Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Bio­haven is at risk of mak­ing a habit of dis­ap­point­ing its in­vestors.

Late Fri­day the biotech $BHVN re­port­ed that the FDA had re­ject­ed its ap­pli­ca­tion for rilu­zole, an old drug that they had made over in­to a sub­lin­gual for­mu­la­tion that dis­solves un­der the tongue. Ac­cord­ing to Bio­haven, the FDA had a prob­lem with the ac­tive in­gre­di­ent used in a bioe­quiv­a­lence study back in 2017, which they got from the Cana­di­an drug­mak­er Apo­tex.

Apo­tex, though, has been a dis­as­ter ground. The man­u­fac­tur­er vol­un­tar­i­ly yanked the AN­DAs on 31 drugs — in late 2017 — af­ter the FDA came across se­ri­ous man­u­fac­tur­ing de­fi­cien­cies at their plants in In­dia. A few days ago, the FDA made it of­fi­cial.

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