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News Breaks
June 23, 2014
07:52 EDTISIS, CLDN, ARWR, SRPT, INO, BMRN, ALNY, SGMO, IDRA, BLUE, AGTCPiper Jaffray to hold a symposium
GenomeRX Symposium to be held in New York on June 23.
News For AGTC;ALNY;ARWR;BLUE;BMRN;CLDN;IDRA;INO;ISIS;SGMO;SRPT From The Last 14 Days
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November 20, 2014
15:14 EDTSRPTTraveler returned from Mali being tested for Ebola in NYC, Daily News reports
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08:03 EDTINOInovio's melanoma immunotherapy shows positive preclinical survival results
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07:24 EDTISISGoldman to hold a conference
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06:40 EDTISISIsis Pharmaceuticals price target raised to $62 from $53 at Piper Jaffray
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November 19, 2014
07:52 EDTALNYInforma Business Information to hold a conference
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07:08 EDTSGMOSangamo says study demonstrates in vivo reversal of Huntington's disease signs
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November 18, 2014
15:48 EDTISISGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
09:17 EDTSRPTSarepta announces first patient dosed in Eteplirsen study
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07:37 EDTIDRAStifel to hold a conference
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07:32 EDTARWRArrowhead files for regulatory permission to begin Phase I ARC-AAT trial
Arrowhead Research recently filed an application for approval to begin a Phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-AAT, for the treatment of liver disease associated with alpha-1 antitrypsin deficiency. Pending approval, Arrowhead intends to proceed with a double blind, placebo-controlled dose escalation, Phase 1 study to determine the safety, tolerability, pharmacokinetics and effect on circulating alpha-1 antitrypsin levels of ARC-AAT in healthy volunteers and patients with alpha-1 antitrypsin deficiency. The study is planned to start in Australia in healthy volunteers and will dose escalate until predetermined levels of alpha-1 antitrypsin reduction are reached. Once these levels of protein knockdown are achieved, the study will transition into a population of patients with ZZ genotype alpha-1 antitrypsin deficiency to further evaluate escalating doses of ARC-AAT. The study is designed to enroll up to 48 subjects, including healthy volunteers and alpha-1 antitrypsin deficiency patients. The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.
November 17, 2014
17:03 EDTALNYAlnylam presents new pre-clinical data on RNAi therapeutic programs
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11:49 EDTSGMO, BLUEPiper Jaffray healthcare analysts to hold an analyst/industry conference call
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09:22 EDTINOOn The Fly: Pre-market Movers
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08:44 EDTSRPTNebraska Medical announces death of third Ebola patient
The Nebraska Medical Center said via Twitter, "We are sorry to announce that the 3rd Ebola patient, Dr. Martin Salia, has passed away as a result of the advanced symptoms of the disease." Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED).
07:16 EDTBLUEMilken Institute--Faster Cures to hold a conference
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07:09 EDTALNYAmerican Heart Association to hold a conference
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05:30 EDTINOInovio, Roche terminate collaboration for INO-5150
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November 14, 2014
15:41 EDTISISIsis Pharmaceuticals management to meet with Piper Jaffray
Meeting to be held in Kansas City, MO on November 18 hosted by Piper Jaffray.
06:31 EDTALNYAlnylam to host conference call
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06:04 EDTALNYAlnylam announces positive initial phase 2 data with Revusiran
Alnylam announced positive initial Phase 2 data with revusiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR cardiac amyloidosis. In the pilot Phase 2 study, revusiran was found to be generally well tolerated in TTR cardiac amyloidosis patients. Revusiran demonstrated clinical activity with an up to 98.2% knockdown of serum TTR – the disease causing protein. This included similar knockdown effects toward wild type and mutant TTR protein within V122I patients, who represent the most common genotype associated with inherited forms of TTR cardiac amyloidosis. In the five week course of treatment, there were no significant changes observed in a number of exploratory clinical measurements. Revusiran utilizes Alnylam’s proprietary GalNAc-conjugate delivery platform that enables subcutaneous delivery of RNAi therapeutics with a wide therapeutic index. The primary objective of the study was to evaluate the safety and tolerability of revusiran. The secondary objectives were to assess the clinical activity of revusiran toward serum levels of TTR and characterize the drug’s pharmacokinetic profile. In addition, a number of exploratory clinical measurements were performed at baseline and days 42 and 90 after start of dosing.
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