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News Breaks
May 21, 2014
08:03 EDTALNYAlnylam announces publication of pre-clinical results with ALN-AS1
Alnylam Pharmaceuticals announced the publication in the Proceedings of the National Academy of Sciences of pre-clinical results with RNAi therapeutics targeting aminolevulinic acid synthase-1 for the treatment of hepatic porphyrias, including acute intermittent porphyria. In the paper, titled “RNAi-mediated silencing of hepatic Alas1 effectively prevents and treats the induced acute attacks in acute intermittent porphyria mice,” Alnylam scientists and collaborators at the Icahn School of Medicine at Mount Sinai in New York City documented results from pre-clinical models of the human disease showing that RNAi therapeutics targeting ALAS-1 can completely block the abnormal production of toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of AIP. This new paper provides proof of concept for an RNAi therapeutic for the treatment of AIP. “Our data in a mouse model of AIP, now published in PNAS, demonstrate that RNAi therapeutics targeting ALAS-1 can achieve potent, rapid, and durable suppression of the toxic heme biosynthesis intermediates that cause the symptoms and disease pathology of AIP. As such, these findings provide key pre-clinical proof-of-concept data for our ALN-AS1 program. We believe ALN-AS1 has the potential to be a transformative therapy for patients with hepatic porphyrias including AIP, an ultra-rare genetic disease with enormous unmet medical need,” said Rachel Meyers, Ph.D., Vice President, Research and RNAi Lead Development of Alnylam. “We are currently advancing our Development Candidate for ALN-AS1, which employs our Enhanced Stabilization Chemistry-GalNAc-conjugate technology. This technology enables subcutaneous dosing with improved potency and durability, and a wide therapeutic index, and is now clinically validated based on results from our hemophilia program. We are on track to file an Investigational New Drug application for ALN-AS1 in late 2014 or early 2015, and look forward to advancing this investigational medicine to patients.”
News For ALNY From The Last 14 Days
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October 21, 2014
09:48 EDTALNYShire could target BioMarin, TheStreet's Feuerstein says
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October 15, 2014
09:57 EDTALNYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
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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