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March 5, 2014
13:02 EDTNVS, RHHBY, MRK, ARWR, BMYAnalyst: Arrowhead Research could be in early stages of major run, Barron's says
RBC analyst Michael Yee believes Arrowhead Research is in the early innings of a potentially major run, according to Barron's. Yee cites the company's promising lead drug for Hep B, its RNAi platform technology, and the fact that it could partner with larger firms such as Roche (RHHBY), Bristol Myers (BMY), Merck (MRK), and Novartis (NVS).Reference Link
News For ARWR;RHHBY;BMY;MRK;NVS From The Last 14 Days
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November 18, 2015
07:01 EDTMRKThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.
November 17, 2015
16:38 EDTNVSAduro Biotech to delay filing 10-Q
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10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
08:04 EDTMRKMerck to present new KEYTRUDA findings at upcoming congresses
Merck announced that data investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research 2015 Congress in San Francisco, Nov. 18 - 21; the 57th American Society of Hematology Annual Meeting in Orlando, Florida, Dec. 5 - 8; the San Antonio Breast Cancer Symposium, Dec. 8 - 12; and the European Society for Medical Oncology Asia 2015 Congress in Singapore, Dec. 18 - 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. "The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."
07:34 EDTNVS, RHHBYOphthotech to hold a conference call
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06:08 EDTRHHBY, NVSRoche subsidiary to participate in Ophthotech and Novartis agreement
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05:24 EDTNVSNovartis announces Phase III FLAME head-to-head trial met primary endpoint
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November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
11:09 EDTARWRArrowhead says data shows ARC-520 can produce reductions of HBV antigens
Arrowhead Research Corporation presented data from a Phase 2a clinical study at The AASLD Liver Meeting 2015 demonstrating that ARC-520, its lead drug candidate against chronic hepatitis B infection, effectively reduced HBV viral antigens derived from cccDNA. HBV surface antigen was reduced substantially with a maximum reduction of 1.9 logs and a mean maximum reduction of 1.5 logs in treatment naive e-antigen-positive patients. This direct antiviral effect was still evident 57 days after a single dose. These data strongly support advancement of ARC-520, and Arrowhead has initiated multiple studies aimed at producing a functional cure of HBV. In this presentation, Dr. Yuen and co-authors show that in the Heparc-2001 clinical study, ARC-520 in combination with entecavir achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and core-related antigen of 1.9 logs, 4.3 logs, 1.7 logs, and 1.2 logs, respectively. Consistent with findings from Arrowhead's chimpanzee study, also presented at AASLD, variations in viral antigen reduction indicated that patients previously treated with chronic entecavir and patients that were treatment-naive and negative for HBeAg likely had lower levels of cccDNA derived mRNA transcripts. As such, HBeAg-positive treatment naive patients experienced a greater relative reduction in HBsAg than patients that were HBeAg-negative or treatment experienced. One transitional patient in cohort 7 was HBeAg-positive at baseline and became HBeAg-negative at days 3 to 43. This patient experienced an intermediate response initially, however HBsAg continued to trend downward through day 57, the last time-point available. ARC-520 was well tolerated with no serious adverse events, no dose limiting toxicities, no discontinuations due to medication AEs, and a modest occurrence rate of AEs that were all deemed unrelated to study drug by the principal investigator. No AE occurred more than once. There were no AEs amongst 10 patients receiving placebo. There was a low occurrence rate of abnormal laboratory tests, with no observed relationship to timing or dose.
08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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08:27 EDTARWRArrowhead to hold an analyst and investor reception
Management hosts an Analyst and Investor Reception to discuss ARC-520 and key data presented at the 66th Annual Meeting of AASLD in San Francisco on November 16 at 9:30 pm. Webcast Link
07:24 EDTMRKSalomon to hold a conference
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07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 15, 2015
18:28 EDTARWRArrowhead reports data on anti-hepatitis B effects of ARC-520 in chimpanzees
Arrowhead announced the presentation of data demonstrating that ARC-520, its drug candidate against chronic hepatitis B infection, leads to "robust, sustained anti-viral effects in chimpanzees with chronic HBV," according to the company. Arrowhead also reported a new discovery that HBV DNA integrated into the host genome is "likely an important source of HBV surface antigen production, particularly in chimps that are negative for hepatitis B e-antigen." ARC-520 led to a drop in circulating HBsAg, with the degree of HBsAg reduction correlating with HBeAg status. HBeAg-positive and negative chimps demonstrated HBsAg reductions of 96.8%-99.8% and 68.4%-87.4%, respectively, with an intermediate response in a chimp transitioning from HBeAg positive to negative. In addition, one chimp seroconverted for HBeAg during ARC-520 therapy and had a sustained virologic response with respect to HBeAg, HBV DNA, and HBsAg. This persisted off therapy and through at least 32 weeks after ARC-520 and NUC therapy was removed. A second chimp demonstrated effects consistent with immunologic reactivation. Arrowhead also found that the predominant form of liver HBV DNA differed in HBeAg-negative versus HBeAg-positive chimps. Most HBV DNA in HBeAg-positive chimps was cccDNA, while less than 5% of HBV DNA in HBeAg-negative chimps was cccDNA. In addition, HBV RNA profiles in HBeAg-negative chimps were consistent with transcripts arising from integrated DNA. "These data and others, strongly suggest that integrated DNA is likely an important source of HBsAg production in HBeAg-negative chimps," claimed the company. "Direct confirmatory data" was obtained by treating HBeAg negative chimps with a siRNA designed to target transcripts originating from integrated HBV DNA. Up to an additional 99% of HBsAg knockdown was achieved, resulting in overall relative knockdown levels similar to those observed using ARC-520 in HBeAg-positive chimps. Arrowhead said it has incorporated one of these RNAi triggers and one targeting predominantly cccDNA derived transcripts into a new complementary drug candidate, ARC-521, that is planned to be in clinical trials in 2016. The company noted it plans to present additional data at the Hep Dart conference in December demonstrating that two of four HBeAg-positive chimps exhibited signs of immune reactivation, "which is believed to be a necessary step toward achieving a functional cure of HBV."
15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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November 13, 2015
10:18 EDTRHHBYRoche receives FDA approval for cobas EGFR mutation test
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09:34 EDTRHHBYFDA approves Roche's cobas EGFR Mutation Test
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08:28 EDTARWRAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
08:02 EDTMRKMerck: DMC recommends anacetrapib study continue with no changes
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