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News Breaks
January 13, 2014
08:55 EDTALNY, ALNY, SNY, SNYAlnylam to host conference call
Conference call to discuss Alnylam-Genzyme RNAi Therapeutic Alliance will be held on January 13 at 9 am. Webcast Link
News For ALNY;SNY From The Last 14 Days
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October 20, 2014
07:10 EDTSNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
October 17, 2014
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
October 16, 2014
08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
October 15, 2014
10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
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09:57 EDTALNYLeerink biotech analysts hold an analyst/industry conference call
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07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
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05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
11:23 EDTSNYBIND Therapeutics and The Conference Forum hold a conference
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09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
08:04 EDTALNYAlnylam presents new ALN-TTRsc Phase 1 trial data
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05:40 EDTALNYTekmira partner Alnylam reports positive clinical data for Patisiran study
Tekmira Pharmaceuticals (TKMR) reported that Alnylam Pharmaceuticals (ALNY) presented six-month clinical data for the ongoing Patisiran Phase II Open Label Extension, or OLE, study in patients with Familial Amyloidotic Polyneuropathy, or FAP. Patisiran is an RNAi therapeutic targeting transthyretin, or TTR, in development for the treatment of TTR-mediated amyloidosis, or ATTR, which is enabled by Tekmira's lipid nanoparticle, or LNP, technology. Alnylam presented data at the American Neurological Association's 2014 Annual Meeting. Results showed a mean 0.95 point decrease in modified Neuropathy Impairment Score at six months in 19 patients with mNIS+7 data available for the current analysis. This decrease in neuropathy progression compares favorably with the 7 to 10 point increase in mNIS+7 at six months that can be estimated from historical data sets in untreated FAP patients with similar baseline characteristics.
October 13, 2014
16:28 EDTALNYOn The Fly: Closing Wrap
Stocks on Wall Street spent most of today's quiet session see-sawing across the flat-line before dropping sharply in the final hour of trading and closing at their lows. The market opened in negative territory but soon made a move to the upside and appeared ready to break the recent market slide that has seen the S&P lose about 5% of its value. Before the averages gained significant steam, they reversed again and moved back into negative ground. The averages moved in a fairly narrow range for most of the afternoon, before accelerating to the downside with conviction in the final hour of trading. ECONOMIC EVENTS: In the U.S., no economic data of note was reported and banks and bond markets were closed in observance of the Columbus Day holiday. In China, the nation's customs administration reported a trade surplus of about $31B for September. Exports in the month increased 15.3% from a year earlier, beating expectations and making for the biggest monthly increase since February 2013. Imports rose 7%, significantly outpacing the consensus projection for a 2% decline. COMPANY NEWS: The Wall Street Journal reported that CSX (CSX) was approached by a larger rival, Canadian Pacific (CP), about a possible merger. However, Credit Suisse analyst Allison Landry wrote in a note to investors that a merger between the two would not be able to occur, due to high regulatory hurdles. Still, CSX rose $1.76, or 5.88%, to $31.70 following the Journal's report, while Canadian Pacific fell $4.40, or 2.32%, to $184.97... Shares of Fiat Chrysler Automobiles (FCAU) made their debut on the New York Stock Exchange and opened at $9 per share. The stock of the newly merged company closed trading down about 1% at $8.92... J.C. Penney (JCP) selected Marvin Ellison, who is currently executive vice president of stores at Home Depot (HD), to become its next CEO. The stock, which was also downgraded to Sell from Neutral at UBS this morning, spent much of the trading day in positive ground but moved lower late in the session and closed down 3c, or 0.42%, at $7.09. MAJOR MOVERS: Among the notable gainers was Alnylam (ALNY), which advanced $13.83, or 18.98%, to $86.68 after the company announced data from study of its treatment for patients with familial amyloidotic polyneuropathy and Piper Jaffray raised its price target on the stock to $133 from $101 citing the trial results. Among the noteworthy losers was AutoNation (AN), which fell $4.11, or 8.01%, to $47.21 after another company in the same sector, Lithia Motors (LAD), lowered its profit outlook for the third and fourth quarter and issued a lower than expected earnings forecast for fiscal 2015. Shares of Lithia, meanwhile, plunged $16.85, or 20.84%, to $64.01. Also lower were shares of GoPro (GPRO), which fell $8.38, or 9.85%, to $76.67 after a French journalist reported that the son of racing legend Michael Schumacher attributed the severity of his father's brain injury following a skiing accident on the GoPro camera mounted to his helmet. INDEXES: The Dow fell 223.03, or 1.35%, to 16,321.07, the Nasdaq dropped 62.58, or 1.46%, to 4,213.66, and the S&P 500 declined 31.39, or 1.65%, to 1,874.74.
09:44 EDTALNYAlnylam price target raised to $133 on positive Ph. 2 results at Piper Jaffray
Piper Jaffray raised Alnylam's price target to $133 from $101 following positive Phase 2 open-label extension study with patisiran in patients with familial amyloidotic polyneuropathy.
07:33 EDTALNYAmerican Neurological Association to hold annual meeting
ANA 2014: 139th Annual Meeting is being held in Baltimore on October 12-14.
07:12 EDTALNYOligonucleotide Therapeutics Society to hold annual meeting
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06:44 EDTALNYAlnylam to host conference call
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06:04 EDTALNYAlnylam's patisiran for polyneuropathy shows positive Phase 2 results
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October 8, 2014
07:18 EDTSNYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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