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Stock Market & Financial Investment News

News Breaks
July 31, 2014
14:41 EDTLMNX, DGX, LH, PACB, ILMN, VCYT, SQNM, QGEN, MYGN, GHDXFDA draft lab tests guidelines not as bad as feared, says Piper Jaffray
After the FDA announced it intends to issue draft guidance on regulations for lab developed tests, Piper Jaffray said the proposed guidelines appear "less onerous" than the firm initially expected. Piper added that the FDA intends to leverage existing studies in lieu of requiring additional studies, which the firm views as positive for companies with well validated offerings such as Genomic Health (GHDX), Myriad Genetics (MYGN), QIAGEN (QGEN), Sequenom (SQNM), and Veracyte (VCYT).
News For GHDX;MYGN;QGEN;SQNM;VCYT;DGX;ILMN;LH;LMNX;PACB From The Last 14 Days
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December 19, 2014
12:12 EDTMYGNMyriad Genetics receives FDA approval of BRACAnalysis CDx
Myriad Genetics (MYGN) announced that it has received approval from the U.S. FDA for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's (AZN) drug Lynparza. Lynparza is the first poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor. BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad's commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.
10:17 EDTMYGN, GHDXOn The Fly: Analyst Initiation Summary
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07:15 EDTMYGNMyriad Genetics initiated with a Market Perform at Wells Fargo
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07:15 EDTGHDXGenomic Health initiated with a Market Perform at Wells Fargo
Price target range $33-$35.
December 18, 2014
09:07 EDTLHLabCorp announces availability of test to identify enterovirus D-68
LabCorp announced the availability of a reflex test to identify enterovirus D68, which is associated with severe respiratory illness that primarily affects children. The EV-D68 PCR test determines the presence or absence of enteroviral RNA in a respiratory sample, and if positive, reflexes to an EV-D68-specific PCR test. The EV-D68 subtyping PCR test enables the presence or absence of the predominant D68 strain to be determined.
08:05 EDTGHDXGenomic Health apoints Patrick F. Terry as Chief Commercial Officer
Claritas Genomics appointed Patrick F. Terry to the role of Chief Commercial Officer. Terry has been involved in shepherding multiple biotechnology products through commercial development to clinical delivery.
06:21 EDTQGENQIAGEN downgraded to Sell from Neutral at Goldman
Goldman downgraded QIAGEN to Sell based on a mixed growth outlook for new products and the dilutive impact on the core franchise value from M&A. Price target lowered to $19 from $21.
06:18 EDTDGXRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 17, 2014
10:21 EDTMYGNMyriad denied appeal to block competing breast cancer tests, Bloombeg reports
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December 16, 2014
08:46 EDTLHLabCorp, Covance announce expiration of Hart-Scott-Rodino waiting period
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December 15, 2014
10:10 EDTLHHigh option volume stocks:
High option volume stocks: RVBD AGCO FRO CRUS UBNT LH PAY PETM OREX KOS
December 11, 2014
12:54 EDTMYGNMyriad Genetics management to meet with William Blair
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December 10, 2014
08:06 EDTGHDXGenomic Health presents first results of Oncotype DX breast cancer test
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December 9, 2014
15:31 EDTLHLabCorp management to meet with Craig-Hallum
Meeting to be held in Baltimore on December 10 hosted by Craig-Hallum.
09:03 EDTGHDXGenomic Health advances development of novel liquid biopsy-based cancer tests
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07:44 EDTDGXAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
07:26 EDTGHDX, VCYTLeerink to hold a tour
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