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News Breaks
July 21, 2014
07:21 EDTGILD, MRKGilead could be hurt by new HCV drugs, says Wells Fargo
Noting that data on a new Merck (MRK) HCV treatment is expected in November, Wells Fargo thinks Merck's HCV drug could be combined with Gilead's (GILD) Sovaldi to shorten the duration of treatment to four weeks. Other companies could take similar actions, and Gilead's per patient revenues would be significantly reduced if this occurs, the firm warned. However, it continues to have an upbeat outlook on Gilead heading into what it sees as a strong quarter and is still upbeat on the company's long-term HCV opportunity. It keeps an Outperform rating on Gilead.
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September 24, 2014
09:28 EDTGILDGilead price target raised to $118 from $111 at Piper Jaffray
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08:39 EDTGILDGilead's two TAF Phase 3 trials meet primary objectives
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05:12 EDTGILDGilead submits NDA to Japan for fixed-dose combination of Ledipasvir/Sofosbuvir
Gilead Sciences announced that the company has submitted a New Drug Application, or NDA, to Japanís Pharmaceutical and Medical Devices Agency, or PMDA, for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir, or LDV, 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, 400 mg for the treatment of chronic genotype 1 hepatitis C virus, or HCV, infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naÔve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin, or RBV. LDV/SOF is currently under regulatory review in the United States and European Union.
September 23, 2014
08:07 EDTGILDFDA Pediatric Advisory Committee to hold a meeting
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07:33 EDTMRKOphthotech names Michael Atieh as EVP, Chief Financial and Business Officer
Ophthotech Corporation (OPHT) announced that Michael G. Atieh has been named EVP, Chief Financial and Business Officer and Treasurer effective September 30. Atieh replaces Bruce A. Peacock, Chief Financial and Business Officer and Treasurer, who has notified the company of his intention to retire effective September 30. Atieh spent the majority of his career in the pharmaceutical industry with Merck and Co (MRK), where he held various senior level positions over a 20 year period including Senior Vice President-Merck Medco Managed Care, Vice President-U.S. Human Health, Vice President-Public Affairs, Vice President-Government Relations, and Treasurer.
September 22, 2014
09:15 EDTGILDIntercept recent weakness a buying opportunity, says Summer Street
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06:51 EDTMRKMerck to host conference call
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September 19, 2014
11:26 EDTGILDStocks with call strike movement; TSLA GILD
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09:37 EDTGILDActive equity options trading on open
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06:25 EDTGILDGilead granted marketing aurhotization from European Commission for Zydelig
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06:11 EDTGILDGilead price target raised to $139 from $111 at Citigroup
Citigroup raised its price target for Gilead shares to $139 saying management looks "very optimistic" that FY15 hepatitis C treatment volumes could be up substantially over FY14 rates globally. Citi also expects recent buybacks to boost Q4 earnings substantially and that future stock buybacks will drive appreciation. The firm keeps a Buy rating on Gilead.
September 18, 2014
12:12 EDTGILDStocks with call strike movement; PIR GILD
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08:48 EDTMRKNeogen's dairy genomic program to be marketed by Merck
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08:17 EDTGILDGilead trial failure not material, says FBR Capital
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September 17, 2014
11:52 EDTGILDStocks with call strike movement; X GILD
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09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merckís investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
06:04 EDTGILDGilead's simtuzumab Phase 2 study for pancreatic cancer does not meet endpoint
Gilead announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2, in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, the addition of simtuzumab to gemcitabine did not significantly increase progression-free survival compared to placebo plus gemcitabine. There was no difference in adverse events between patients taking simtuzumab versus placebo. Simtuzumab is being evaluated in several ongoing Phase 2 trials, including for advanced colorectal cancer, myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis, and for liver fibrosis. Other agents in Gileadís oncology pipeline are currently being evaluated in clinical trials for the treatment of pancreatic cancer.
September 16, 2014
07:31 EDTMRKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
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