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News Breaks
March 5, 2014
10:33 EDTABBV, GILD, OSUR, MRKOraSure 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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April 14, 2015
13:32 EDTMRKMerck, NewLink Genetics confirm initiation of Phase 3 trial of Ebola vaccine
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April 13, 2015
16:01 EDTGILDOptions Update; April 13, 2015
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14:07 EDTABBVEarnings Watch: Johnson & Johnson shares down slightly since last earnings
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10:00 EDTABBVOn The Fly: Analyst Upgrade Summary
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09:34 EDTGILDActive equity options trading on open
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08:58 EDTMRKMerck may have positive read through from briefing docs, says SunTrust
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08:34 EDTABBVAbbVie upgraded on Imbruvica outlook at BMO Capital
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07:02 EDTABBVAbbVie upgraded to Outperform from Market Perform at BMO Capital
April 10, 2015
16:05 EDTGILDOptions Update; April 10, 2015
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April 9, 2015
09:25 EDTMRKPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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06:12 EDTGILDSovaldi prices causes Medicaid spending for hepatitis C drugs to soar, WSJ says
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April 8, 2015
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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05:30 EDTABBVEnanta announces data on regimens containing protease inhibitors paritaprevir
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April 7, 2015
17:58 EDTGILDGilead submits NDA for investigational combination for treatment of HIV-1
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16:00 EDTGILDOptions Update; April 7, 2015
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07:31 EDTABBVBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTMRKEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
07:36 EDTGILDGilead Q1 HCV revenue poised to beat expectations, says RBC Capital
After analyzing weekly prescription data, RBC Capital believes that Gilead's weekly hepatitis C prescriptions are tracking towards $3.5B-$3.6B of revenue from hepatitis C drugs for Q1, versus the consensus outlook of about $2.6B. The firm keeps an Outperform rating on Gilead.
April 5, 2015
14:43 EDTGILDActavis seeks FDA approval to market generic version of Gilead's Letairis
Actavis (ACT) on Friday, confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. Actavis' ANDA product is a generic version of Gilead Science's (GILD) Letairis, which is a treatment for pulmonary arterial hypertension. Gilead Sciences and Royalty Pharma Collection Trust filed suit against Actavis on April 1, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent number RE42,462. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Letairis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, Letairis had global sales of approximately $595M, according to Gilead.
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