Lantheus Holdings, Inc. (LNTH) said on Tuesday that the U.S. Food and Drug Administration has extended its review of LNTH-2501 by three months.
Shares of the company slipped marginally after hours at the time of writing.
Why The Delay?
The agency is now slated to decide on the radiopharmaceutical-focused company’s application seeking approval for the diagnostic kit by June 29. The extended deadline is expected to give the agency additional time to review and consider further manufacturing related information submitted by Lantheus, it said.
The extension, however, is not related to the efficacy or safety data of LNTH-2501, a radioactive diagnostic kit for for use with positron emission tomography (PET) for detecting somatostatin receptor positive neuroendocrine tumors in adults as well as pediatric patients, the company added.
LNTH-2501 is not available in the U.S. yet.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around LNTH stock stayed within the ‘extremely bearish’ territory while message volume fell from ‘high’ to ‘normal’ levels.
According to data from Koyfin, the 12-month average price target on the stock is at $91, representing a potential upside of about 13%. Of the 13 analysts covering the stock, 11 rate it ‘Buy’ or higher while two rate it a ‘Hold.’
Earlier this month, Lantheus announced that the FDA approved its PYLARIFY TruVu injection. The injection is indicated for imaging certain lesions in men with prostate cancer, the second most common form of cancer affecting men in the U.S. It is now expected to be commercially available in the fourth quarter of 2026.
LNTH stock has slipped 22% over the past 12 months.
Read More: LULU Shares Fall Despite Board Reshuffle As 2026 Outlook Misses Street Expectations
Get updates to this developing story directly on Stocktwits.