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pdufa.bio

LNTH-2501 (Gallium-68 edotreotide)

Updated ยทnext FDA decision on the calendar

LNTH-2501 (Gallium-68 edotreotide) is a Lantheus Holdings Inc. program in Neuroendocrine tumors (NETs) in adult and pediatric patients. The FDA issued a Complete Response Letter on Jun 26, 2026. 1 FDA decision on record below. Every date links its source.

LNTH catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Neuroendocrine tumors (NETs) in adult and pediatric patients. Sponsor: Lantheus Holdings Inc. (LNTH). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jun 26, 2026 CRLLNTHPDUFA · Jun 29, 2026LNTH

Questions

When is LNTH-2501 (Gallium-68 edotreotide)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for LNTH-2501 (Gallium-68 edotreotide); 1 FDA decision is on record below.

What happened at LNTH-2501 (Gallium-68 edotreotide)'s most recent FDA decision?

On Jun 26, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.

What is LNTH-2501 (Gallium-68 edotreotide) used for?

In our records LNTH-2501 (Gallium-68 edotreotide) is under review or in development for Neuroendocrine tumors (NETs) in adult and pediatric patients.

Who makes LNTH-2501 (Gallium-68 edotreotide)?

Lantheus Holdings Inc. (LNTH).

Has LNTH-2501 (Gallium-68 edotreotide) been approved by the FDA?

Not in our records. The FDA issued a Complete Response Letter on Jun 26, 2026.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.