Investors see way past Alkermes FDA setback

18 November 2020

Despite news of a Complete Response Letter (CRL) from the US regulator, shares in Alkermes (Nasdaq: ALKS) rose 2.5% on Tuesday.

While the agency raised concerns related to a tablet coating process for ALKS 3831 (olanzapine/samidorphan), Alkermes said the issue had already been resolved, noting that “sufficient data is available to address these observations.”

The CRL did not identify or raise any concerns surrounding the clinical data in the submission and the firm has not been asked to complete any new trials to support approval.

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