According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- ELEVIDYS, a prescription gene therapy intended for certain patients being treated for Duchenne muscular dystrophy, posed significant safety risks to patients;
- ELEVIDYS trial regimes and protocols failed to detect severe side effects;
- the severity of adverse events from ELEVIDYS treatment would cause Sarepta to halt recruitment and dosing in ELEVIDYS trials, attract regulatory scrutiny, and create greater risk around the therapy’s present and expanded approvals; and
- as a result of the foregoing, defendants materially misled with, and/or lacked a reasonable basis for, their positive statements.
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