FDA Delays Lantheus' LNTH-2501 Approval Over Third-Party Manufacturing Issues
LNTH has more than doubled off its 52-week low of $47.25 on elevated volume (2.4× avg).
Summary
The FDA issued a Complete Response Letter (CRL) for Lantheus' LNTH-2501, a PET diagnostic imaging kit for neuroendocrine tumors, delaying its approval past the June 29 PDUFA date. The CRL cited unresolved third-party manufacturing facility conditions, not concerns about the drug's clinical data, safety, or efficacy. This is a significant setback, pushing back potential market entry and revenue for a key pipeline product. Lantheus stated it is working with its partner and the FDA to address these manufacturing issues.
At the time of this announcement, LNTH was trading at $109.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $7.1B. The 52-week trading range was $47.25 to $111.46. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.