NasdaqGM:ALVOBiotechs
Alvotech (ALVO) Is Down 9.1% After FDA Rejects AVT05 Over Facility Issues and Legal Probe
In the past few days, law firm Kirby McInerney LLP announced it is investigating Alvotech and certain executives for potential federal securities law violations after the FDA issued a complete response letter citing a failed facility inspection for its AVT05 biologics license application.
This combination of regulatory setback and investor scrutiny raises fresh questions about Alvotech’s quality controls, regulatory risk management, and disclosure practices around its biosimilar...