Alnylam plunges on news of fatality in fitusiran study

7 September 2017

Shares of RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) fell 11.65% to $76.00 in pre-market trading, after it provided an update on the fitusiran and givosiran investigational RNAi therapeutic programs, with negative news on the former.

With fitusiran, an RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors, Alnylam is reporting a fatal thrombotic event in a patient with hemophilia A without inhibitors in the Phase II open-label extension (OLE) study of fitusiran. As a result, the company has suspended dosing in all ongoing fitusiran studies pending further review of the safety event and development of a risk mitigation strategy.

The news comes just 10 months after Sanofi Genzyme, a unit of French pharma major Sanofi (Euronext: SAN) elected to opt in to co-develop and co-commercialize fitusiran for the treatment of hemophilia and rare bleeding disorders (RBD) in the USA, Canada and Western Europe, paying Alnylam $100 million, under its 2014 deal worth a potential $700 million.

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