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News Breaks
April 20, 2014
16:45 EDTBIIB, PFEBiogen hemophilia drug Alprolix priced similar to older treatments, Reuters says
Biogen (BIIB) is pricing its recently approved hemophilia drug Alprolix on par with older therapies for U.S patients, says Reuters. The decisions by Biogen may put pressure on competitors like Pfizer (PFE) to lower prices for existing hemophilia treatments, added Reuters. Reference Link
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July 24, 2014
06:24 EDTBIIBBiogen price target raised to $387 from $343 at Citigroup
Citigroup raised its price target for Biogen shares to $387 citing the company's earnings and revenue growth following its better than expected Q2 results. Citi keeps a Buy rating on the stock.
July 23, 2014
11:43 EDTBIIBBiogen announces PLEGRIDY EC approval
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10:25 EDTBIIBBiogen price target raised to $420 from $370 at Piper Jaffray
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09:50 EDTBIIBBiogen says strategic bias still tuck-in acquisitions
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09:37 EDTBIIBBiogen says 'clearly' has considered tax inversion
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09:25 EDTBIIBBiogen sees Japan as an attractive growth opportunity for company
Says remains committed to SG&A leverage in 2014. Says guidance assumes Tecfidera EU uptake similar to U.S.
09:17 EDTBIIBOn The Fly: Pre-market Movers
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09:05 EDTBIIBBiogen says received letter from EU saying PLEGRIDY has been approved
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08:56 EDTBIIBBiogen still sees FY CapEx approximately $300M
Believes TECFIDERA is on track to become the leading MS product in the U.S. Says outside the U.S., demand for TECFIDERA has been broad; launch trajectories similar to experience in U.S. Continues to be in discussions with AIFA to resolve its dispute on Tysabri for February 2009-January 2013. Says FY guidance "meaningfully increased" due primarily to the  growth  of  TECFIDERA in the U.S. and the EU., the strength of our other MS therapies and clarity on the AIFA pricing matter. Comments from slides that will be presented on the Q2 earnings conference call.
06:50 EDTBIIBBiogen raises FY14 EPS to $12.90-$13.10 from $11.35-$11.45, consensus $11.53
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06:48 EDTBIIBBiogen reports Q2 Tecfidera revenue $700M; Reports Q2 Avonex revenue $774M
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06:47 EDTBIIBBiogen reports Q2 adjusted EPS $3.49, consensus $2.83
Reports Q2 revenue $2.42B, consensus $2.16B; Non-GAAP diluted EPS was benefited by approximately 15c, following the approval from an agreement with the Italian National Medicines Agency relating to Tysabri sales in Italy.
July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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14:30 EDTBIIBBiogen technical remarks ahead of earnings
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July 21, 2014
07:37 EDTBIIBBiogen July weekly volatility elevated into Q2 and outlook
Biogen July weekly call option implied volatility is at 55, August is at 34, October is at 36; compared to its 26-week average of 33 according to Track Data, suggesting large near term price movement into the expected release of Q2 on July 23.
July 17, 2014
08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
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