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SPRO PDUFA Date: Tebipenem HBr (SPR994)

FDA decision (PDUFA) target 2026-06-18 · Spero Therapeutics Inc. · Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP)

SPRO run-up into the PDUFA (last ~120 days)

$2.98$2.11
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-18
Drug / candidateTebipenem HBr (SPR994)
IndicationComplicated urinary tract infection (cUTI), including acute pyelonephritis (AP)
CompanySpero Therapeutics Inc.
Market-cap tierMicro
Cohort decision-day move (history)±7% median
ClinicalTrials.govNCT06059846 · completed

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FAQ

When is the SPRO PDUFA date?
The FDA PDUFA target date for SPRO (Spero Therapeutics Inc.) is 2026-06-18 for Tebipenem HBr (SPR994). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is SPRO's drug Tebipenem HBr (SPR994)?
Tebipenem HBr (SPR994) is Spero Therapeutics Inc.'s candidate under FDA review for Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).
What typically happens to a micro-cap stock into a PDUFA date?
Historically, micro-cap names had a median decision-day move around ±7% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.