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Stock Market & Financial Investment News

News Breaks
May 16, 2014
10:25 EDTSNY, SNY, SNY, SGEN, SGEN, SGEN, RHHBY, RHHBY, RHHBY, PCYC, PCYC, PCYC, NVS, NVS, NVS, MRK, MRK, MRK, JNJ, JNJ, JNJ, INFI, INFI, INFI, IMGN, IMGN, IMGN, GILD, GILD, GILD, CELG, CELG, CELG, BMY, BMY, BMY, BLUE, BLUE, BLUE, AMGN, AMGN, AMGN, ABBV, ABBV, ABBVLeerink pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts provide an update on GU cancer, in conjunction with the upcoming ASCO Annual Meeting, where relevant companies ABBV, AMGN, BLUE, BMY, CELG, GILD, IMGN, INFI, JNJ, MRK, NVS, PCYC, RHHBY, SGEN and SNY may be discussed on the Analyst/Industry conference call to be held on May 23 at 11 am.
News For ABBV;AMGN;BLUE;BMY;CELG;GILD;IMGN;INFI;JNJ;MRK;NVS;PCYC;RHHBY;SGEN;SNY From The Last 14 Days
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August 20, 2015
06:01 EDTBMYBristol-Myers announces Canadian approval of Daklinza
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05:29 EDTNVSNovartis Odomzo gains EU approval for laBCC
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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
05:46 EDTBMYStocks with implied volatility movement; ESRX BMY
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August 18, 2015
12:13 EDTMRKMerck recalls Temodar, Temozolomide bottles with cracked caps
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12:06 EDTAMGNAmgen to pay $71M in 48-state settlement over Aranesp, Enbrel promotions
West Virginia Attorney General Patrick Morrisey announced his Office has participated in a $71M multi-state settlement with Amgen to resolve allegations it unlawfully promoted the biologic medications Aranesp and Enbrel. West Virginia will receive $845,637.82 as part of the settlement, which was negotiated between the company and Attorneys General from 48 states and the District of Columbia. A complaint in the matter was filed Tuesday morning in Kanawha County Circuit Court. Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel is used to treat a number of conditions, including plaque psoriasis. In addition to the $71M settlement, the agreement requires Amgen to reform its marketing and promotional practices. In addition to West Virginia, the other states participating in this settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming and the District of Columbia.
09:19 EDTNVS, AMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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09:07 EDTAMGNAmgen and University of California announce education program partnership
Amgen and the Center for Social Sector Leadership at the University of California, or UC, Berkeley's Haas School of Business announced a multi-year partnership to offer a graduate-level course on measuring outcomes of cancer patient advocacy education and support programs. The MBA course, Social Impact Metrics, is designed to advance the ability of nonprofit organizations to measure the effectiveness of their programs, which is critical in an increasingly challenging donor environment. The overall goal of the initiative is to create a set of measurement best practices that can be adopted across the cancer nonprofit community and beyond.
08:03 EDTMRKMerck says FDA accepts sBLA for Keytruda
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07:22 EDTBMYBristol-Myers combo data could push shares above $70, says JPMorgan
JPMorgan analyst Chris Schott says the risk/reward for shares of Bristol-Myers Squibb looks "very attractive" ahead of the World Conference on Lung Cancer, which begins September 6. Data at the conference supportive of an Opdivo/Yervoy combo would represent a clear catalyst for the shares, Schott tells investors in a research note. Bristol is "already extremely well-positioned" in the advanced non-small cell lung cancer market, and data suggesting that the company has addressed toxicity concerns with the combo could push the stock above $70, Schott argues. Bristol closed yesterday up 39c to $63.47. The analyst sees limited downside to stock even with disappointing results at the World Conference on Lung Cancer. He reiterates an Overweight rating on Bristol with a $75 price target.
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.
13:30 EDTNVSOn The Fly: Top stock stories at midday
Stocks began the session deep in negative territory after a disappointing Empire Manufacturing report. The data got the market off to a weak start as optimism over last week's finish began to fade. The averages continued to drift in a narrow range for the opening hour before reversing and capturing the opening losses. Each of the major equity indices is now back in positive territory sporting slight gains across the board. ECONOMIC EVENTS: In the U.S., the Empire State manufacturing index plunged to -14.92 in August after rebounding to 3.86 in July from June's -1.98. The consensus estimate was 4.75, and the surprising drop puts the index at its lowest point since April 2009. The employment component slid to 1.82, while new orders crashed to -15.70. Meanwhile, the U.S. NAHB homebuilder sentiment index rose to 61 in August from 60 in June and and is the highest since November 2005. The single family sales index edged up to 66 versus a revised 65 last month, while the index of prospective buyer traffic improved to 45 versus 43 previously. In Europe, various Eurozone parliaments prepare to vote on Greece's new EUR86B bailout plan this week. COMPANY NEWS: Liberty Interactive (QVCA) announced this morning an agreement to acquire zulily (ZU) for $18.75 per share in a deal valuing the online shopping site at $2.4B, driving zulily shares up more than 47% in intraday trading. The acquisition will be attributed to Liberty's QVC Group tracking stock, though QVC and zulily will be operated as separate consumer facing brands. On a conference call discussing the acquisition, Liberty Interactive executives noted that the "highly efficient" deal will allow Liberty to reach a younger base. MAJOR MOVERS: Among the notable gainers AVEO Oncology (AVEO), which rose roughly 50% after announcing a license agreement with Novartis (NVS) for the development and commercialization of AVEO's AV-380 drug and related antibodies. Also higher was Kite Pharma (KITE), which advanced roughly 5.4% after clarifying that an earlier patient death in its Phase 1/2 KTE-C19 trial for non-Hodgkin's lymphoma was unrelated to Kite's therapy. Additionally, shares of Target (TGT) have gained roughly 10c despite lingering in negative territory early Monday after the company promoted CFO John Mulligan to the newly created role of EVP and COO and appointed Cathy Smith as EVP and CFO. Prior to joining Target, Smith served as EVP and CFO at St. Louis-based Express Scripts (ESRX). Among the noteworthy losers was KKR (KKR), which lost roughly 2.4% after Samson Resources announced a restructuring agreement late Friday, adding that it expects to file for bankruptcy within 30 days. Also lower was Estee Lauder (EL), which declined nearly 6.5% after its quarterly guidance missed analysts' estimates. INDEXES: Near midday, The Dow was up 65.11, or 0.37%, to 17,542.51, the Nasdaq gained 34.73, or 0.69%, to 5,082.96, and the S&P 500 advanced 8.80, or 0.42%, to 2,101.03.
08:43 EDTBMYBristol-Myers sells Ixempra to R-PHARM, terms not disclosed
R-PHARM announces the acquisition of Ixempra from Bristol-Myers Squibb. Ixempra received marketing approval from the FDA in 2007 and in 18 other markets globally. Ixempra is indicated as monotherapy or in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. With the acquisition, R-PHARM has launched its U.S. commercial operations, and it is now responsible for all activities surrounding Ixempra's manufacture, distribution, sales, and reimbursement. Financial terms were not disclosed.
08:23 EDTAMGNDeutsche Bank biotech analyst holds an analyst/industry conference call
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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).
06:01 EDTNVSAVEO Oncology announces license agreement with Novartis
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05:14 EDTRHHBYGenentech reports atezolizumab pivotal Phase II study met primary endpoint
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