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Stock Market & Financial Investment News

News Breaks
July 16, 2014
07:14 EDTGSK, ISISIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
News For ISIS;GSK From The Last 14 Days
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March 29, 2015
15:46 EDTGSKGSK reaches agreement with UK on meningitis B vaccine
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March 26, 2015
11:13 EDTGSKBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:10 EDTISISAnalyst calls sharp pullback in biotech stocks 'misguided'
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06:45 EDTISISBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 24, 2015
07:45 EDTGSKFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
09:45 EDTGSKUBS to hold a field trip
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07:36 EDTGSKPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
07:04 EDTISISIsis Pharmaceuticals says ISIS-ANGPTL3Rx 'well tolerated' in Phase 1 study
Isis Pharmaceuticals announced positive results from a Phase 1 study with ISIS-ANGPTL3Rx. In this study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 of up to 93% with a mean reduction of up to 84% from baseline. In addition, statistically significant reductions from baseline in lipid parameters were observed, including up to 63% with a mean reduction of up to 49% in triglycerides and up to 46% with a mean reduction of up to 28% in total cholesterol. ANGPTL3 is a protein that acts as a key regulator of these blood lipids. These data were presented at the 83rd European Atherosclerosis Society in Glasgow, United Kingdom. The Phase 1 study of ISIS-ANGPTL3Rx was a blinded, placebo-controlled, dose-escalation study in healthy volunteers. The study was designed to assess the safety, tolerability and pharmacokinetics of ISIS-ANGPTL3Rx. ISIS-ANGPTL3Rx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg per week up to 400 mg per week for the multiple dose. In this study, ISIS-ANGPTL3Rx was generally well tolerated.
March 22, 2015
15:17 EDTGSKGSK looks to conclude negotiations with U.K. on vaccine cost, Bloomberg says
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March 20, 2015
12:41 EDTGSKOn The Fly: Midday Wrap
Stocks began the day sharply higher and have continued to tack on gains throughout the morning. The market’s move put the Nasdaq back above 5,000 and the S&P above 2,100. The market is undergoing quadruple witching, which occurs 4 times per year and typically is accompanied by high volume and volatility. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. The Baker Hughes U.S. rig count, which has been closely watched in recent months amid the protracted slide in oil prices, is expected at 1:00 pm EDT. The count of U.S. rigs stood at 1125 at the end of last week. In Europe, reports indicate German Chancellor Angela Merkel said Greece has agreed to send a list of overhauled reforms to European officials within days. COMPANY NEWS: Shares of Nike (NKE) advanced 4% following its Q3 earnings beat. Credit Suisse raised Nike's price target to $106 following the report, saying Nike's underlying futures growth remains in double-digits and preliminary FY16 guidance suggests management has been effective in managing currency headwinds... The shares of Biogen (BIIB) rallied 8% after the company reported results for an early stage study of its Alzheimer's drug, BIIB-037. The company announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. MAJOR MOVERS: Among the notable gainers was Prothena (PRTA), which surged 30% after announcing results from a Phase 1 single ascending dose study of its potential treatment of Parkinson's disease. Also higher was Darden Restaurants (DRI), which gained 4% after the owner of the Olive Garden and Long Horn restaurant chains reported earnings that beat expectations. Among the noteworthy losers was China's Youku Tudou (YOKU), which dropped 9% and was downgraded to Sell at Deutsche Bank after the company reported mixed Q4 results. Also lower was Theravance (THRX), which fell 7% after the company and partner GlaxoSmithKline (GSK) announced that an FDA advisory committee voted that the efficacy data for their Breo Ellipta inhaler provides substantial evidence of a clinically meaningful benefit in adults, however it voted against approval for the proposed indication in 12-17 year olds. INDEXES: Near midday, the Dow was up 189.04, or 1.05%, to 18,148.07, the Nasdaq was up 40.24, or 0.81%, to 5,032.62, and the S&P 500 was up 19.54, or 0.94%, to 2,108.81.
11:45 EDTISISIsis Pharmaceuticals management to meet with Needham
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09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO® ELLIPTA®), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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March 17, 2015
10:00 EDTISISOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Aimco (AIV) initiated with an Outperform at RW Baird... Alnylam (ALNY) initiated with a Buy at Janney Capital... American Campus (ACC) initiated with a Neutral at RW Baird... AvalonBay (AVB) initiated with a Neutral at RW Baird... BE Aerospace (BEAV) initiated with a Buy at CRT Capital... BlackRock (BLK) initiated with a Buy at Argus... Camden Property (CPT) initiated with an Outperform at RW Baird... CarMax (KMX) initiated with a Buy at Evercore ISI... Central Pacific (CPF) initiated with a Neutral at Macquarie... Cognex (CGNX) initiated with a Buy at Northcoast... Education Realty (EDR) initiated with a Neutral at RW Baird... EnerSys (ENS) initiated with an Overweight at Stephens... Equity Lifestyle (ELS) initiated with an Outperform at RW Baird... Equity Residential (EQR) initiated with a Neutral at RW Baird... Essex Property Trust (ESS) initiated with a Neutral at RW Baird... Facebook (FB) initiated with a Buy at Brean Capital... Intercept (ICPT) initiated with a Hold at MLV & Co.... Isis Pharmaceuticals (ISIS) initiated with a Neutral at Janney Capital... LinkedIn (LNKD) initiated with a Sell at Brean Capital... Mid-America Apartment (MAA) initiated with an Outperform at RW Baird... NetSuite (N) initiated with a Hold at Brean Capital... Paycom (PAYC) initiated with a Buy at Brean Capital... Platform Specialty Products (PAH) initiated with a Buy at UBS... Post Properties (PPS) initiated with a Neutral at RW Baird... Salesforce.com (CRM) initiated with a Hold at Brean Capital... ServiceNow (NOW) initiated with a Buy at Brean Capital... Snap-On (SNA) initiated with a Buy at Northcoast... Sun Communities (SUI) initiated with a Neutral at RW Baird... Twitter (TWTR) initiated with a Buy at Brean Capital... UDR, Inc. (UDR) initiated with an Outperform at RW Baird... Workday (WDAY) initiated with a Hold at Brean Capital... Xplore Technologies (XPLR) initiated with a Buy at Roth Capital... Yahoo (YHOO) initiated with a Hold at Argus.
08:20 EDTISISIsis Pharmaceuticals initiated with a Neutral at Janney Capital
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07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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