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News Breaks
March 10, 2014
04:55 EDTEXEL, EXEL, EXEL, AGIO, AGIO, AGIO, ALNY, ALNY, ALNY, EPZM, EPZM, EPZM, INFO, INFO, INFO, VRTX, VRTX, VRTX, FMI, FMI, FMIBernstein to hold a conference
Emerging Biotech Conference 2014 is being held in Snowbird, Utah on March 10-12.
News For EXEL;AGIO;ALNY;EPZM;INFO;VRTX;FMI From The Last 14 Days
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November 20, 2014
07:38 EDTEXELThe Federal Energy Regulatory Commission (FERC) to hold a meeting
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07:24 EDTFMIGoldman to hold a conference
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07:13 EDTFMICanaccord to hold a forum
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06:33 EDTEPZMEpizyme to host conference call
Conference call to discuss results from the Phase 1 dose escalation study of the investigational EZH2 inhibitor EPZ-6438 will be held on November 20 at 8 am. Webcast Link
November 19, 2014
18:06 EDTEPZMEpizyme reports results from Phase 1 dose study of EZH2 inhibitor EPZ-6438
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13:42 EDTVRTXVertex peak CF sales have bullish read from Royalty Pharma bet, TheStreet says
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10:42 EDTVRTXUBS hosts a conference call with Vertex Pharmaceuticals
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09:16 EDTAGIOOn The Fly: Pre-market Movers
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09:02 EDTAGIOAgios Pharmaceuticals to host conference call
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08:18 EDTAGIOAgios Pharmaceuticals price target raised to $111 from $97 at Canaccord
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07:52 EDTALNY, VRTXInforma Business Information to hold a conference
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07:27 EDTVRTXRoyalty Pharma acquires royalties on Vertex Pharmaceuticals CF treatments
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November 18, 2014
18:05 EDTAGIOAgios Pharmaceuticals reports early Phase 1 data from AG-120 trial
Agios Pharmaceuticals announced the first reported safety and clinical activity for AG-120 from the ongoing Phase 1 dose escalation study in patients with IDH1-mutant positive advanced hematologic malignancies, including acute myeloid leukemia. Agios has exclusive U.S. development and commercial rights to AG-120, a first-in-class, oral, selective, potent inhibitor of the mutant IDH1 enzyme. Daniel Pollyea, M.D., clinical investigator at the University of Colorado School of Medicine, will present the data in a late-breaking oral presentation at the 26th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held in Barcelona, Spain. The company will webcast an investor conference call from the symposium at 10:00 a.m. EST on Wednesday, November 19. As of October 17, the ongoing Phase 1 trial for AG-120 had enrolled 17 patients with a documented IDH1 mutation whose cancer relapsed or failed to respond to at least one prior treatment regimen. At the time of the data cut, 14 patients with relapsed and/or refractory AML were evaluable; three patients recently initiated therapy and were not evaluable. The initial data showed investigator assessed objective responses in seven out of 14 evaluable patients, including four complete remissions, with responses observed across the four dose levels tested, and early evidence of durability. One additional patient remains stable on study. AG-120 was well tolerated, with the majority of adverse events reported as mild to moderate. The maximum tolerated dose has not yet been reached. One patient had a dose limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested to date, which improved to grade 1 after AG-120 dose reduction according to treatment protocol. This patient is in complete remission and remains on AG-120. AG-120 showed favorable drug exposure and pharmacokinetics at all doses tested and also substantially reduced plasma levels of the oncometabolite 2-hydroxyglutarate, which is produced by the mutant IDH1 protein, to the level observed in healthy volunteers. The mechanism of response is consistent with differentiation, as evidenced by the maturation of the leukemic cells into infection fighting white blood cells, or neutrophils. Based on these findings, the company plans to initiate multiple expansion cohorts in the first half of 2015.
07:20 EDTAGIO, EPZMEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
17:03 EDTALNYAlnylam presents new pre-clinical data on RNAi therapeutic programs
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07:20 EDTFMILeerink to hold a tour
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07:09 EDTALNYAmerican Heart Association to hold a conference
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November 16, 2014
13:12 EDTEXELExelixis announces data from trial of XL888 and vemurafenib
Exelixis announced preliminary results from a phase 1 investigator-sponsored trial, IST, evaluating the safety and activity of XL888, an Exelixis-discovered small molecule oral inhibitor of Heat Shock Protein 90, HSP90, in combination with vemurafenib in patients with unresectable stage III/IV BRAF V600 mutation-positive melanoma. Safety and efficacy results support the further investigation of 90 mg of XL888 twice weekly, BIW and vemurafenib 960 mg twice daily,BID, in additional studies that would include a third agent. The trial results were presented today by Keiran Smalley, Ph.D., an investigator on the trial and an associate professor at H. Lee Moffitt Cancer Center, Tampa, Florida, in a late-breaking oral presentation session at the Society for Melanoma Research 2014 International Congress, which is taking place November 13-16, in Zurich, Switzerland. Based on these results, as well as findings from coBRIM, the phase 3 pivotal trial of cobimetinib, an Exelixis-discovered MEK inhibitor, and vemurafenib in previously untreated metastatic melanoma patients with a BRAF V600 mutation, the Moffitt Center plans to initiate a phase 1b IST of the triple combination of vemurafenib, cobimetinib, and XL888 in a similar patient population. “The BRAF inhibitor vemurafenib is active in BRAF-mutated malignant melanoma, but development of resistance is common. Preclinical studies led by Keiran Smalley, Ph.D. suggested that most BRAF inhibitor resistance mechanisms involve proteins that are clients of HSP90, and the preclinical evaluation of XL888 showed that it is highly active in vemurafenib-resistant melanoma models,” said Jeffrey Weber, MD, Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at the Moffitt Cancer Center and Research Institute in Tampa, FL. “The current phase 1 data show that both drugs can be given together, and compelling initial response results suggest potential cooperative activity.” “About half of metastatic melanoma patients whose tumors harbor a BRAF V600 mutation respond to vemurafenib, but most of them develop resistance and their tumors begin to regrow,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Multiple mechanisms drive this resistance, and the team at Moffitt found that many of them involve upregulation of HSP90 client proteins that are sensitive to XL888. We look forward to supporting the Moffitt team as they continue to evaluate XL888 as part of our IST program.”
November 14, 2014
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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