LNTH - Lantheus files U.S. application for PD-L1 imaging biomarker

Lantheus ([[LNTH]] +4.0%) has filed a Drug Master File with the FDA for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology trials in 2021.NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope.Clinical trial authorization was signed off by the U.K. Medicines Healthcare Products Regulatory Agency in November 2020 for a Phase 2 study on NM-01 in non-small cell lung cancer patients.

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Lantheus files U.S. application for PD-L1 imaging biomarker