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Alnylam Begins Phase III Study on Onpattro for New Indication

Zacks Equity Research

Alnylam Pharmaceuticals, Inc. ALNY announced that it has initiated a phase III APOLLO-B study on its lead drug Onpattro (patisiran) for the treatment of transthyretin amyloidosis (ATTR amyloidosis) with cardiomyopathy. The primary endpoint of this global placebo-controlled study is to see the change from baseline in the 6-minute walk test (6MWT) at month 12.

Shares of Alnylam were up almost 1.3% following this announcement on Monday. In fact, so far this year, the stock has rallied 16.2% against the industry’s decline 1.7%.

We remind investors that the FDA and the European Commission approved Onpattro, an RNAi therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients during 2018. The drug is the first and the only FDA-approved treatment for this indication.

In June 2019, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Onpattro for the treatment of hATTR amyloidosis with polyneuropathy.

During the first half of this year, Onpattro generated sales of $64.5 million. The initial uptake of the drug has been encouraging with more than 500 patients worldwide having received Onpattro treatment since its launch as of Jun 30, 2019. Label expansion of the drug should further boost sales for the company.

Alnylam has inked several collaboration deals for the development and commercialization of its broad pipeline of RNAi therapeutic candidates. Notably, Alnylam has an alliance with Regeneron Pharmaceuticals REGN to discover, develop and commercialize new RNAi therapeutics for diseases of the eye and the central nervous system.

The company also has other candidates in its pipeline. Alnylam along with partner The Medicine Company MDCO is evaluating inclisiran in phase III ORION studies for hypercholesterolemia. Alnylam also has a pact with Sanofi’s SNY specialty care global business unit Genzyme.

Zacks Rank

Alnylam currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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