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January 27, 2014
Cell & Gene Therapy Forum 2014 is being held in Washington, D.C. on January 27-29.
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September 27, 2015
16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
16:17 EDTCELGOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., the third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
16:00 EDTPFEOptions Update; September 25, 2015
iPath S&P 500 VIX Short-Term Futures up 66c to 25.09. Option volume leaders: AAPL NFLX BAC FB AU NKE PFE INTC AMZN TSLA
12:38 EDTBIIBOptions with increasing implied volatility
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11:35 EDTBLUEbluebird bio management to meet with Maxim
5:30 pm Cocktails, followed by 6pm Group dinner with management will be held in New York on September 30 hosted by Maxim.
09:34 EDTPFEActive equity options trading on open
Active equity options trading on open: AAPL BAC FB NKE NFLX PFE AU TSLA
08:04 EDTFCSC, XONFibrocell, Intrexon provide update for RDEB treatment
Fibrocell (FCSC) and Intrexon (XON) provided an update on the status of the previously filed Investigational New Drug application for FCX-007, Fibrocell's orphan gene-therapy drug candidate for the treatment of recessive dystrophic epidermolysis bullosa, including feedback from the U.S. Food and Drug Administration on the IND. The FDA's feedback related to the proposed Phase I/II clinical trial protocol and the areas of CMC and toxicology. With respect to toxicology, a hybrid pharmacology/toxicology study based on the injection of FCX-007 in RDEB human skin that was xenografted onto SCID mice was included in the IND and showed no signs of toxicity. However, the FDA has now requested that Fibrocell execute a toxicology-specific study in which FCX-007 will be injected in non-grafted SCID mice. The new toxicology study is targeted to initiate in the fourth quarter of 2015. Fibrocell expects to amend the IND in response to the FDA's feedback and to include data from the new toxicology study in the first quarter of 2016.
07:55 EDTBIIBBiogen, Sobi receive position opinion for Elocta from CHMP
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07:32 EDTBIIBBiogen, Sobi receive positive CHMP opinion for Elocta for Hemophilia A
Biogen and Swedish Orphan Biovitrum AB received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of ELOCTA. ELOCTA is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the European Union. The positive opinion was based on results from the pivotal, Phase 3 A-LONG clinical study, which examined the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe hemophilia A, and from the Phase 3 Kids A-LONG clinical study, which evaluated the efficacy and safety of rFVIIIFc in previously treated male children with hemophilia A under 12 years of age. The Committee's positive opinion is now referred to the EC, which grants marketing authorization for medicines in the EU. ELOCTA is the European trade name for rFVIIIFc, which is also known as ELOCTATE in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A. Commonly reported adverse drug reactions in the clinical studies were arthralgia, malaise, myalgia, headache and rash. Development of Factor VIII neutralizing antibodies may occur following administration of ELOCTA. Biogen and Sobi are collaboration partners in the development and commercialization of ELOCTA/ELOCTATE for hemophilia A. Last year, Sobi exercised its opt-in right to assume final development and commercialization of ELOCTA in the Sobi territories. Biogen leads development for ELOCTA/ELOCTATE, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
07:22 EDTNVS, SNY, PFE, CELGEuropean Society for Medical Oncology to hold a conference
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07:03 EDTPFEMerck KGaA, Pfizer announce FDA orphan drug designation for avelumab
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05:21 EDTCELGCelgene's VIDAZA receives positive CHMP opinion
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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05:08 EDTPFEStocks with implied volatility movement; PFE HLF
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September 24, 2015
18:38 EDTNVSNovartis CEO discusses drug pricing, paying doctors, Washington Post reports
Novartis CEO Joseph Jimenez said in an interview with the Washington Post, "Drug pricing is a very complicated topic because we invest in high-risk activity... So when we price a drug, we price it based on the value it will bring into that marketplace, and also how its price compares to the other therapies currently on the market. There's been a lot of discussion about drug pricing. What we have to do is we have to shift that conversation away from the price toward the value. Like, what exactly is the value of this drug that is going to result in a positive outcome? And is society willing to pay for that drug? At Novartis, we take a little bit of a different approach than our peers. Not only are we a large, innovative drug manufacturer, but we also are the second largest generics manufacturer... I also believe at Novartis that the day that patents expire, it's our obligation to offer a low-cost version in a generic form." Discussing the practice of drug companies paying doctors to prescribe particular drugs, Jiminez said, "It's unfortunate, because that's a situation where society's expectations have changed to the point where even doing what's legal is not doing what's right. What we have to do is, we have to find new ways to educate physicians about our new drugs... We're looking at ways digitally to communicate with physicians and at some new tools, so we can stay ahead of the curve. So rather than wait for regulations to change, Novartis can step back and say, 'We're going to do what society would expect us to do, not just do what's legal.'" Reference Link
17:04 EDTPFEMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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09:07 EDTNVSUnilife ammends clinical supply agreement with Novartis
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07:33 EDTPFEBIND says Pfizer exercises option to obtain license for Accurin drug candidate
BIND Therapeutics (BIND) announced that Pfizer (PFE) exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies' global collaboration agreement. The actively targeted Accurin is designed to impart cellular targeting capability and was engineered by BIND using one of Pfizer's proprietary kinase inhibitors and one of BIND's proprietary ligands. As a result of the option exercise, BIND will receive a $2.5 million option exercise fee from Pfizer. In parallel with exercising its first option, Pfizer informed BIND that it will not exercise its option for the second compound in the collaboration. Under terms of the original collaboration agreement, which was established in April 2013, Pfizer was granted options to obtain exclusive licenses to pursue development and commercialization of two Accurins that incorporate specified Pfizer small molecular targeted therapies. For the Accurin that has been selected, both companies will work together on preclinical research; Pfizer will have responsibility for development and commercialization, and BIND will conduct chemistry, manufacturing and control activities. In addition to the $2.5 million option exercise fee, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million preclinical development milestone for the selected Accurin in December 2014. BIND has the potential to receive additional milestone payments for the selected Accurin of up to $86.0 million in aggregate upon the achievement of additional specified development and regulatory events under the Pfizer collaboration agreement. BIND may also receive additional milestone payments for the selected Accurin of up to $110 million in aggregate for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of the selected Accurin, if any.
05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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