Alnylam shares dip on a decision to scrap accelerated pitch on givosiran; Loxo gets a 'breakthrough' at the FDA
→ Alnylam $ALNY has decided to put a hold on its plans to shoot for an accelerated approval of givosiran and instead start a rolling submission in search of a full approval. Investors didn’t care for what looked like a slowdown, driving shares down by 1.8%. But at least one analyst was holding fire this morning. Stifel’s Paul Matteis noted: “This is not a surprise to us: this plan is, in our opinion, a byproduct of faster than expected enrollment of the phase III ENVISION trial, and we’d be buying the stock on any weakness that ensues.” This drug has been lined up as Alnylam’s second RNAi drug intended for the market. The drug is designed to treat acute hepatic porphyria.
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