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June 23, 2014
07:52 EDTSGMO, IDRA, BLUE, AGTC, ISIS, CLDN, ARWR, SRPT, INO, BMRN, ALNYPiper Jaffray to hold a symposium
GenomeRX Symposium to be held in New York on June 23.
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November 18, 2015
06:30 EDTBMRNBioMarin assumed with a Buy at Goldman
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06:24 EDTBLUEbluebird bio initiated with a Buy at Goldman
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November 17, 2015
16:10 EDTBMRNBioMarin initiated with a Perform at Oppenheimer
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08:44 EDTSRPTSarepta says eteplirsen study shows 'positive' results
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November 16, 2015
11:49 EDTBLUELate-breaker ASH abstract to drive interest in bluebird, says Cowen
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11:30 EDTBLUEbluebird bio ASH late-breaker abastract data a positive, says Wedbush
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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.
08:27 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 EDTINOSalomon to hold a conference
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07:22 EDTINOBrean Capital to hold a summit
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07:16 EDTBMRNHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
07:16 EDTSRPT, BMRNFDA likely feels compelled to approve at least one DMD drug, says Leerink
Leerink analyst Joseph Schwartz says the FDA likely feels compelled to approve at least one of the exon skipping drugs to treat Duchenne muscular dystrophy in this review cycle. There is so much public attention and vocal demand in the DMD community, Schwartz tells investors in a research note. The FDA advisory panel on BioMarin's (BMRN) drisapersen is on November 24 while the panel on Sarepta's (SRPT) eteplirsen is tentatively scheduled for January 22, 2016. The greatest likelihood is that both drugs are approved, Schwartz contends. Shares of BioMarin have "significant" upside potential on a positive panel vote as many investors still doubt that drisapersen is approvable based on existing data, and approval would "greatly aid" the company's goal to reach profitability, the analyst argues. He reiterates an Outperform rating on BioMarin and a Market Perform rating on Sarepta. Jefferies analyst Eun Yang said on Friday that regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin.
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."
November 13, 2015
15:32 EDTBMRN, SRPTSarepta CEO says having BioMarin go first with AdCom is an advantage
Sarepta (SRPT) interim CEO Edward Kaye said BioMarin (BMRN) having to go first with its advisory committee meeting for its own DMD drug will allow Sarepta time to assess the committee's comments and questions on their drug and formulate responses. Kaye is speaking on CNBC.
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.
07:57 EDTBMRN, SRPTExperts see positive FDA panel for BioMarin, says Jefferies
Jefferies analyst Eun Yang says regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin's (BMRN) Kyndrisa, a treatment for Duchenne Muscular Dystrophy. The panel meeting is November 24 and the FDA action date for the drug is December 27. The experts point to a favorable risk/benefit profile for Kyndrisa as well as no current treatment option for DMD as supporting their confidence of FDA approval, Yang tells investors in a research note. The experts see a post-marketing study for Kyndrisa as likely necessary, she adds. On competitor Sarepta's (SRPT) DMD treatment eteplirsen, experts' views are "somewhat mixed," Yang adds. She has a Buy rating on BioMarin with a $166 price target. A positive panel vote could boost shares by 20% and bring increased confidence in BioMarin's three additional candidates targeting additional DMD patients, she contends. The orphan drug developer closed yesterday down $4.35 to $106.80.
November 11, 2015
10:46 EDTALNYAlnylam and The Medicines Co. reports trial results with ALN-PCSsc
Alnylam (ALNY) and The Medicines Company (MDCO) reported results from their ongoing Phase 1 clinical trial with ALN-PCSsc in an oral presentation at the American Heart Association Scientific Sessions 2015. ALN-PCSsc is an investigational RNAi therapeutic targeting PCSK9 - a genetically validated protein regulator of LDL receptor metabolism - being developed for the treatment of hypercholesterolemia. As reported previously, subcutaneous administration of ALN-PCSsc resulted in an up to 83% lowering of LDL-C, with an up to 64 +/- 5 percent mean maximum reduction, comparable to published results for anti-PCSK9 MAbs. In new results, the effects of ALN-PCSsc were found to be highly durable, with clinically significant and clamped reductions in LDL-C, supportive of a potential bi-annual subcutaneous dose regimen. Specifically, an up to 53 percent maximal and 47% least squares mean reduction in LDL-C was achieved at day 180 after just a single, low volume injection. In addition, ALN-PCSsc was shown to reduce a number of atherogenic lipids, including lipoprotein - or "Lp" - and total cholesterol, which are associated with increased risk of cardiovascular disease. ALN-PCSsc was generally well tolerated with no clinically significant drug-related adverse events. The development leadership of ALN-PCSsc has now transferred from Alnylam to The Medicines Company, who expects to initiate the ORION-1 Phase 2 study by the end of 2015.
November 10, 2015
14:39 EDTALNYThe Medicines Co. and Alnylam Pharmaceuticals hold a joint conference call
Alnylam and The Medicines Company hold a joint conference call to discuss ALN-PCSsc results on November 11 at 4:30 pm. Webcast Link
07:03 EDTISISIsis Pharmaceuticals earns $2.8M milestone payment from Biogen
Isis Pharmaceuticals (ISIS) announced that it has earned a $2.8M milestone payment from Biogen (BIIB) related to the advancement of the ongoing Phase 1/2a study of ISIS-DMPK-2.5Rx in patients with myotonic dystrophy type I, or DM1. ISIS-DMPK-2.5Rx is designed to reduce the production of the toxic dystrophia myotonica-protein kinase RNA in cells, including muscle cells, for the potential treatment of DM1.
06:03 EDTALNYPiper sees Biotech fundamentals as 'strong' despite pricing chatter
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