New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 2, 2013
07:05 EDTIDIX, GILDIdenix files patent infringement, interference lawsuits against Gilead
Idenix Pharmaceuticals (IDIX) announced that it has filed two lawsuits against Gilead Sciences (GILD): a patent infringement lawsuit in the United States District Court in Boston, Massachusetts and a separate patent infringement and interference lawsuit in the United States District Court in Wilmington, Delaware. The Massachusetts infringement lawsuit alleges that Gilead infringes two U.S. patents co-owned by Idenix that cover methods of treating the hepatitis C virus using 2'-methyl nucleosides. In this lawsuit, Idenix is seeking a declaration that Gilead's imminent distribution, importation, use, sale or offer to sell drugs containing sofosbuvir, a 2'-methyl nucleoside compound, infringes Idenix's patents. The Delaware infringement and interference lawsuit alleges that Gilead infringes a separate U.S. patent co-owned by Idenix that covers methods of treating the hepatitis C virus using 2'-methyl-2'-fluoro nucleosides. Idenix is seeking a declaration that Gilead's imminent distribution, importation, use, sale or offer to sell drugs containing sofosbuvir infringes the Idenix '600 patent. Additionally, the Delaware lawsuit asserts a claim for interfering patents between the Idenix '600 patent and a U.S. patent owned by a Gilead subsidiary, Gilead Pharmasset. Idenix is seeking to have the Gilead '322 patent declared invalid.
News For IDIX;GILD From The Last 14 Days
Check below for free stories on IDIX;GILD 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 11, 2014
05:25 EDTGILDGilead announces 95% virologic suppression in HCV study
Gilead Sciences announced data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi 400 mg was administered for the treatment of chronic hepatitis C virus infection in patients with advanced liver disease. The first study, Study GS-US-334-0125, is an ongoing open-label Phase 2 clinical trial evaluating HCV patients with cirrhosis and portal hypertension, with or without decompensation, who were randomized 1:1 to an immediate treatment arm in which Sovaldi and ribavirin was administered for 48 weeks or to a deferred treatment arm in which this regimen was initiated after a 24-week observation period. Eighty percent of participants were treatment-experienced. Of the 22 patients who completed 24 weeks of therapy, 95% achieved virologic suppression on treatment. Additionally, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm. Sovaldi-based therapy was well tolerated in the study, and only one patient discontinued treatment due to an adverse event. The most common adverse events occurring in more than 25 percent of patients included nausea and pruritis.
April 10, 2014
13:12 EDTGILDGilead volatility increases on wide price movement
Subscribe for More Information
11:44 EDTGILDStocks with call strike movement; PCLN GILD
Subscribe for More Information
11:42 EDTGILDReport claims Tamiflu, Relenza do little to prevent the spread of flu
Subscribe for More Information
07:24 EDTGILDInternational Society for Heart & Lung Transplantation to hold annual meeting
Subscribe for More Information
05:37 EDTGILDGilead announces Phase 2 results for investigational sofosbuvir-based regimens
Gilead Sciences announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, for the treatment of chronic hepatitis C virus, or HCV, infection. The first study, ELECTRON2, is an ongoing, open-label Phase 2 clinical trial evaluating a once-daily fixed-dose combination of SOF 400 mg and the NS5A inhibitor ledipasvir, or LDV, 90 mg, with and without ribavirin, or RBV, twice-daily, among HCV-infected patient populations. In this study, 100% of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF plus RBV and 64% of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy. Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100% achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65% of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV was well-tolerated, including among patients with more advanced liver disease. A second study, Study GS-US-342-0102, is an ongoing randomized Phase 2 clinical trial in which treatment-naïve, non-cirrhotic patients with genotypes 1-6 HCV infection received a 12-week course of SOF plus the pan-genotypic NS5A inhibitor GS-5816. Patients received SOF 400 mg and either GS-5816 25 mg or GS-5816 100 mg. In this study, 94.8% of patients receiving the 25 mg dose of GS-5816 and 96.1% of patients receiving the 100 mg dose achieved SVR12.
05:32 EDTGILDGilead announces results from study of Sovaldi
Subscribe for More Information
April 9, 2014
16:00 EDTGILDOptions Update; April 9, 2014
Subscribe for More Information
11:51 EDTGILDStocks with call strike movement; AAL GILD
American Airlines (ALL) August 44 call option implied volatility increased 4% to 39, Gilead (GILD) August 80 call option implied volatility decreased 2% to 34 according to IVolatility.
11:43 EDTGILDGilead defended by analysts after recent pullback
Subscribe for More Information
09:36 EDTGILDActive equity options trading on open
Subscribe for More Information
08:41 EDTGILDAttack on Gilead Sovaldi by Express Scripts 'noise,' says Maxim
After Bloomberg reported that Express Scripts (ESRX) said that it would attempt to build a coalition against the use of Gilead's (GILD) Sovaldi once a rival drug is approved, Maxim views Express Scripts' statement as "noise." The firm says that Sovaldi is not the most expensive HCV drug, and reiterates its view that Sovaldi provides "compelling" value, when including the cost of failure rates in a cost/benefit analysis. Maxim keeps a Buy rating on Gilead.
07:56 EDTGILDGilead poised for strong earnings, says RW Baird
Subscribe for More Information
07:23 EDTIDIX, GILDEuropean Association for the Study of the Liver to hold annual meeting
Subscribe for More Information
April 8, 2014
11:47 EDTIDIXIdenix price target raised to $9 from $6 at Leerink
Leerink raised Idenix's price target to $9 from $6 citing positive IDX21437 data.
April 7, 2014
16:28 EDTIDIXOn The Fly: Closing Wrap
Subscribe for More Information
13:31 EDTIDIXIdenix risk/reward remains favorable, says UBS
UBS said Idenix's IDX21437 update this morning supports its favorable risk/reward thesis. Shares are Buy rated with an $11 price target.
09:34 EDTGILDActive equity options trading on open
Subscribe for More Information
08:31 EDTGILDGilead announecs FDA priority review designation for Ledipasvir/Sofosbuvir
Gilead Sciences announced that the U.S. Food and Drug Administration has granted priority review to the company’s New Drug Application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, and the FDA has set a target action date under the Prescription Drug User Fee Act of October 10. The FDA has also assigned LDV/SOF a Breakthrough Therapy designation.
07:15 EDTIDIXIdenix announces promising clinical data, continued progress in HCV programs
Idenix Pharmaceuticals announced continued progress of the Company's program to develop nucleotide prodrug inhibitors for the treatment of hepatitis C virus, or HCV, infection. Idenix is reporting potent antiviral activity of mean maximum 4.2-4.3 log10 IU/mL reductions for patients infected with HCV genotype 1, 2 or 3 receiving 300 mg once daily of IDX21437 in the seven-day proof-of-concept portion of a phase I/II clinical trial. Based on this progress, the Company's goal is to initiate a combination clinical trial of IDX21437 and samatasvir, a pan-genotypic NS5A inhibitor, in mid-2014. In addition, Idenix has selected a follow-on uridine-based nucleotide prodrug, IDX21459, from its ongoing nucleotide discovery program and initiated enrollment for the healthy volunteer portion of a phase I clinical trial. In January, Idenix initiated the seven-day proof-of-concept portion of a phase I/II clinical trial for IDX21437. The trial completed enrollment of 44 treatment-naïve, genotype, or GT, 1, 2 or 3 HCV-infected patients. Patients were randomized to receive once-daily doses of placebo, 50 mg, 150 mg, or 300 mg of IDX21437 for seven days. In April 2014, Idenix initiated enrollment for the healthy volunteer portion of a phase I clinical trial of IDX21459 in Europe. This portion of the study is expected to enroll approximately 50 healthy volunteers and will evaluate once-daily doses of IDX21459 ranging from 10 mg – 300 mg. The proof-of-concept portion of the study is expected to enroll a total of 40 treatment-naïve, genotype 1 HCV-infected patients who will receive once-daily doses of placebo, 50 - 300 mg of IDX21459 for seven days. IDX21459 has shown a favorable preclinical profile including potent, pan-genotypic activity and favorable safety with respect to cardiac, mitochondrial and genotoxicity assessments.
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