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Alnylam Files Application for Hypertension Candidate in UK

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has submitted a clinical trial authorization (CTA) application to The Medicines and Healthcare products Regulatory Agency (MHRA) ) in the United Kingdom to initiate a phase I study of ALN-AGT. ALN-AGT is an investigational RNA interference (RNAi) therapeutic targeting angiotensinogen for the treatment of uncontrolled hypertension. Upon receiving the MHRA approval, the company plans to initiate the phase I study in mid-2019.

Shares of the company have slumped 38.2% compared with the industry’s decline of 18.9%.

Alnylam also has several other RNAi candidates in its pipeline. However, the company’s first FDA-approved RNAi therapeutic is Onpattro (patisiran) lipid complex injection, available in the United States for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. In the EU, Onpattro is approved for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. 

Alnylam has several candidates in development stages. In October 2018, Alnylam submitted a CTA application for ALN-AAT02, an investigational RNAi therapeutic, for the treatment of alpha-1 antitrypsin deficiency-associated liver disease (alpha-1 liver disease). Alnylam announced that it has initiated a phase I study of ALN-AAT02, with initial results expected in 2019.

The company advanced givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyria (AHP). It initiated rolling submission of a new drug application (NDA) with plans to pursue full approval based on complete results expected in March 2019 from the ENVISION phase III study. Assuming that the results will be positive, the company expects to submit full clinical sections to the FDA in mid-2019.

The company is also evaluating inclisiran along with The Medicines Company (MDCO - Free Report) in phase III ORION studies for hypercholesterolemia. The company expects to file an NDA in the United States at or around 2019-end, assuming positive phase III results.

 

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Celgene Corporation (CELG - Free Report) and BioDelivery Sciences International, Inc. (BDSI - Free Report) , each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings per share estimates have increased from $10.34 to $10.73 for 2019 and from $12.28 to $12.76 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.

BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 20 cents for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 8.57%.

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