose cohort with the same gene cassette but using a different vector.”
“The successful dosing of the first patient in the high-dose cohort marks another significant step towards bringing this gene therapy to patients,” said Dan Soland, CEO of uniQure. “With the greenlight from the Data Monitoring Committee after the first cohort, we are excited to be able to move the program forward. We strongly believe that the product profile of AMT-060 has the potential to improve the quality of life of hemophilia B patients.”
The AMT-060-01 Phase I/II study is a 5-year, open-label, uncontrolled, dose-ascending trial that includes two cohorts, with the low-dose cohort using a treatment of 5×1012 gc/kg and the high-dose cohort using 2×1013 gc/kg. AMT-060 consists of a codon-optimized wild type FIX gene and the LP1 liver promoter together with the AAV5 viral vector, manufactured using uniQure’s proprietary insect cell based manufacturing technology. It is administered, without immunosuppressant therapy, through the peripheral vein in a single treatment session for approximately 30 minutes. All patients are screened for pre-existing AAV5 antibodies before treatment and Data Monitoring Committee (DMC) reviews are conducted after each of the first 2 patients in the second cohort.
uniQure N.V., a biopharmaceutical company, develops adeno-associated virus (AAV) based gene therapies through its technology platform for multiple therapeutic areas.
Shares of Sequenom Inc. (NASDAQ:SQNM) ended Monday session in green amid volatile trading. The shares closed up 0.02 points or 1.29% at $1.57.
Sequenom, Inc., a life sciences company, develops and commercializes molecular diagnostics testing services for the women’s health and oncology markets in the United States and internationally. The company provides molecular based laboratory developed tests (LDTs) comprising MaterniT21 PLUS LDT, a noninvasive prenatal test (NIPT) to detect fetal chromosomal abnormalities; HerediT CF LDT, a carrier screen test to identify individuals with cystic fibrosis or genetic mutations; SensiGene fetal Rhesus D (RhD) LDT, a NIPT to determine the presence or absence of RhD factor by direct detection of the fetal RhD genotype in RhD negative mothers from a maternal blood sample; and VisibiliT LDT, a NIPT to detect fetal chromosomal abnormalities by determining the relative amount of chromosomal material present in circulating cell-free DNA in a maternal blood sample. It also offers a microarray test that uses fetal samples obtained by amniocentesis or chorionic villus sampling under the NextView brand; additional carrier screening tests for Ashkenazi Jewish disorders, spinal muscular atrophy, and fragile X syndrome under the HerediT brand; and RetnaGene age-related macular degeneration (AMD) test to predict the risk of a patient with dry or early stage AMD progressing to wet or advanced choroidal neovascular disease within 2, 5, and 10 years.