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News Breaks
February 8, 2013
09:37 EDTMSI, ZBRA, PCYC, ALNY, CENT, MUX, PAY, ONXX, CELG, CAP, ARIA, VSTM, MDR, AFFYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Affymax (AFFY) initiated with an Outperform at JMP Securities... Alnylam (ALNY) initiated with an Outperform at JMP Securities... Celgene (CELG) initiated with an Outperform at JMP Securities... DSW (DSW) initiated with a Buy at Sterne Agee... McDermott (MDR) initiated with a Neutral at HSBC... Onyx Pharmaceuticals (ONXX) initiated with an Outperform at JMP Securities... Pharmacyclics (PCYC) initiated with an Outperform at JMP Securities... Verastem (VSTM) initiated with an Outperform at JMP Securities... VeriFone (PAY) initiated with a Hold at Jefferies... sZebra Technologies (ZBRA) initiated with a Market Perform at Wells Fargo... ARIAD (ARIA) initiated with an Outperform at JMP Securities... McEwen Mining (MUX) initiated with a Buy at Stifel Nicolaus... Motorola Solutions (MSI) initiated with an Outperform at Wells Fargo... CAI International (CAP) initiated with an Outperform at Wells Fargo... Central Garden & Pet (CENT) initiated with a Neutral at SunTrust.
News For AFFY;CELG;ALNY;MDR;ONXX;PCYC;VSTM;PAY;ZBRA;ARIA;MUX;MSI;CAP;CENT From The Last 14 Days
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July 28, 2015
16:02 EDTCAPCAI International reports Q2 adjusted EPS 63c, consensus 68c
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10:15 EDTVSTMVerastem management to meet with Mizuho
Meetings to be held in the Midwest July 28-29 hosted by Mizuho.
07:31 EDTCELGCelgene commences tender offer for Receptos
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07:25 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
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July 27, 2015
10:40 EDTCELGIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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08:38 EDTCELGAnalysts divided on Biogen following $85 selloff
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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.
July 24, 2015
08:08 EDTCELGCelgene price target raised to $190 from $156 at Canaccord
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July 23, 2015
19:50 EDTCELGCelgene price target raised to $163 from $146 at Cantor
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10:50 EDTCELGCelgene positioned for sustainable growth, says Piper Jaffray
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07:37 EDTCELGCelgene reports Q2 Revlimid sales up 19% to $1.44B
ABRAXANE® sales for the second quarter were $244 million, a 13 percent increase. POMALYST®/IMNOVID® sales for the second quarter were $235 million, an increase of 46%. VIDAZA® sales in the second quarter remained flat year-over-year at $152 million. OTEZLA® sales for the second quarter were $90 million, increasing 49 percent over the first quarter of 2015.
07:37 EDTCELGCelgene raises FY15 adjusted EPS view to $4.75-$4.85 from $4.60-$4.75
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07:32 EDTCELGCelgene reports Q2 adjusted EPS $1.23, consensus $1.20
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07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
15:26 EDTCELGNotable companies reporting before tomorrow's open
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09:28 EDTCELGBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
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July 21, 2015
11:03 EDTCELGCelgene treatment of pediatric Crohn's disease receives FDA orphan designation
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06:29 EDTCELGCelgene price target raised to $160 from $147 at Piper Jaffray
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06:24 EDTCELGPiper expects 'stronger, bolder' move from Biogen
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July 20, 2015
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.
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