Alkermes plots course to the FDA after its depression drug scores success in last-stand PhIII
Just after the start of this year, Alkermes was blasted by the news that the first two of three late-stage studies for its depression drug ALKS-5461 had failed. Analysts hit the red-alert button and the biotech’s shares $ALKS skidded down 44%, wiping out $4 billion of market cap as execs immediately pivoted and researchers scrambled to salvage the third Phase III by revamping the trial.
Today, Alkermes says that third trial scored a success. And even though it doesn’t measure up to standard FDA guidelines, which look for a positive readout from at least two of the three studies, CEO
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