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Stock Market & Financial Investment News

News For NDAQ;AAPL;BBRY;HD;GOOG;REGN;SNY;NVO;HEK;GMCR From The Last 14 Days
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<< 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | all recent news | >>
July 27, 2015
08:30 EDTAAPLNew Apple ipad mini rumored to be 'miniature iPad Air 2,' AppleInsider says
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08:22 EDTSNY, REGNNews reports on Regeneron Praluent label inaccurate, says RBC Capital
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08:19 EDTREGNRegeneron drug price well above estimate, says Leerink
Leerink points out the $14,600 annual price for Regeneron's Praluent is well above its estimate of $5,000. The firm says the broad label and price make Praluent a $15B opportunity in the U.S. It reiterates an Outperform rating on Regeneron.
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.
07:49 EDTAAPLApple said to talk with BMW about electric car project, MacRumors reports
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07:40 EDTSNY, REGNEsperion price target lowered to $120 from $130 at Citi
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06:36 EDTAAPLNike to pay $2.4M to FuelBand customers, AppleInsider reports
Under terms agreed upon in June, Nike (NKE) will pay $2.4M to customers who purchased a FuelBand product anytime between January 19, 2012 and June 17, 2015 to settle a class action suit leveled against itself and Apple (AAPL) in 2013, AppleInsider reports. Apple was named as a defendant in the suit, but holds no responsibility or liability for attorneys' fees or costs, the report says. The plaintiffs alleged that the Fuelband was unable to accurately track calorie burn, steps, and overall activity, the report says. Reference Link
06:30 EDTAAPLSky prepares to unveil set-top box, Telegraph reports
Sky is finishing up an advanced set-top box called SkyQ, a device it hopes can help its pay-TV business compete against BT (BT), the Telegraph reports. The new hardware is set to be unveiled in the next few weeks and will offer satellite households an "Apple (AAPL) and Netflix (NFLX) style" experience, the report says, citing industry insiders. Reference Link
06:23 EDTGOOGInstagram's mobile ad revenues to reach $2.81B in 2017, eMarketer says
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06:21 EDTGOOGGoogle Ventures joins Secret Escapes' $60M funding round, TechCrunch reports
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06:05 EDTAAPLBest Buy to begin selling Apple Watch in August, WSJ reports
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06:01 EDTGOOGStocks with implied volatility below IV index mean; ASHR AMBA
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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 26, 2015
18:37 EDTBBRYPakistan orders halt to BlackBerry Enterprise Services within country, WSJ says
Pakistan has ordered mobile service providers within the country to shut down BlackBerry Enterprise Services due to security concerns, the Wall Street Journal reported Saturday. A senior government official told the Journal that remaining BlackBerry services such as messenger will be unaffected. Reference Link
July 24, 2015
16:30 EDTAAPLStocks end week lower as Apple headlines busy week of earnings
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16:00 EDTREGN, SNYRegeneron, Sanofi say the U.S. WAC price of Praluent is $40 per day
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15:41 EDTREGNRegeneron reopens, down 1.8% to $546.61 after FDA approves Praluent
15:35 EDTREGNRegeneron to resume trading at 3:40 pm ET
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15:27 EDTSNY, REGNEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTREGN, SNYRegeneron, 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.
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