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January 27, 2014
04:55 EDTFCSC, FCSC, FCSC, SNY, SNY, SNY, GSK, GSK, GSK, NVS, NVS, NVS, PFE, PFE, PFE, SAFC, SAFC, SAFC, CLDX, CLDX, CLDX, CELG, CELG, CELG, WX, WX, WX, XON, XON, XON, OPXA, OPXA, OPXA, BLUE, BLUE, BLUE, BIIB, BIIB, BIIBPhacilitate to hold a forum
Cell & Gene Therapy Forum 2014 is being held in Washington, D.C. on January 27-29.
News For FCSC;BLUE;OPXA;XON;WX;CELG;CLDX;SAFC;PFE;NVS;GSK;SNY;BIIB From The Last 14 Days
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July 23, 2014
09:17 EDTBIIB, GSKOn The Fly: Pre-market Movers
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09:05 EDTBIIBBiogen says received letter from EU saying PLEGRIDY has been approved
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08:56 EDTBIIBBiogen still sees FY CapEx approximately $300M
Believes TECFIDERA is on track to become the leading MS product in the U.S. Says outside the U.S., demand for TECFIDERA has been broad; launch trajectories similar to experience in U.S. Continues to be in discussions with AIFA to resolve its dispute on Tysabri for February 2009-January 2013. Says FY guidance "meaningfully increased" due primarily to†the††growth††of††TECFIDERA†in†the†U.S.†and†the†EU.,†the†strength†of†our†other†MS†therapies and†clarity†on†the†AIFA†pricing†matter. Comments from slides that will be presented on the Q2 earnings conference call.
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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06:50 EDTBIIBBiogen raises FY14 EPS to $12.90-$13.10 from $11.35-$11.45, consensus $11.53
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06:48 EDTBIIBBiogen reports Q2 Tecfidera revenue $700M; Reports Q2 Avonex revenue $774M
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06:47 EDTBIIBBiogen reports Q2 adjusted EPS $3.49, consensus $2.83
Reports Q2 revenue $2.42B, consensus $2.16B; Non-GAAP diluted EPS was benefited by approximately 15c, following the approval from an agreement with the Italian National Medicines Agency relating to Tysabri sales in Italy.
06:41 EDTNVSArray BioPharma shares attractive at current levels, says Piper Jaffray
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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14:30 EDTBIIBBiogen technical remarks ahead of earnings
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09:55 EDTGSKLupin, private equity funds weigh bids for GSK's older drugs, Reuters reports
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07:15 EDTXONZiopharm announces expansion of oncology programs with Intrexon
Ziopharm (ZIOP) announced the expansion of synthetic immuno-oncology programs in conjunction with Intrexon (XON) to include chimeric antigen receptor T-cell, or CAR-T, therapy. Additionally the company has provided an update on its development efforts with the proprietary RheoSwitch Therapeutic System, or RTS, platform, an inducible regulator for expression of therapeutic molecules through administration of an oral activator ligand, as well as its clinical program with Ad-RTS-IL-12, a novel DNA-based therapeutic candidate for the controlled expression of IL-12. CAR-T cells represent an emerging, high value immunological therapy that can target and destroy cancer cells displaying "personalized" fingerprints, yet current approaches feature challenges associated with toxicity, off-target effects, and uneconomical manufacturing. Intrexon possesses the integrated technology platforms, molecular engineering, systems biology, and cell engineering capabilities required to overcome these challenges and fully realize the potential of CARĀ]T cell therapies. Most significantly, utilization of the RTS platform will facilitate exquisite regulation of one or more bioeffectors in CAR-T cells enabling physicians to control systemic effects of cell therapies with an appropriate dosing regimen of the oral activator ligand, and eventually bring about improved safety and efficacy of these and related therapeutic strategies. Further preclinical work is underway in this promising area of study, and ZIOPHARM and Intrexon expect to provide a progress update in the second half of 2014.
07:12 EDTCELGCelgene has upper hand in Revlimid case, says Bernstein
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July 21, 2014
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:37 EDTBIIBBiogen July weekly volatility elevated into Q2 and outlook
Biogen July weekly call option implied volatility is at 55, August is at 34, October is at 36; compared to its 26-week average of 33 according to Track Data, suggesting large near term price movement into the expected release of Q2 on July 23.
07:11 EDTNVS, GSK, SNYInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
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