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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 23, 2014
08:07 EDTGILDFDA Pediatric Advisory Committee to hold a meeting
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08:03 EDTABBVAbbVie to present several oncology pipeline studies
AbbVie announced that data from several clinical studies evaluating potential new medicines in the company's oncology pipeline will be presented at the upcoming 2014 European Society of Medical Oncology Annual Congress, September 26-30, in Madrid, Spain. Data being presented include results from a Phase 2 study evaluating the safety and efficacy of veliparib, or ABT-888, a poly polymerase inhibitor, in combination with two broad-acting chemotherapeutic medicines in patients with non-small cell lung cancer. Results from a Phase 1 study of ABT-414 in patients with newly diagnosed glioblastoma multiforme will also be presented during an oral presentation. Reference Link
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
10:21 EDTOSUROraSure management to meet with JMP Securities
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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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11:15 EDTABBVRepros sinks after panel backs tests for testosterone therapies
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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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06:10 EDTABBVFDA panel votes 20-1 to study changes to testosterone therapies
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September 17, 2014
12:50 EDTOSUROraSure management to meet with Jefferies
Meetings to be held on Los Angeles/San Francisco on September 22-23 hosted by Jefferies.
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.
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