Lantheus Announces Three-Month Extension of PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumor...
Lantheus Holdings, Inc. (LNTH)
Last lantheus holdings, inc. earnings: 2/25 07:00 am
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Source: Yahoo! Finance
leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026. The extension and revised target Prescription Drug User Free Act (PDUFA) goal date of June 29, 2026, will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501. About LNTH-2501 (Ga 68 edotreotide) LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is currently under evaluation by the FDA as a radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric p
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News
- Is Invesco S&P MidCap 400 GARP ETF (GRPM) a Strong ETF Right Now? [Yahoo! Finance]Yahoo! Finance
- Lantheus says FDA extended review period for radioactive diagnostic kit [Seeking Alpha]Seeking Alpha
- Lantheus (LNTH) had its "outperform" rating reaffirmed by William Blair.MarketBeat
- US FDA extends review of Lantheus' diagnostic imaging kit by three months [Yahoo! Finance]Yahoo! Finance
- Lantheus (LNTH) had its "buy" rating reaffirmed by Jefferies Financial Group Inc..MarketBeat
LNTH
Earnings
- 2/26/26 - Beat
LNTH
Sec Filings
- 3/20/26 - Form ARS
- 3/20/26 - Form DEFA14A
- 3/20/26 - Form DEF
- LNTH's page on the SEC website