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March 19, 2013
13:15 EDTLPTN, LPTN, REGN, REGN, AGN, AGN, NVS, NVS, RHHBY, RHHBYSummer Street's biotech research team holds analyst/industry conference call
Biotech Analyst Research Team discusses current and future treatments for wet age-related macular degeneration on an Analyst/Industry conference call. Companies which may be discussed include LPTN, REGN, AGN, NVS and RHHBY on an Analyst/Industry conference call to be held on March 19 at 1:30 pm.
News For LPTN;REGN;AGN;NVS;RHHBY From The Last 14 Days
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September 28, 2015
07:52 EDTAGN, REGN, RHHBYIIR Holdings to hold a conference
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05:18 EDTREGNRegeneron and Sanofi announce of approval of Praluent in EU
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission has granted marketing authorization for Praluent for the treatment of bad cholesterol, known as low-density lipoprotein cholesterol, in certain adult patients with hypercholesterolemia. Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses as a single 1-milliter injection once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer. The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
05:15 EDTRHHBYGenentech announces Phase III study of ocrelizumab met primary endpoint
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September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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17:02 EDTRHHBYNewLink Genetics reports early Phase 1a data on GDC-0919
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16:42 EDTRHHBYRoche present Phase 2 results on atezolizumab for urothelial cancer
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16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.
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 EDTREGNOn 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.
09:07 EDTREGNBayer says Eylea recommended for EU approval in additional indication
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08:00 EDTAGNAllergan launches generic version of INVEGA
Allergan announced that it has launched a generic version of Janssen's INVEGA in the U.S. Allergan is the first company to receive FDA approval for and launch a generic version of INVEGA, demonstrating the deep expertise of the Company's global generics R&D, regulatory and supply chain teams.
07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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07:22 EDTNVS, RHHBYEuropean Society for Medical Oncology to hold a conference
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06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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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
14:17 EDTAGNAppeals court affirms Shire Vyvanse patents valid until 2023
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09:07 EDTNVSUnilife ammends clinical supply agreement with Novartis
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08:33 EDTREGNRegeneron and Icahn School of Medicine enter antibody research agreement
Regeneron and The Experimental Therapeutics Institute at the Icahn School of Medicine at Mount Sinai today announced that they have entered into an agreement with the goal of accelerating the discovery of fully human antibodies directed against therapeutic targets being researched by Mount Sinai investigators. Regeneron will provide the ETI with access to VelocImmune technology and potential financial support to use the company's proprietary antibody discovery platform to generate antibodies against targets of interest and explore potential therapeutic applications for human disease. ETI will undertake preclinical research, and Regeneron has an exclusive option to negotiate a license to the antibody for future clinical development and commercialization.
September 23, 2015
09:05 EDTAGNAmgen and Allergan's lung cancer biosimilar candidate meets Phase 3 endpoints
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