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News Breaks
April 15, 2014
07:35 EDTALNY, NVSAlnylam outlook not affected by Novartis decision, says JMP Securities
After Novartis (NVS) discontinued its RNAi drug discovery program, JMP Securities does not think the decision should affect the potential of Alnylam's (ALNY) pipeline. The firm believes that Novartis' inability to figure out RNAi technology - and not problems with RNAi as a whole - led to Nvoartis' decision. The firm reiterates a $110 price target and Outperform rating on Alnylam.
News For ALNY;NVS From The Last 14 Days
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October 23, 2014
11:57 EDTNVSNovartis management to meet with Jefferies
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05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
09:48 EDTALNYShire could target BioMarin, TheStreet's Feuerstein says
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07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
09:57 EDTALNYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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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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