SIG-119 science NOT_PUBLISHED

FDA approves Retatrutide this year?

Direction NO underpriced · Confidence HIGH · Closes 2026-12-31

Market price

21%

at signal

Our estimate

15%

calibrated

Gap

+5.8pp

market vs ours

Status

NOT_PUBLISHED

2026-12-31 close

Evidence

Retatrutide (Eli Lilly's triple GLP-1/GIP/glucagon agonist) is still in Phase 3 trials (TRIUMPH program for obesity, TRIUMPH-DM for diabetes) with primary completion dates in late 2025/2026.
Lilly has publicly guided to an FDA submission in 2026 at the earliest, with launch expected 2027 — no BLA/NDA has been filed as of early 2026.
Standard FDA review timelines are 10 months (standard) or 6 months (priority); even a priority review filed mid-2026 would push PDUFA action into 2027.
No FDA advisory committee meeting or PDUFA date for retatrutide has been announced for 2026, which is a prerequisite for an in-year approval.
Lilly's own investor communications and analyst consensus (e.g., from major sell-side) place retatrutide approval/launch firmly in 2027, not 2026.

Counter-evidence

If Lilly filed a rolling submission in late 2025 that hasn't been widely publicized and obtained priority review with breakthrough designation, an accelerated late-2026 approval is conceivable but still highly unlikely given no public filing announcement.