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News Breaks
June 17, 2014
05:40 EDTENTA, ABBVAbbVie announces EMA validation of MMAs for GT1 HCV treatment
AbbVie (ABBV) and Entana Pharmaceuticals (ENTA) announced that the Marketing Authorization Applications, or MAAs, for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1, or GT1, hepatitis C virus, or HCV, infection have been validated and are under accelerated assessment by the European Medicines Agency, or EMA. Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie's investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie's regimen could be available for marketing in the European Union in 1Q15. The MAAs were submitted on May 8 and are supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralized licensing procedure, which, when finalized, provides marketing authorizations in all 28 member states of the EU. On June 13, AbbVie announced that the New Drug Application for AbbVie's regimen was accepted and granted priority review by the FDA.
News For ABBV;ENTA From The Last 14 Days
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July 24, 2015
14:56 EDTABBV, ENTAEnanta announces FDA approval of AbbVie's Technivie
Enanta Pharmaceuticals (ENTA) announced that the FDA approved AbbVie’s (ABBV) Technivie -- ombitasvir, paritaprevir and ritonavir -- tablets in combination with ribavirin for the treatment of non-cirrhotic adults with genotype 4 chronic hepatitis C virus, or HCV, infection. Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals (2-DAA) in AbbVie’s Technivie.
14:02 EDTABBVAbbVie says FDA approves hepatitis drug Technivie
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12:54 EDTABBVOn The Fly: Top stock stories at midday
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11:12 EDTABBVFDA approves AbbVie hepatitis drug Technivie
The FDA approved Technivie for use in combination with ribavirin for the treatment of hepatitis C virus, or HCV, genotype 4 infections in patients without scarring and poor liver function. Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection. Technivie is marketed by AbbVie. Reference Link
10:05 EDTABBVAbbVie says has not reached a decision yet on celiac disease
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09:54 EDTABBVAbbVie backs FY15 Humira sales forecast
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09:53 EDTABBVAbbVie CEO says 'probably will' narrow guidance range
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09:37 EDTABBVAbbVie sees Q3 operating revenue growth of about 20%, excluding forex
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09:36 EDTABBVAbbVie sees Q3 adjusted EPS $1.05-$1.07, consensus $1.08
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09:33 EDTABBVAbbVie sees FY15 Lupron sales roughly in line with 2014
AbbVie sees "modest growth" for Synthroid in FY15. Sees AndroGel sales "somewhat above" $500M for 2015.
09:21 EDTABBVAbbVie sees IMBRUVICA U.S. sales of about $1B for 2015
AbbVie Chairman and CEO Richard Gonzalez said the company continues to expect IMBRUVICA to drive U.S. sales of approximately $1B for the full calendar year 2015. Since the company completed the Pharmacyclics transaction, it has seen "additional positive data" and progress on its regulatory objectives, including readouts from two Phase 3 studies, HELIOS and RESONATE-2, noted Gonzalez during the company's Q2 earnings conference call.
07:56 EDTABBVAbbVie reports Q2 Viekira sales $385M, Q2 Imbruvica sales $234M
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07:55 EDTABBVAbbVie reports Q2 Global Humira sales up 16.4% to $3.54B
Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.
07:54 EDTABBVAbbVie backs FY15 adjusted EPS $4.10-$4.30, consensus $4.24
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07:54 EDTABBVAbbVie reports Q2 adjusted EPS $1.08, consensus $1.06
Reports Q2 revenue $5.48B, consensus $5.62B
July 23, 2015
15:05 EDTABBVNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include AbbVie (ABBV), consensus $1.06... Biogen (BIIB), consensus $4.10... Simon Property Group (SPG), consensus $2.36... State Street (STT), consensus $1.37... V.F. Corp. (VFC), consensus 36c... Johnson Controls (JCI), consensus 91c... American Airlines (AAL), consensus $2.60... Rockwell Collins (COL), consensus $1.30... Cabot Oil & Gas (COG), consensus 4c... Lear (LEA), consensus $2.48... Encana (ECA), consensus (15c).
14:55 EDTABBVAbbVie technical comments before earnings news
The stock is trading close to its life high at $71.60 ahead of earnings news. On a 2-year chart basis recent high price and the near-matching high from December of last year indicates shares are at major resistance. If the news is a bearish surprise, these two peaks in price could be construed as potential double top. Next supports below $70 would be at $68.50, $66.52, and $64.81. If the news is a bullish surprise, the life high could easily be taken out. An extension of the current bullish price channel in time yields a potential target at $75. Without overhead resistance, that level could be exceeded depending on the nature of the news.
13:56 EDTABBVEarnings Watch: AbbVie sees Q2 EPS $1.04-$1.06
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July 22, 2015
10:01 EDTABBVOn The Fly: Analyst Initiation Summary
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07:04 EDTABBVAbbVie initiated with a Buy at SunTrust
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