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News Breaks
May 13, 2014
08:01 EDTALNYAlnylam announces results from ongoing phase 1 trial of ALN-AT3
Alnylam Pharmaceuticals announced top-line results from its ongoing Phase 1 trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin in development for the treatment of hemophilia and rare bleeding disorders. These top-line results are being presented at the World Federation of Hemophilia 2014 World Congress being held May 11 – 15, 2014 in Melbourne, Australia. In Part A of the Phase 1 study, human volunteer subjects received a single subcutaneous dose of ALN-AT3 and, per protocol, the maximum allowable level of AT knockdown was set at 40%. Initial results show that a single, low subcutaneous dose of ALN-AT3 at 0.03 mg/kg resulted in an up to 28-32% knockdown of AT at nadir that was statistically significant relative to placebo. This led to a statistically significant increase in peak thrombin generation, that was temporally associated and consistent with the degree of AT knockdown. ALN-AT3 was found to be well tolerated with no significant adverse events reported. With these data, the company has transitioned to the Multiple Ascending Dose Part B of the study in moderate-to-severe hemophilia subjects. Consistent with previous guidance, the company plans to present initial clinical results from the Phase 1 study, including results in hemophilia subjects, by the end of the year. These human study results are the first to be reported for Alnylam’s Enhanced Stabilization Chemistry-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index. Further, these initial clinical results demonstrate a greater than 50-fold potency improvement with ESC-GalNAc conjugates relative to standard template chemistry conjugates.
News For ALNY From The Last 14 Days
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August 31, 2015
16:23 EDTALNYOn The Fly: Top stock stories for Monday
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12:20 EDTALNYOn The Fly: Top stock stories at midday
Stocks on Wall Street were lower at midday, putting the averages on track to close out a down month with a down day. The weakness is being attributed to comments from several Fed officials on the likelihood of interest rates rising sometime this year. Also impacting the negative tone may be the media reports regarding China pulling back on its recent asset purchases to shore up its stock market. ECONOMIC EVENTS: In the U.S., the Chicago PMI dipped to 54.4 in August from 54.7 in July, versus expectations for it to have edged up to 54.5. The Dallas Fed manufacturing survey general activity index fell to -15.8, versus expectations for a reading of -4.0. In Asia, Chinese stocks fell once again, with the Shanghai composite index closing down 0.82% to finish the month of August with a 12% decline. Japan's Nikkei index finished the month with an even worse daily decline, falling about 1.3%, giving the Nikkei an 8% drop during August. In Europe, a flash estimate from Eurostat showed inflation in the euro area remained unchanged at 0.2% in August. COMPANY NEWS: Shares of Phillips 66 (PSX) advanced 3% after Warren Buffett's Berkshire Hathaway (BRK.A) disclosed late Friday a $4.5B stake in the oil and gas refining and marketing company. Berkshire owns of the oil refiner. Berkshire increased its stake in Phillips 66 to nearly 58M shares between August 26 and August 28, according to filings with the SEC... Intel (INTC) and Goldman Sachs (GS) were the top gainers on the Dow and among the only names in the green among the members of the bluechip index, as both stocks benefited from analyst upgrades. Research firm Northland Capital upgraded Intel to Outperform, saying that the PC market has bottomed and that the chipmaking giant should benefit from its pending acquisition of Altera (ALTR), while Evercore ISI upgraded Goldman Sachs to Buy, saying the recent pickup in volatility has led to higher trading volumes, which should give a boost to the typically slowest summer month of the year. MAJOR MOVERS: Among the notable gainers was Vital Therapies (VTL), which gained 14% after the company announced that additional data from its VTI-208 clinical trial were presented this weekend at an international symposium on dialysis in liver disease. Also higher were shares of The Medicines Company (MDCO), which rose 18% after several analyst said that a Phase I trial of the company's ALN-PCSsc cholesterol treatment yielded better than expected results. Shares of The Medicines Company's partner on the drug, Alnylam Pharmaceuticals (ALNY), slipped 4% following the data announcement. Also lower were shares of ConforMIS (CFMS), which fell 18% after the company initiated a voluntary recall of specific serial numbers of patient-specific instrumentation for its knee replacement product systems and lowered its fiscal year revenue guidance. INDEXES: Near midday, the Dow was down 61.37, or 0.37%, to 16,581.64, the Nasdaq was down 16.59, or 0.34%, to 4,811.74, and the S&P 500 was down 8.73, or 0.44%, to 1,980.14.
07:45 EDTALNYRegeneron should be bought on any pullbacks, says RBC Capital
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06:35 EDTALNYAlnylam price target raised to $184 from $180 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Alnylam Pharmaceuticals (ALNY) to $184 saying the company over the weekend reported positive Phase I data on ALN-PCS showing LDL-cholesterol lowering comparable to Amgen (AMGN) and Sanofi/Regeneron's (REGN) anti-PCSK9 antibodies, but with only quarterly or potentially every 6-month injections. Tenthoff recommends using the recent pullback in shares of Alnylam as a buying opportunity and keeps an Overweight rating on the name.
August 30, 2015
15:50 EDTALNYAlnylam, The Medicines Co. say ALN-PCSsc reduces LDL cholesterol as much as 83%
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August 28, 2015
12:59 EDTALNYFly Watch: Medicines Co., Alnylam rise ahead of cholesterol study presentation
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August 26, 2015
07:09 EDTALNYVertex, Novavax among select biotechs to buy on weakness, says Piper Jaffray
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August 24, 2015
11:43 EDTALNYThe Medicines Co. and Alnylam Pharmaceuticals hold a joint conference call
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August 20, 2015
07:31 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
Final Roundtable in a series of online "RNAi Roundtables" entitled, "Patisiran & Revusiran for Treatment of Transthyretin (TTR)-Mediated Amyloidosis", consisting of presentations by Alnylam scientists, clinical collaborators and patient advocates review recent progress in many of the company's development-stage pipeline programs will be held on August 20 at 9 am. Webcast Link
August 17, 2015
06:22 EDTALNYPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).

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