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June 23, 2014
07:52 EDTSRPT, INO, BMRN, ALNY, SGMO, IDRA, BLUE, AGTC, ISIS, CLDN, ARWRPiper 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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July 27, 2015
10:40 EDTSRPT, ISIS, BLUEIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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08:10 EDTINOInovio initiates clinical trial of INO-5150 DNA immunotherapy
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08:05 EDTALNYAlnylam initiates Phase 1/2 clinical trial for ALN-AAT
Alnylam Pharmaceuticals (ALNY) has initiated a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease. The Phase 1/2 trial will be conducted initially in normal healthy volunteers, and, then, in patients with alpha-1 liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive Disease Week meeting May 16 – 19, 2015. The company expects to present initial clinical data from this trial in early 2016. ALN-AAT is a subcutaneously administered investigational RNAi therapeutic that utilizes Alnylam’s proprietary ESC-GalNAc-siRNA conjugate delivery technology. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. As per the filed CTA, the Phase 1/2 trial of ALN-AAT is a randomized, single-blind, placebo-controlled study being conducted in three parts. Parts A and B are single-dose and multi-dose, dose-escalation studies, designed to enroll up to a total of 48 healthy adult volunteers. Part C will be a multi-dose study designed to enroll up to a total of 24 adults with alpha-1 liver disease and mild-to-moderate liver fibrosis. The primary objective of the study is to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-AAT. Secondary objectives include evaluation of pharmacokinetics and clinical activity for ALN-AAT as measured by knockdown of serum AAT. In addition, biopsies will be obtained from subjects with alpha-1 liver disease to quantify the effects of treatment on levels of periodic acid-Schiff-stained globules, a measure of misfolded AAT accumulation observed in the livers of alpha-1 liver disease patients. In January 2014, Alnylam and Genzyme, a Sanofi (SNY) company, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam's current and future Genetic Medicines pipeline, including ALN-AAT, in the rest of the world. In certain defined instances, Genzyme has co-development/co-commercialization and/or global product rights. Genzyme's rights are structured as an opt-in that is triggered upon achievement of human proof-of-principle.
07:07 EDTISISIsis Pharmaceuticals announces results from ISIS-TTRRx study
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July 23, 2015
08:18 EDTINOInovio, EORTC to collaborate on Phase 2 cervical cancer trial
Inovio announced it is collaborating with the European Organization for Research and Treatment of Cancer, or EORTC, to evaluate Inovio's immunotherapy, INO-3112, in combination with traditional chemo-radiotherapy for the treatment of patients with locally advanced stage cervical cancer. The trial, primarily funded by the EORTC, is expected to begin by the end of the year. A partnership with the EORTC will offer Inovio clinical trial efficiency and speed in recruiting patients in Europe and in obtaining and analyzing results. The EORTC encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. EORTC is the only organization which carries out clinical studies throughout Europe for all types of cancer. Collaboration with the EORTC also leverages their connections to a network of more than 2,500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries.
07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
19:26 EDTISISIsis Pharmaceuticals announces positive clinical data of ISIS-APO(a)Rx published
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17:06 EDTSRPTSarepta announce publication of Phase I clinical data of AVI-7288
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10:01 EDTAGTCOn The Fly: Analyst Initiation Summary
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08:21 EDTAGTCApplied Genetic initiated with a Buy at Chardan
Target $25.
July 21, 2015
07:59 EDTBMRNBioMarin gene therapy an overhang for Baxalta, says JPMorgan
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07:13 EDTISISIsis Pharmaceuticals initiates Phase 1/2a clinical study of ISIS-HTT Rx
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July 20, 2015
14:32 EDTBMRN, SRPTFDA panel likely to review Sarepta, BioMarin drugs in November, TheStreet says
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11:03 EDTBMRN, SRPTSarepta rises after Roth says added data can keep it ahead of BioMarin
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10:13 EDTSRPTOptions with decreasing implied volatility
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08:47 EDTBMRNBioMarin reports Abrazo Phase 2 trial met threshold for tumor reduction
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08:05 EDTALNYAlnylam initiates Phase 3 open label extension study with patisiran
Alnylam announced that it has initiated its Phase 3 open-label extension study, abbreviated APOLLO-OLE, with patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis in patients with Familial Amyloidotic Polyneuropthy. All patients who complete the APOLLO Phase 3 trial with patisiran are eligible to enroll in APOLLO-OLE. The study will evaluate the long-term safety and efficacy of patisiran and will also measure effects of treatment toward a number of clinical endpoints, including the modified Neuropathy Impairment Score, or “mNIS+7,” which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance. The company is also reiterating its previous guidance that – assuming positive study results in the APOLLO Phase 3 study – it expects to be in a position to file a New Drug Application for patisiran in the 2017 timeframe.
July 16, 2015
10:18 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ENR FOSL KING
July 14, 2015
18:08 EDTBLUEImmuno-oncolgy stocks advance after Receptos acquired by Celgene
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07:05 EDTISISIsis Pharmaceuticals earns $2.15M milestone payment from Biogen
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