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News Breaks
April 8, 2014
04:55 EDTBCR, BCR, ISIS, ISIS, TRVN, TRVN, SGEN, SGEN, ONCS, ONCS, KBIO, KBIO, GNMK, GNMK, LXRX, LXRX, ACAD, ACAD, EXAM, EXAMNeedham to hold a conference
Life Sciences Conference is being held in New York on April 8-9.
News For BCR;ACAD;LXRX;GNMK;KBIO;ONCS;SGEN;TRVN;ISIS;EXAM From The Last 14 Days
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August 27, 2015
10:00 EDTBCROn The Fly: Analyst Initiation Summary
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10:00 EDTBCR, ACADOn The Fly: Analyst Upgrade Summary
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07:09 EDTBCRC.R. Bard initiated with a Sector Weight at KeyBanc
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06:37 EDTACADACADIA upgraded to Overweight from Neutral at Piper Jaffray
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06:14 EDTBCRC.R. Bard upgraded to Buy from Neutral at Goldman
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August 25, 2015
09:59 EDTACADOn The Fly: Analyst Initiation Summary
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09:07 EDTACADACADIA initiated with a Buy at Aegis
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August 24, 2015
08:29 EDTGNMKWilliam Blair to hold a field trip
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06:03 EDTONCSOncoSec promotes Sheela Mohan-Peterson to Chief Legal and Compliance Officer
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August 21, 2015
16:38 EDTACADACADIA unit manufacturing agreement with BASF Pharma
On August 17, our Swiss subsidiary, ACADIA Pharmaceuticals GmbH, entered into a co-operation agreement and product schedule, collectively referred to as the manufacturing agreement, with BASF Pharma SA, or BASF. Under the manufacturing agreement, BASF has agreed to manufacture and supply pimavanserin tartrate, the active pharmaceutical ingredient of NUPLAZID, for commercial use. The term of the manufacturing agreement extends through December 31, 2020 and will automatically renew for subsequent one year terms unless either party provides timely notice of its intent not to renew, or unless the manufacturing agreement is terminated earlier pursuant to its terms.
August 18, 2015
06:23 EDTSGENSeattle Genetics approvals already factored into forecast, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff believes the FDA approval for Adcetris in post-transplant consolidation Hodgkin's Lymphoma as well as the "positive surprise" of the FDA converting the accelerated approval in relapsed HL to standard approval is already factored into in his sales forecast of $220M this year for the drug. He keeps an Underweight rating on Seattle Genetics with a $30 price target.
06:06 EDTONCSOncoSec announces first patient enrolled in ImmunoPulse Phase II clinical trial
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August 17, 2015
19:00 EDTSGENOn The Fly: After Hours Movers
UP AFTER EARNINGS: Fabrinet (FN), up 5.1%. ALSO HIGHER: Esperion Therapeutics (ESPR), up 10.6% after announcing that it is on track to initiate ETC-1002 Phase 3 program by the end of 2015... Seattle Genetics (SGEN), up 3.3% after announcing FDA approval of Adcetris for HL treatment. DOWN AFTER EARNINGS: MasTec (MTZ), down 7.4%... Urban Outfitters (URBN), down 2.3%. ALSO LOWER: Sunedison (SUNE), down 1% after announcing a $500M perpetual convertible preferred stock offering.
16:14 EDTSGENSeattle Genetics announces FDA approval of Adcetris for HL treatment
Seattle Genetics announced that the U.S. Food and Drug Administration has approved ADCETRIS, brentuximab vedotin, for the treatment of patients with classical Hodgkin lymphoma, HL, at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation. The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles of ADCETRIS therapy administered every three weeks following auto-HSCT to placebo. The primary endpoint was met with a significant improvement in median progression-free survival of 42.9 months for patients who received ADCETRIS versus 24.1 months for patients who received placebo, an improvement of 18.8 months. In addition, data from the AETHERA trial converted the U.S. accelerated approval of the relapsed classical HL indication to regular approval. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, as well as other lymphoma subtypes. This is the third indication for ADCETRIS, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of Hodgkin lymphoma patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates, and (2) treatment of systemic ALCL patients who fail at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
06:22 EDTSGENPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).

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