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News Breaks
June 1, 2014
13:22 EDTABBV, SGEN, RHHBYSeattle Genetics announces data from several collaborator ADC programs
Seattle Genetics (SGEN) announced data from several collaborator antibody-drug conjugate, ADC, programs presented at the American Society of Clinical Oncology, ASCO, 50th Annual Meeting being held May 30 to June 3, 2014 in Chicago, IL. AbbVie (ABBV) presented preliminary data from an ongoing phase 1 clinical trial evaluating the ADC ABT-414 in combination with temozolomide in glioblastoma, and Genentech, a member of the Roche Group (RHHBY), is presenting data from five ADC programs, including two oral presentations. In addition, Progenics presented data from an ADC program under evaluation for castration-resistant prostate cancer. All of the collaborator programs utilize Seattle Genetics’ ADC technology. “Researchers at Seattle Genetics have identified and optimized novel components that are fundamental to creating antibody-drug conjugates, including potent cell-killing agents and conditionally stable linker systems,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “Our collaborators are making great progress in advancing novel ADC candidates as evidenced by the encouraging data presentations at ASCO. Seattle Genetics continues to lead the field in developing ADC candidates, which demonstrate the therapeutic potential of our technology broadly through both our proprietary and collaborator programs.”
News For SGEN;ABBV;RHHBY From The Last 14 Days
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August 27, 2015
07:51 EDTRHHBYRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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August 25, 2015
19:34 EDTABBVExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
09:03 EDTABBVAcorda has major overhang removed by IPR denials, says Leerink
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August 24, 2015
12:01 EDTRHHBYRoche buys nucleic acid purification technology from Lumora
Roche has signed a definitive asset purchase agreement with Lumora for products associated with the patent-protected Heat Elution technology for nucleic acid purification of multiple sample types including challenging formalin-fixed paraffin-embedded tumor samples. Roche plans to explore integrating this technology into its sequencing workflow solution.
August 23, 2015
12:35 EDTRHHBYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
09:38 EDTRHHBYUBS global healthcare analysts hold an analyst/industry conference call
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August 19, 2015
06:09 EDTABBVUnited Therapeutics agrees to sell PPRV to AbbVie for $350M
United Therapeutics (UTHR) announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher, or PPRV, to a subsidiary of AbbVie (ABBV). United Therapeutics received the PPRV when Unituxin was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease. Upon closing of the transaction, United Therapeutics will receive $350M in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
05:57 EDTABBVAbbVie implied volatility of 20 at lower end of index mean range
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.
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).
05:14 EDTRHHBYGenentech reports atezolizumab pivotal Phase II study met primary endpoint
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