LNTH - Quick Take - OCTEVY CRL Further Delays Approval, Not Ideal But Not in #'s & Not Core to The Thesis

Research evidence excerpt

LNTH - Quick Take - OCTEVY CRL Further Delays Approval, Not Ideal But Not in #'s & Not Core to The Thesis

Truist Securities

Equity Research Report June 26, 2026

HEALTHCARE: Hospital Equipment/ Lantheus Holdings, Inc. (LNTH)

Supplies

LNTH - Quick Take - OCTEVY CRL Further Delays Approval, Not

Richard Newitter Ideal But Not in #'s & Not Core to The Thesis

212-319-5883

Richard.Newitter@truist.com

After the close, LNTH announced it had received a Complete Response Letter

Ravi Misra (CRL) from the FDA for LNTH-2501 (OCTEVY) the company's diagnostic agent for

212-590-0973 neuroendocrine tumors (NET) which had an extended PDUFA set for 6/29. This is an

Ravi.Misra@truist.com asset LNTH purchased through the '25 Evergreen acquisition and that had been expected

to secure approval on 3/29, but then was subsequently extended to 6/29 (LINK) due to

Felipe Lamar additional info related to manufacturing requested by the FDA. While the text of the CRL

212-326-6137 has not been made public yet, according to LNTH's press release, the FDA stated it

Felipe.Lamar@truist.com cannot approve the NDA by the PDUFA date due to "unresolved" facility inspection-related

conditions. The CRL is related to a manufacturing issue (rather than any data concerns,

Kunal Sharma or concerns around safety/efficacy) related to LNTH's third-party manufacturer (same

212-590-0907 rationale behind the original 3 month PDUFA date extension in March). The hope had been it

Kunal.Sharma2@research.truist.com would have just amounted to a 1qtr delay, but the CRL will now extend that timeline (unclear

how long). LNTH will resubmit the application once the manufacturing-related conditions at

the independent third-party facility that manufactures LNTH-2501 have been satisfactorily

resolved.