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Stock Market & Financial Investment News

News Breaks
January 13, 2014
05:10 EDTALNY, MRKAlnylam acquires Sirna Therapeutics from Merck for $175M in cash, equity
Alnylam Pharmaceuticals (ALNY) announced the acquisition of Merck’s (MRK) wholly owned subsidiary Sirna Therapeutics, comprising intellectual property and RNAi assets including pre-clinical therapeutic candidates, chemistry, siRNA-conjugate and other delivery technologies. Under the agreement, in exchange for acquiring the stock of Sirna Therapeutics, Alnylam will pay Merck an upfront payment of $175M in cash and equity, broken down as $25M cash and $150M in Alnylam common stock. In addition, Merck is eligible to receive up to $105M in developmental and sales milestone payments per product, as well as single-digit royalties, associated with the progress of certain pre-clinical candidates discovered by Merck. Merck is also eligible to receive up to $10M in milestone payments and single-digit royalties on Alnylam products covered by Sirna Therapeutics’ patent estate.
News For ALNY;MRK From The Last 14 Days
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July 29, 2015
09:20 EDTMRKMerck recent weakness creates buying opportunity, says Argus
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July 28, 2015
16:53 EDTMRKOn The Fly: Top stock stories for Tuesday
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12:31 EDTMRKOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session in positive territory but turned mixed a short time after the open. The averages gathered themselves again and began an upward drift about an hour into trading, leaving markets near session highs around noon as stocks try to break their string of five consecutive lower closes. ECONOMIC EVENTS: In the U.S., the Case Shiller 20-city home price index rose 1.1% in May to 179.03, missing a forecast for it to rise 1.7% to 180.2. Markit's services PMI for July rose to 55.2, above the expected 55.0 reading. The Richmond Fed factory index rose to 13.0 in July from an upwardly revised 7 in June. Consumer confidence fell to 90.9 in July, down from a revised 99.8 figure for last month and below the expected reading of 100. In China, the Shanghai composite index closed down 1.7%, but only after a volatile session that saw it down as much as 5.1% and up about 1% at different points in the trading day. In Europe, U.K. GDP growth in the second quarter came in at 0.7%, matching the consensus expectation. COMPANY NEWS: Earnings season continued in earnest with UPS (UPS), Ford (F), Pfizer (PFE) and Merck (MRK) each reporting better than expected quarterly profits. UPS, which said its quarterly results gave it confidence in achieving the upper end of its earnings guidance range for the fiscal year, rose more than 5%. Pfizer and Merck each raised their fiscal year earnings guidance ranges, but Pfizer advanced 1.7% following its report while Merck slid nearly 0.5%. Ford, meanwhile, gained 1.8% after backing its fiscal year pre-tax profit view and repeating that it still expects the second half of the year to be stronger than the first half. MAJOR MOVERS: Among the notable gainers was Supervalu (SVU), which jumped 19% after the company reported better than expected first quarter results and also announced that it is exploring a separation of its Save-A-Lot business into a stand-alone, publicly traded company. Also higher was GrubHub (GRUB), which gained over 5% after reporting better than expect top and bottom line results in its second quarter and issuing 2015 guidance that analysts at Stifel said "appears conservative." Among the noteworthy losers was Immunomedics (IMMU), which tumbled 34% after the company's partner, UCB, announced that two Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus did not meet their primary clinical efficacy endpoints in either dose in both studies. Also lower following its earnings reports was Baidu (BIDU), which fell 16.5% and was downgraded by at least four research firms. INDEXES: Near midday, the Dow was up 136.13, or 0.78%, to 17,576.72, the Nasdaq was up 36.37, or 0.72%, to 5,076.14, and the S&P 500 was up 19.42, or 0.94%, to 2,087.06.
07:25 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
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07:20 EDTMRKBrookings Institute to hold a public meeting
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07:11 EDTMRKMerck reports Q2 Pharmaceutical sales $8.56B
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07:04 EDTMRKMerck narrows FY15 EPS view to $3.45-$3.55, consensus $3.45
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07:03 EDTMRKMerck reports Q2 EPS 86c, consensus 81c
Reports Q2 revenue $9.8B, consensus $9.8B.
06:49 EDTMRKMerck to acquire cCam Biotherapeutics for $95M
Merck and cCAM Biotherapeutics announced that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95M in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510M associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions.
06:32 EDTMRKMerck's grazoprevir/elbasvir application accepted by FDA
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July 27, 2015
15:03 EDTMRKNotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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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.
07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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July 23, 2015
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
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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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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