Sanofi/Alnylam Say FDA Lifts Clinical Hold On Fitusiran

Sanofi (PA:SASY) (NYSE:SNY) and partner Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate fitusiran.

In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNA interference (RNAi) therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).

Alnylam and Sanofi are taking additional risk mitigation measures for fitusiran studies as there have been concerns about risks around safety in hemophilia disease. Protocol amendments and other updated clinical materials for these studies have been approved by the FDA. Dosing in fitusiran studies including OLE and phase III ATLAS studies is expected to resume around end of the year.

A look at Alnylam’s share price movement shows that the stock has massively outperformed the industry year to date. The stock has surged 235.4% compared with the industry’s growth of 3.4%.

Meanwhile, Sanofi’s shares have gained 6.7% so far this year, comparing unfavorably with the industry’s gain of 17.1%. The company carries a Zacks Rank #4 (Sell).

Please note that Alnylam and Sanofi have an agreement to co-develop and co-commercialize fitusiran in the United States, Canada and Western Europe while Sanofi will exclusively market the candidate, on approval, in rest of the world.

Some better-ranked stocks in the biotech/genetics sector include Emergent BioSolutions Inc. (NYSE:EBS) and XOMA Corporation (NASDAQ:XOMA) , both with a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent BioSolutions’ earnings estimates have moved up by 11.5% for 2018 over the last 30 days. Share price of the company has risen 42.5% year to date.

While XOMA shares have skyrocketed 655.5% year to date, its 2018 loss estimates have narrowed almost 20% over the past 60 days.

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