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Stock Market & Financial Investment News

News For A;R;SPW;SNY;WBMD;CVS;ESV;TER;BSX From The Last 14 Days
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July 28, 2015
09:28 EDTSNYRegeneron buyout talk to renew after collaboration, says Roth Capital
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07:40 EDTSNYRegeneron cancer deal could be major value driver, says RBC Capital
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05:27 EDTSNYRegeneron, Sanofi launch immuno-oncology collaboration
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July 27, 2015
08:22 EDTSNYNews reports on Regeneron Praluent label inaccurate, says RBC Capital
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08:05 EDTSNYAlnylam 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.
07:40 EDTSNYEsperion price target lowered to $120 from $130 at Citi
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05:25 EDTSNYGenzyme 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
16:00 EDTSNYRegeneron, Sanofi say the U.S. WAC price of Praluent is $40 per day
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15:27 EDTSNYEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTSNYRegeneron, Sanofi's cholesterol treatment Praluent gets FDA approval
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration approved Praluent Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses- 75 mg and 150 mg. Both doses of Praluent are available in a single 1 milliliter injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks. The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost. The U.S. WAC price of Praluent is $40 per day, $1,120 every 28 days, for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.
14:44 EDTSNYEsperion slides after FDA assigns indication for rival cholesterol drug
Shares of Esperion Therapeutics (ESPR), a drug company focused on LDL-cholesterol lowering therapies, are sharply lower in afternoon trading after the FDA granted approval for the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. WHAT'S NEW: This afternoon, the FDA announced the approval of Praluent injection, which is a PCSK9 drug marketed by Sanofi (SNY) and Regeneron (REGN). Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol, the FDA indicated. The drug, like Esperion's ETC-1002, seeks to lower patients' cholesterol. PRICE ACTION: In afternoon trading, Esperion shares are down 12% to $84.21. The stock spiked as low as $81.50 immediately after the FDA made its announcement regarding Praulent. Meanwhile, Sanofi shares are fractionally higher and Regeneron shares are halted.
14:20 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
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14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
18:21 EDTBSXOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
15:27 EDTBSXBoston Scientific weakness a buying opportunity, says BofA/Merrill
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08:00 EDTRRyder raises low end FY15 comparable EPS view to $6.45-$6.55 from $6.40-$6.55
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07:59 EDTRRyder sees Q3 comparable EPS $1.82-$1.87, consensus $1.91
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