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Stock Market & Financial Investment News

News Breaks
April 8, 2014
08:46 EDTGSK, TEVATeva announces first approval, launch of generic Lovaza capsules in the U.S.
Teva (TEVA) announces the approval of the generic equivalent to Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza Capsules, marketed by GlaxoSmithKline (GSK), had annual sales of approximately $1.1B in the United States, according to IMS data as of December 2013.
News For TEVA;GSK From The Last 14 Days
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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.
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 18, 2015
16:13 EDTTEVAFibrocell Science appoints Keith Goldan as CFO
Fibrocell Science announced the appointment of Keith Goldan as senior VP and Chief Financial Officer, effective immediately. Prior to joining Fibrocell, Goldan served as CFO of two publicly traded companies. Most recently he served as SVP and CFO of NuPathe, which was acquired by Teva Pharmaceutical (TEVA) in 2014.
11:36 EDTTEVAIgnyta price target raised to $17 from $14 at Leerink
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10:08 EDTTEVAEagle Pharmaceuticals price target increased to $67 from $43 at William Blair
William Blair raised its price target on Eagle Pharmaceuticals to $67 from $43 citing its belief that the company can become profitable and have significant cash flow pending the approval of EP-3102. The company added that it view last week's FDA label change for Teva's (TEVA) Treanda as a positive for EP-3102 and that its new price target assumes 2016 launch and "reasonable" penetration for EP-3102.
07:13 EDTTEVATeva volatility elevated, shares near four year high
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March 17, 2015
19:42 EDTTEVAOn The Fly: After Hours Movers
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16:03 EDTTEVAIgnyta acquires 4 oncology R&D assets from Teva for 1.5M shares of common stock
Teva (TEVA) and Ignyta (RXDX) announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7M shares at $10 per share, valuing the total offering at approximately $41.6M. Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the SEC prior to such date. Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.
10:26 EDTTEVAOptions with increasing implied volatility
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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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March 16, 2015
11:40 EDTTEVAEnzo Biochem to request rehearing of court of appeals decision
Enzo Biochem (ENZ) said, acting upon advice of counsel, that it disagrees with the March 16 split 2-to-1 decision of the Court of Appeals sitting in panel for the Federal Circuit that reverses-in-part and vacates-in-part the judgment in Enzo’s favor that Applera Corp., now Life Technologies (LIFE), infringed Enzo’s patents covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code, and remands the case to the District Court as to whether the accused product infringes. Counter to the District Court’s construction of the ‘767 patent as allowing for directly-detectable labels on nucleotides and polynucleotides, and counter to the jury’s verdict that the patent describes such labelling, the Court of Appeals, held such labelling excluded by claim 1 of that patent. Enzo notes also that the Court’s partial vacatur and reversal of the judgment does not end the case, but remands the case back to the District Court to find whether the accused product infringes. Enzo will request rehearing of that decision, both by the original panel and by the full en banc Court. Enzo believes rehearing is warranted by the panel’s failure to give appropriate weight to fact findings, including facts found by the jury, consistent with a broader construction of the patent, as required by the Supreme Court’s recent decision in Teva Pharmaceuticals (TEVA).
10:28 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA NFLX BMRN DNOW MYL TEVA PEP GE
08:44 EDTTEVAFDA warning on liquid bendamustine may help Eagle's EP-3102, says Piper Jaffray
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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