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Stock Market & Financial Investment News

News Breaks
June 9, 2014
09:22 EDTAZN, NSR, ADI, FDO, IDIX, CGIX, TSN, HITT, MRK, ODP, ALNY, HSH, DG, ACHNOn The Fly: Pre-market Movers
HIGHER: Idenix (IDIX), up more than 230% after Merck (MRK) acquires the company for $24.50 per share in cash of $3.85B. Idenix peer Achillion (ACHN) is up 35% after Merck's purchase... Hittite Microwave (HITT), up 29% after Analog Devices (ADI) agrees to acquire the company for $78 per share in cash... Family Dollar (FDO), up 11.6% following upgrade at Jefferies after Carl Icahn reported a 9.4% stake in the company. Dollar General (DG), which is being seen as potentially urged as a merger target for Family Dollar based on Icahn's stake, is up 8.6% after the news... Hillshire Brands (HSH), up 4.7% after Tyson Foods (TSN) submits unilaterally binding offer to acquire the company for $8.55B... Office Depot (ODP), up 4.6% after Barron's says shares could jump over 50%... Cancer Genetics (CGIX), up 6.4% after announcing partnership with AstraZeneca (AZN). LOWER: NeuStar (NSR), down 6.3% after calling FCC posting of confidential email "troubling"... Alnylam (ALNY), down 5.8% after presenting ALN-CC5 new pre-clinical data.
News For IDIX;ACHN;MRK;FDO;DG;HITT;ADI;HSH;TSN;NSR;ALNY;CGIX;AZN;ODP From The Last 14 Days
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July 27, 2015
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.
07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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05:25 EDTAZNGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 24, 2015
08:02 EDTCGIXCancer Genetics suspends active on 'at-the-market' equity
Cancer Genetics announced that it has suspended activity on the sale of shares through an "at-the-market" offering.
08:02 EDTCGIXCancer Genetics suspends at-the-market equity offering
06:53 EDTODPAmazon urges FTC to approve Staples-Office Depot deal, NY Post says
Amazon (AMZN) founder and CEO Jeff Bezos has reached out to FTC regulators through intermediaries supporting approval of Staples' (SPLS) proposed $6.3B offer to acquire Office Depot (ODP), the New York Post reports, citing sources familiar with the matter. Reference Link
July 23, 2015
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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07:31 EDTCGIXRedChip to hold a virtual conference
2015 Global Online CEO Conference is being held on July 22-23 with webcasted presentations to begin on July 23 at 9:30 am. Webcast Link
07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
14:51 EDTADIEarnings Watch: Qualcomm reports after speculations of potential breakup
Qualcomm (QCOM) is expected to report third quarter earnings after the close on July 22, with a conference call scheduled for 4:45 pm ET. Qualcomm is a maker of semiconductors and telecommunications equipment. EXPECTATIONS: Analysts are looking for earnings per share of 95c on revenue of $5.85B. EPS consensus ranges 90c-$1.05 on a revenue range of $5.59B-$6.08B, according to First Call. LAST QUARTER: On April 22, Qualcomm reported Q2 EPS of $1.40 against expectations for $1.33, and revenue of $6.89B versus estimates of $6.83B. The company also cut its FY15 EPS guidance to $4.60-$5.00 from $4.85-$5.05 and lowered projected revenue to $25B-$27B from $26.3B-$28B, saying it expects pressure in its semiconductor business due to customer shifts in the premium segment and a decline in Qualcomm's share at an unnamed large customer. NEWS: On May 8, Reuters reported that EU antitrust regulators asked Qualcomm's competitors how the company's licensing and business practices affect them, and on July 16, the European Commission confirmed two formal antitrust investigations of the company. On May 25, Qualcomm and Daimler (DDAIF) announced a strategic collaboration to develop connected car technology. Coming on the heels of Avago's (AVGO) May 28 agreement to acquire Broadcom (BRCM), Bloomberg quoted a source later that day as saying Qualcomm, Intel (INTC), Altera (ALTR), Analog Devices (ADI), Maxim Integrated (MXIM), Texas Instruments (TXN), and Microchip Technology (MCHP) are all considering their own M&A opportunities. Note that on June 1, Intel announced an agreement to acquire Altera. On June 23, Semiconductor Manufacturing International (SMI), Qualcomm, Huawei, and Imec announced the formation of a joint venture to focus on a type of 14 nanometer technology. More recently, the Wall Street Journal reported on July 20 that Qualcomm is "expected" to begin a comprehensive strategic review which may include the possibility of a breakup following pressure from "activist" shareholder Jana Partners, according to sources, adding that the move could be announced concurrent with Wednesday's earnings release. STREET RESEARCH: Following last quarter's earnings report, Exane BNP Paribas downgraded Qualcomm to Neutral from Outperform, while both Canaccord and Brean Capital lowered price targets for the stock after "disappointing" guidance. Meanwhile, Citi said it expects the company's chip business to recover in 2016 despite this "very bad year." On May 28, CLSA said it sees continued pressure on Qualcomm chipsets, potentially spurring the company to consider making an acquisition, and on June 2, Craig-Hallum noted that Skyworks (SWKS) would be a great fit for Qualcomm. On June 24, Summit Research called Applied Micro Circuits (AMCC) an "affordable" target for Qualcomm, with AMD (AMD) and Cavium (CAVM) also looking like potential takeover candidates. On June 29, Drexel Hamilton downgraded Qualcomm to Sell from Hold, citing expected price cuts. Lastly, following media reports on July 20 that Qualcomm could be weighing a breakup, Bernstein said that such a "dis-synergistic" split would likely destroy value rather than create it. PRICE ACTION: Shares of Qualcomm are down more than 1% to $64.37 in afternoon trading ahead of Wednesday's earnings report.
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
12:35 EDTADIAnalog chip makers fall after Linear cites weak end market demand
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10:01 EDTADIOn The Fly: Analyst Downgrade Summary
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09:28 EDTADIAnalog Devices downgraded to Hold from Buy at Drexel Hamilton
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09:07 EDTAZNOn The Fly: Pre-market Movers
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07:20 EDTCGIXRedChip to hold a virtual conference
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
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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