New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 2, 2013
09:02 EDTBAX, HALOBaxter submits amended BLA to U.S. FDA for HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that Baxter has completed submission of an amended biologics license application to the United States Food and Drug Administration to re-initiate the review process for approval of HyQvia facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency. HyQvia is a combination of human immune globulin and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period. The original BLA submission for HyQvia was based on results from a Phase III, prospective, open-label, non-controlled multi-center clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, rate of adverse reactions and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions for patients who received HyQvia were local infusion site reactions and headache, nausea, fatigue and fever. HyQvia was approved and launched in a number of European countries in the second half of 2013.
News For BAX;HALO From The Last 14 Days
Check below for free stories on BAX;HALO the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
April 17, 2014
07:04 EDTBAXBaxter reports Q1 BioScience revenue $1.61B
Reports Q1 Medical Products sales $2.34B.
07:03 EDTBAXBaxter sees Q2 EPS before special items $1.18-$1.22, consensus $1.28
Subscribe for More Information
07:03 EDTBAXBaxter sees FY14 EPS before special items $5.05-$5.25, consensus $5.13
Sees FY14 sales growth 9%-10%, before the impact of foreign exchange, consensus $16.6B. Sees FY cash flow from operations approx. $3.5B.
07:01 EDTBAXBaxter reports Q1 adjusted EPS $1.19, consensus $1.09
Subscribe for More Information
April 16, 2014
08:48 EDTBAXBaxter says meets primary endpoint in Phase 3 BAX 111 trial
Subscribe for More Information
April 15, 2014
10:00 EDTHALOOn The Fly: Analyst Initiation Summary
Allscripts (MDRX) reinstated with an Outperform at Raymond James... Amber Road (AMBR) initiated with a Buy at Canaccord... Autonation (AN) coverage assumed with a Market Perform at Wells Fargo... BG Group (BRGYY) initiated with an Outperform at BMO Capital... Borderfree (BRDR) initiated with a Buy at Canaccord... Dean Foods (DF) initiated with a Buy at BB&T... Destination XL (DXLG) initiated with a Buy at Ascendiant... Group 1 Automotive (GPI) coverage assumed with a Market Perform at Wells Fargo... Halozyme (HALO) initiated with a Buy at Citigroup... MakeMyTrip (MMYT) initiated with a Neutral at Goldman... Penske Automotive (PAG) coverage assumed with a Market Perform at Wells Fargo... RPM (RPM) initiated with an Outperform at Wells Fargo... RSP Permian (RSPP) initiated with a Buy at KLR Group... Repligen (RGEN) initiated with a Buy at Jefferies... Spansion (CODE) initiated with a Buy at Sterne Agee... Statoil (STO) initiated with a Market Perform at BMO Capital... TPG Specialty Lending (TSLX) initiated with a Buy at BofA/Merrill... Versartis (VSAR) initiated with a Buy at Citigroup... WWE (WWE) initiated with a Buy at Needham... WebMD (WBMD) reinstated with a Strong Buy at Raymond James.
09:16 EDTHALOOn The Fly: Pre-market Movers
Subscribe for More Information
09:00 EDTHALOHalozyme rises 8.6%
Subscribe for More Information
05:42 EDTHALOHalozyme initiated with a Buy at Citigroup
Subscribe for More Information
April 9, 2014
08:09 EDTHALOHalozyme's PEGPH20 pancreatic cancer trial placed on hold
Subscribe for More Information
April 8, 2014
07:22 EDTBAXCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 4, 2014
16:30 EDTHALOOn The Fly: Closing Wrap
Subscribe for More Information
12:09 EDTHALOOn The Fly: Midday Wrap
Subscribe for More Information
12:00 EDTHALOHalozyme falls 27.5%
Subscribe for More Information
10:00 EDTHALOHalozyme falls 24.4%
Subscribe for More Information
09:37 EDTHALOHalozyme defended after halt of Phase 2 trial enrollment at Piper Jaffray
Subscribe for More Information
09:13 EDTHALOOn The Fly: Pre-market Movers
HIGHER: Mylan (MYL), up 6.8% after report of desire to buy Swedish rival Meda, which confirmed it had been in talks with Mylan but rejected the company's takeover offer. Shares of Mylan were also upgraded to Buy this morning at Citigroup... Mercury Systems (MRCY), up 8.8% after Reuters said Boeing (BA) is considering a takeover bid of the supplier..Micron (MU), up 3% after reporting earnings and revenue that topped expectations... Align (ALGN), up 6% after winning patent case against ClearCorrect... GameStop (GME), up 2.8% following upgrade at BofA Merrill Lynch... Potbelly (PBPB), up 4.6% after upgrade at William Blair.... SYNNEX (SNX), up 18.5% after earnings report. LOWER: CarMax (KMX), down 3.3% after reporting earnings and revenue that fell below expectations... Halozyme (HALO), down 33% after announcing temporary halt of Phase 2 trial enrollment for PEGPH20... Ocean Power (OPTT), down 15% after 3.8M share Spot Secondary priced at $3.10.
09:07 EDTHALOHalozyme volatility elevated into temporary halt of Phase 2 trial enrollment
Halozyme volatility is expected to move after announces temporary halt of Phase 2 trial enrollment for PEGPH20. Overall option implied volatility of 89 is above its 26-week average of 72 according to Track Data, suggesting large price movement.
09:00 EDTHALOHalozyme falls 31%
Halozyme is down 31%, or $3.59, to $8.00
08:03 EDTHALOHalozyme announces temporary halt of Phase 2 trial enrollment for PEGPH20
Subscribe for More Information
1 | 2 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use