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Stock Market & Financial Investment News

News Breaks
June 10, 2014
12:13 EDTMRK, GILD, IDIX, ACHN, ABBVAchillion surges after FDA lifts hold, buyout speculation continues
Shares of hepatitis C treatment maker Achillion (ACHN) are rising dramatically for a second day after Merck (MRK) yesterday announced that it would acquire another company in the space. Meanwhile, Achillion announced today that it had received favorable news from the FDA about resuming certain clinical trials and added that it had begun a Phase I trial of one of its hepatitis C, or HCV, treatments, ACH-3422. WHAT'S NEW: Achillion is rallying for a second straight day after Merck announced that it had acquired Idenix (IDIX). Like Achillion, Idenix is a smaller company that has developed HCV treatments and, also like Idenix, one of Achillion's HCV treatments is a nucleotide. Achillion earlier today announced that the FDA had removed its clinical hold on sovaprevir. As a result of the FDA's decision, Achillion will be able to conduct clinical trials of the drug, the company stated. The FDA placed a hold on the drug last year after a number of patients developed elevated liver enzymes while taking it. Also today, Achillion announced that it had begun dosing patients with ACH-3422 in a Phase I clinical trial. ANALYST REACTION: In a note to investors earlier today Edward Tenthoff, an analyst at research firm PiperJaffray, wrote that today's news positions Achillion as a takeover target. Additionally, the company could develop a nucleotide HCV treatment that is competitive with Gilead's successful Sovaldi, Tenthoff wrote. However, Tenthoff believes that potential buyers of Achillion may wait for more data on its products to be unveiled later this year before looking to bid. The analyst kept a Neutral rating on the stock. WHAT'S NOTABLE: Gilead and AbbVie (ABBV), whose stocks fell yesterday after Merck announced its acquisition, were defended today by RBC Capital and BMO Capital, respectively. RBC Capital expects sales of Gilead's Sovaldi to come in well above consensus estimates for 2015, potentially enabling the company's EPS to reach $8-$10. The market expects the sales of all HCV treatments to drop significantly in 2016, but the firm does not agree with this outlook and kept an Outperform rating on Gilead. Meanwhile, BMO Capital defended AbbVie. BMO still believes that the size and durability of the HCV market and AbbVie's franchise are underappreciated. The firm sees Merck as a significant competitor in HCV, but added that the potential of the assets it acquired from Idenix is "uncertain and somewhat risky." BMO kept an Outperform rating on AbbVie and continued to identify it as a top pick. PRICE ACTION: In early afternoon trading, Achillion surged 54% to $6.54. The stock had advanced more than 47% yesterday. Also near noon, Gilead rose 0.7% to $79.54, while Abbvie fell 0.9% to $53.38.
News For ACHN;GILD;ABBV;IDIX;MRK From The Last 14 Days
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July 24, 2015
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
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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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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12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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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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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
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