Al­ny­lam's new pipeline star gets on FDA fast track; ARCH-backed biotech nabs or­phan drug sta­tus

→ Just a day af­ter Black­stone and Al­ny­lam sketched out a R&D part­ner­ship as part of a sprawl­ing $2 bil­lion in­vest­ment plan, the biotech said it’s ob­tained fast track des­ig­na­tion for one of the drugs high­light­ed in the deal. The sta­tus was con­ferred to vutrisir­an in the treat­ment of polyneu­ropa­thy of hAT­TR amy­loi­do­sis — an in­di­ca­tion that Black­stone will help fund but not re­ceive roy­al­ties on. Al­ny­lam is now el­i­gi­ble to sub­mit a rolling NDA for the drug, for which Phase III re­sults are ex­pect­ed in ear­ly 2021.

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