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May 14, 2014
Boston Biopharma Bus Tour travels throughout Boston on May 14-16.
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October 2, 2014
08:15 EDTXLRNAcceleron added to Top Picks list at FBR Capital
FBR Capital added Acceleron to its Top Picks list calling the stock its top biotechnology pick into the fall medical conference season. FBR expects visibility to increase into the company's anemia management using a novel class of drugs targeting the TGF-beta pathway. It has an Outperform rating on the name with a $47 price target.
07:36 EDTARIAARIAD AP26113 receives Breakthrough Therapy designation from FDA
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October 1, 2014
08:06 EDTALNYAlnylam initiates EXPLORE trial
Alnylam Pharmaceuticals and collaborators from the American Porphyria Consortium and The European Porphyria Network have initiated the EXPLORE trial, a prospective observational study of patients with hepatic porphyrias, including Acute Intermittent Porphyria, Variegate Porphyria, and Hereditary Coproporphyria, suffering from recurrent attacks. With this study, Alnylam and clinical investigators aim to learn more about the clinical course, management, and disease burden of patients with hepatic porphyrias that suffer from recurrent attacks. Alnylam is currently advancing ALN-AS1, a subcutaneously administered investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of hepatic porphyrias, and expects to file an IND or IND equivalent in late 2014 or early 2015. EXPLORE is a prospective, multi-center observational study designed to enroll up to 100 patients with hepatic porphyrias and a history of recurrent attacks. The study’s primary objective is to characterize the natural history, clinical management, and disease burden of patients with hepatic porphyrias. The study’s secondary objectives are to further characterize a number of disease features of hepatic porphyrias, including: (i) signs and symptoms of porphyria during acute attacks; (ii) levels of plasma and urinary aminolevulinic acid and porphobilinogen, the toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of the acute hepatic porphyrias; (iii) expression levels of aminolevulinic acid synthase-1 during acute attacks; and (iv) medical and family history of hepatic porphyria patients. Data obtained from EXPLORE are expected to further the understanding of hepatic porphyrias and to assist the design of clinical trials with ALN-AS1.
07:32 EDTEPZMEpizyme to present EPZ-6438 clinical data from Phase 1 trial
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07:28 EDTXLRN, ALNYLeerink to hold a roundtable
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September 29, 2014
09:48 EDTALKSAlkermes management to meet with Leerink
Meetings to be held in Canada October 6-7 hosted by Leerink.
07:36 EDTARIAARIAD presents updated clinical data on AP26113
ARIAD Pharmaceuticals announced updated clinical results on its investigational tyrosine kinase inhibitor, AP26113, in patients with advanced non-small cell lung cancer from an ongoing Phase 1/2 trial. These study results show sustained anti-tumor activity of AP26113 in patients with anaplastic lymphoma kinase positive NSCLC, including patients with active brain metastases. The updated Phase 1/2 trial now contains more mature data of AP26113, including increasing depth and durability of response in ALK+ NSCLC patients, as well as additional safety data. The updated results were presented on Saturday, September 27 at the 2014 European Cancer Congress held in Madrid, Spain. A total of 137 patients have been enrolled in the ongoing Phase 1/2 trial in the United States and Europe. The objectives of the Phase 1 portion of the trial were to characterize the safety and tolerability of AP26113, pharmacokinetics, and preliminary anti-tumor activity and to determine the recommended dose for further study of AP26113 in subsequent clinical trials. The trial used an open-label, dose-escalating design. The Phase 2 portion of the trial consists of five expansion cohorts. The data presented at ESMO focus on the 79 patients with a history of ALK+ NSCLC tumors in the entire trial. Fifty-six of these patients currently remain on study treatment.
September 26, 2014
07:34 EDTAGIOAgios Pharmaceuticals presents AG-120 ongoing Phase 1 study data
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07:32 EDTALNYBioCentury to hold a conference
21st Annual NewsMakers in the Biotech Industry Conference to be held in New York on September 26.
September 25, 2014
10:16 EDTAGIOAgios Pharmaceuticals management to meet with Leerink
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September 24, 2014
09:52 EDTALKSAlkermes expects to receive $59M in connection to Acorda-Civitas deal
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08:08 EDTALNYAlnylam initiates DISCOVERY trial
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September 23, 2014
08:33 EDTXLRNAcceleron provides update on clinical trial of dalantercept monotherapy
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September 22, 2014
16:02 EDTTSROTESARO files to sell $165M of convertible senior notes due 2021
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05:57 EDTXLRNAcceleron to host webinar
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September 19, 2014
09:05 EDTIMGNImmunoGen discloses Chief Medical Officer James O'Leary's intention to leave
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September 18, 2014
17:57 EDTARIAARIAD CEO buys 25K shares of company stock
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09:31 EDTXLRNAcceleron management to meet with JMP Securities
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07:49 EDTALNYAlnylam resumed with an Outperform at Leerink
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