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Alnylam Pharmaceuticals Inc (ALNY.O)

ALNY.O on Nasdaq

132.01USD
21 Nov 2017
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Latest Key Developments (Source: Significant Developments)

FDA grants Alnylam breakthrough therapy designation for Patisiran
Monday, 20 Nov 2017 07:00am EST 

Nov 20 (Reuters) - Alnylam Pharmaceuticals Inc :U.S. Food and Drug Administration (FDA) grants Alnylam breakthrough therapy designation (BTD) for Patisiran for the treatment of hereditary ATTR (HATTR) amyloidosis with polyneuropathy.Alnylam Pharmaceuticals Inc - ‍Alnylam has initiated a rolling new drug application (NDA) for Patisiran and expects last submission by end of 2017​.Alnylam - ‍co, in alliance with Sanofi Genzyme, intends to file a marketing authorization application in European Union around year-end for Patisiran​.  Full Article

Arbutus’ LNP licensee Alnylam initiates rolling submission of NDA for Patisiran
Thursday, 16 Nov 2017 01:39pm EST 

Nov 16 (Reuters) - Arbutus Biopharma Corp ::Arbutus’ LNP licensee Alnylam initiates rolling submission of New Drug Application (NDA) to U.S. Food and drug Administration (fda) for Patisiran.Says Alnylam expects to submit final clinical data for Patisiran by year end ​.  Full Article

Alnylam initiates rolling submission of NDA to U.S. FDA for HATTR amyloidosis treatment
Thursday, 16 Nov 2017 07:00am EST 

Nov 16 (Reuters) - Alnylam Pharmaceuticals Inc :Alnylam initiates rolling submission of new drug application (NDA) to U.S. Food and drug administration (FDA) for patisiran for the treatment of hereditary ATTR (HATTR) amyloidosis.Alnylam Pharmaceuticals - ‍has also requested priority review of application for patisiran, if granted, could result in a 6-month review process ​.  Full Article

EMA grants Alnylam accelerated assessment of rare disease drug
Monday, 13 Nov 2017 07:30am EST 

Nov 13 (Reuters) - Alnylam Pharmaceuticals Inc :European Medicines Agency (EMA) grants Alnylam accelerated assessment of patisiran for patients with hereditary attr (hattr) amyloidosis.Alnylam Pharmaceuticals Inc - ‍company on track to submit marketing authorization application (maa) and new drug application (nda) at year-end 2017​.Alnylam Pharmaceuticals Inc - ‍alnylam intends to file a marketing authorization application (maa) in european union (eu) at year-end 2017​.Alnylam Pharmaceuticals Inc - ‍alnylam plans to file a new drug application for patisiran in united states by end of 2017​.Alnylam Pharmaceuticals Inc - ‍pending regulatory approvals, alnylam will commercialize patisiran in u.s., canada and western europe​.Alnylam Pharmaceuticals Inc - ‍pending regulatory approvals sanofi genzyme commercializing product in rest of world​.  Full Article

Alnylam announces proposed public offering to raise about $675 mln
Monday, 13 Nov 2017 07:00am EST 

Nov 13 (Reuters) - Alnylam Pharmaceuticals Inc -:Alnylam Pharmaceuticals announces proposed public offering of $675,000,000 of common stock.Alnylam Pharmaceuticals Inc - ‍commencement of underwritten public offering of shares of common stock to raise proceeds of about $675 million.  Full Article

Alnylam announces successful outcome following FDA type A meeting
Thursday, 9 Nov 2017 04:00pm EST 

Nov 9 (Reuters) - Alnylam Pharmaceuticals Inc :Alnylam announces successful outcome following fda type a meeting to discuss fitusiran program in hemophilia.Alignment reached with fda on amended safety measures and risk mitigation strategy to enable resumption of fitusiran clinical program​.Reinitiation of dosing targeted around year-end​.With completion of type a meeting, fda will now consider removal of clinical hold upon final review of amended protocols, other trial materials​.  Full Article

Alnylam Pharmaceuticals Q3 non-gaap loss per share $1.06
Tuesday, 7 Nov 2017 04:00pm EST 

Nov 7 (Reuters) - Alnylam Pharmaceuticals Inc ::Alnylam Pharmaceuticals reports third quarter 2017 financial results and highlights recent period activity.Q3 non-gaap loss per share $1.06.Q3 earnings per share view $-1.26 -- Thomson Reuters I/B/E/S.Alnylam Pharmaceuticals-qtrly ‍cash,cash equivalents,fixed income marketable securities,restricted investments $1.15 billion versus $1.09 billion at Dec 31,2016​.Alnylam Pharmaceuticals Inc - ‍remains on track to end 2017 with greater than $1.0 billion in cash, cash equivalents and fixed income marketable securities​.Alnylam Pharmaceuticals Inc says qtrly net loss per common share - basic and diluted $1.34‍​.Alnylam Pharmaceuticals Inc - qtrly net revenues from collaborators $17.1 million versus $13.7 million ‍​.  Full Article

Alnylam initiates ENVISION Phase 3 clinical study with givosiran
Tuesday, 7 Nov 2017 07:00am EST 

Nov 7 (Reuters) - Alnylam Pharmaceuticals Inc :Alnylam initiates ENVISION Phase 3 clinical study with givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias (AHPs).Alnylam Pharmaceuticals Inc - ‍intends to file a new drug application (NDA) for givosiran at or around year-end 2018​.Alnylam Pharmaceuticals Inc - ‍also reached alignment on ENVISION Phase 3 study design with European Medicines Agency​.Alnylam Pharmaceuticals - reiterating previous guidance that it expects to report interim analysis data in mid-2018 from ENVISION Phase 3​ study.  Full Article

The Medicines Co and Alnylam Pharmaceuticals to start phase III clinical trials of inclisiran
Monday, 6 Nov 2017 07:00am EST 

Nov 6 (Reuters) - Medicines Co :The Medicines Company and Alnylam Pharmaceuticals announce initiation of phase III clinical trials of inclisiran.Medicines Co - ‍continues to expect that all of these trials will commence before end of 2017​.  Full Article

Alnylam and Vir form strategic alliance to advance RNAi therapeutics for infectious diseases
Wednesday, 18 Oct 2017 07:01am EDT 

Oct 18 (Reuters) - Alnylam Pharmaceuticals Inc :Alnylam and Vir form strategic alliance to advance RNAi therapeutics for infectious diseases.Alnylam Pharmaceuticals Inc - ‍Agreement includes investigational RNAi therapeutic program for hepatitis B virus infection​.Alnylam Pharmaceuticals Inc - ‍Under terms of agreement, alnylam will receive an upfront payment, comprised of cash and shares of Vir common stock​.Alnylam - ‍Agreement includes discovery collaboration on additional development candidates for treatment of infectious diseases​.Alnylam Pharmaceuticals - Also eligible to receive more than $1 billion in potential milestone payments related to successful advancement of ALN-HBV02​.Alnylam Pharmaceuticals Inc - ‍As part of this agreement, companies will advance Alnylam's HBV program​.Alnylam Pharmaceuticals Inc - Plans to discontinue further development of ALN-HBV for treatment of chronic hbv infection​.Alnylam Pharmaceuticals Inc - ‍ Alnylam will lead ALN-HBV02 to ind filing, with vir then progressing ALN-HBV02 through human proof of concept​.Alnylam- ‍As part of agreement, cos will advance initiate research collaboration for development, advancement of up to 4 rnai therapeutic programs​.  Full Article

BRIEF-FDA grants Alnylam breakthrough therapy designation for Patisiran

* U.S. Food and Drug Administration (FDA) grants Alnylam breakthrough therapy designation (BTD) for Patisiran for the treatment of hereditary ATTR (HATTR) amyloidosis with polyneuropathy