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Stock Market & Financial Investment News

News Breaks
March 20, 2014
05:51 EDTAGEN, GSKGSK's MAGRIT study did not meet first or second co-primary endpoint
Agenus (AGEN) announced that GlaxoSmithKline’s (GSK) MAGRIT study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic trial in non-small cell lung cancer patients, which contains Agenus’QS-21 Stimulon adjuvant, did not meet its first or second co-primary endpoint. The study did not significantly extend the disease-free survival, or DFS, period when compared to placebo in the overall MAGE-A3 positive patients or patients who did not receive chemotherapy. GSK announced that it will continue the study until an analysis of the third co-primary endpoint is complete. The third co-primary endpoint is based on predefined criterion that was discussed with regulatory authorities. This analysis is based on gene signature and designed to prospectively identify MAGE-A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data. The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
News For AGEN;GSK From The Last 14 Days
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July 28, 2014
10:02 EDTGSKOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AcelRx (ACRX) downgraded to Hold from Buy at Canaccord... Anglo American (AAUKY) downgraded to Neutral from Buy at UBS... Aon plc (AON) downgraded to Hold from Buy at Sandler ONeill... Cabot Oil & Gas (COG) downgraded at Oppenheimer... Cisco (CSCO) downgraded to Sector Perform from Outperform at Pacific Crest... Coeur Mining (CDE) downgraded to Market Perform from Outperform at Raymond James... DSW (DSW) downgraded at Sterne Agee... DuPont Fabros (DFT) downgraded to Neutral from Buy at Citigroup... El Paso Electric (EE) downgraded to Hold from Buy at Jefferies... Enphase Energy (ENPH) downgraded to Hold from Buy at Deutsche Bank... GlaxoSmithKline (GSK) downgraded to Neutral from Buy at BofA/Merrill... Horizon Technology (HRZN) downgraded to Hold from Buy at Wunderlich... Lear (LEA) downgraded to Hold from Buy at Deutsche Bank... Life Time Fitness (LTM) downgraded at Wedbush... Monster Beverage (MNST) downgraded to Neutral from Buy at UBS... NRG Energy (NRG) downgraded to Buy from Conviction Buy at Goldman... PG&E (PCG) downgraded to Sell from Neutral at Goldman... Pfizer (PFE) downgraded at BMO Capital... Post Properties (PPS) downgraded to Neutral from Buy at Citigroup... Publicis (PUBGY) downgraded to Sell from Neutral at Citigroup... Selmer Scientific (SMLR) downgraded to Hold from Buy at Aegis... TransCanada (TRP) downgraded to Neutral from Outperform at Credit Suisse... Travelers (TRV) downgraded to Hold from Buy at Sandler O'Neill... Zurich Insurance (ZURVY) downgraded to Underperform from Market Perform at Bernstein.
08:09 EDTGSKGlaxoSmithKline downgraded to Neutral from Buy at BofA/Merrill
06:22 EDTGSKGlaxoSmithKline could eventually spin off consumer healthcare business, FT says
GlaxoSmithKline CEO Andrew Witty is considering the possibility of the company being broken up in the future, suggesting that the consumer healthcare business could be spun off if a time comes when it is more valuable as an independent company, the Financial Times reports. Witty says there are no such plans in the near term. Reference Link
July 24, 2014
13:29 EDTGSKGlaxoSmithKline facing bribery allegations in Syria, Reuters says
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12:41 EDTGSKGlaxoSmithKline reports FDA approves Flonase for OTC sales in U.S.
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11:45 EDTGSKGlaxoSmithKline downgraded to Sell from Neutral at UBS
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07:09 EDTAGENAgenus reports Q2 EPS (12c), consensus (17c)
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06:13 EDTGSK, AGENGlaxoSmithKline's malaria vaccine candidate accepted for EU regulatory review
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July 23, 2014
09:33 EDTGSKGlaxoSmithKline reports record Promacta/Revolade Q2 revenue of $92M
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09:17 EDTGSKOn The Fly: Pre-market Movers
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07:19 EDTGSKGenmab reports Q2 Arzerra net sales GBP 12.8M
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07:12 EDTGSKGlaxoSmithKline lowers 2014 core EPS outlook to 'similar' to 2013
GSK now expects 2014 core EPS to be "broadly similar" to 2013 versus previous expectations of 4%-8% growth. It added, "Given impact of recent sustained strength of Sterling on free cash flow, share repurchases over balance of 2014 likely to be immaterial."
07:09 EDTGSKGlaxoSmithKline reports Q2 core EPS down 12% to 19.1p
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07:09 EDTGSKMylan wins restraining order against Apotex for generic version of GSK's Paxil
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July 22, 2014
09:55 EDTGSKLupin, private equity funds weigh bids for GSK's older drugs, Reuters reports
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July 21, 2014
07:11 EDTGSKInternational Society of DNA Vaccines to hold a conference
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July 17, 2014
07:18 EDTGSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
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06:23 EDTGSKGlaxoSmithKline admits to bribing Chinese officials in 2001, FT reports
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July 16, 2014
07:14 EDTGSKIsis 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.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
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