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Stock Market & Financial Investment News

News Breaks
March 5, 2014
10:33 EDTOSUR, ABBV, MRK, GILDOraSure climbs after CMS proposes coverage of HCV tests
Shares of OraSure (OSUR), whose hepatitis C virus test has been approved by the FDA, are climbing after the Centers for Medicare & Medicaid Services yesterday proposed a rule that would enable Medicare and Medicaid to cover HCV tests in some circumstances. Orasure's OraQuick HCV test detects HCV antibodies in fingerstick and venipuncture whole blood. WHAT'S NEW: CMS proposed a rule under which the government would cover HCV tests that have been approved by the FDA. In order to be covered, the test must be ordered by beneficiaries' doctors, and performed by an eligible Medicare provider, CMS stated. Additionally, under the proposal the government would only cover tests for adult beneficiaries who are at high risk for HCV infection, and for those people born between 1945 and 1965. Individuals who have used illegal drugs or received blood transfusions before 1992 would be considered at risk individuals for the purposes of the rule, the agency stated. ANALYST REACTION: In a note to investors earlier today, Mizuho Securities analyst Peter Lawson wrote that the CMS' decision is positive for OraSure. The company has the largest exposure to HCV testing among publicly traded companies, the analyst indicated. The company could obtain over $1B of revenue by providing HCV tests for beneficiaries born between 1945 and 1965, the analyst estimated. Moreover, HCV drug developers will also use OraSure's test in the wake of CMS' decision, added Lawson, who reiterated a $9 price target and Outperform rating on the stock. PRICE ACTION: In early trading, OraSure climbed 11cv, or 1.5%, to $7.50. OTHERS TO WATCH: Companies developing HCV treatments include AbbVie (ABBV), Merck (MRK) and Gilead (GILD).
News For OSUR;ABBV;MRK;GILD From The Last 14 Days
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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.
September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merckís investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
11:56 EDTGILDStocks with call strike movement; MU GILD
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10:55 EDTABBVRegulators to determine AbbVie, Shire deal by next month, Reuters says
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10:52 EDTGILDGilead heading for a test of support, levels to watch
The shares are down 2% to $101.54 at time of writing, putting the shares on track for a retest of the 30-day moving average at $101.21. A breakdown below that level would indicate a pickup in negative price momentum, with next support at $96.57, the 50-day moving average. A bounce from the 30-day would meet resistance at $106.93, the 10-day moving average.
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TSLA RSH YHOO GILD TWTR AVNR NFLX BAC C
06:34 EDTGILDMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
06:31 EDTGILDGilead announces licensing agreements with seven pharmaceutical companies
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September 12, 2014
14:56 EDTGILDGilead mentioned cautiously at ISI Group
07:32 EDTABBVBiogen, AbbVie announce ZINBRYTA DECIDE Phase 3 study results
Biogen (BIIB) and AbbVie (ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis. Patients on ZINBRYTA demonstrated a statistically significant 45% reduction in annualized relapse rate compared to patients treated with AVONEX. Based on the efficacy and safety data from the ZINBRYTA clinical development program, Biogen Idec and AbbVie plan to file marketing applications for ZINBRYTA with regulatory authorities during 1H15.
September 11, 2014
11:58 EDTGILDStocks with call strike movement; DDD GILD
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05:34 EDTABBVAbbVie reports Humira Phase 3 trial meets primary endpoint
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September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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10:24 EDTABBVEnanta announces AbbVie initiated Phase 2b trial with ABT-493
Enanta (ENTA) announced that AbbVie (ABBV) initiated a phase 2b clinical study with ABT-493, Enantaís next-generation protease inhibitor. ABT-493 is the second clinical-stage protease inhibitor candidate developed within the Enanta-AbbVie collaboration. The phase 2b study being conducted by AbbVie will evaluate the safety and efficacy of ABT-493 co-administered with ABT-530 in HCV patients. AbbVie has informed Enanta that results from this trial are expected in 2015 and AbbVie plans to start phase 3 development of the combination next year.
September 9, 2014
09:34 EDTGILDGilead recently started cutting Sovaldi pricing by 8%, says Cleveland Research
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