US EditionClene eyeing regulatory submission for CNM-Au8 in ALS by year's end
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Clene eyeing regulatory submission for CNM-Au8 in ALS by year's end
Clene Nanomedicine is on track to seek accelerated approval of CNM-Au8 for treating amyotrophic lateral sclerosis (ALS) by the end of the year, backed by neurofilament light chain (NfL) biomarker data from its expanded access program (EAP). Those analyses, which are intended to address a recommendation from the U.S. Food and Drug Administration (FDA), are due by early fall. The company is preparing to meet with the agency to reach an agreement o…
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