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Full analysis, sources & comparables →GSK has agreed to pay Spero Therapeutics $66 million upfront and up to $525 million in milestones for an exclusive license to tebipenem HBr, a Phase…
GSK on Wednesday struck a licensing deal worth up to $591 million for tebipenem HBr, an oral antibiotic developed by Spero Therapeutics that could fill a…
GSK resubmitted the tebipenem HBr NDA to the FDA on Dec 19, 2025, triggering a $25 million milestone payment to Spero Therapeutics (expected Q1 2026). GSK…
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GSK signed an exclusive global license (ex-certain Asian territories, where Meiji retains rights) with Spero Therapeutics for tebipenem HBr, a late-stage oral carbapenem antibiotic for complicated urinary tract infections (cUTI) including acute pyelonephritis. GSK paid $66M upfront plus a $9M equity investment, with up to $525M in development and commercial milestones plus tiered royalties (headline value up to ~$591M). The deal, announced Sep 21, 2022 and closed Nov 7, 2022, revived a program that nearly collapsed after the FDA refused to file Spero's original NDA in 2021 and required a confirmatory Phase 3. That risk has since largely resolved: the confirmatory PIVOT-PO Phase 3 was stopped early for efficacy in May 2025 after an IDMC interim (n=1,690), and full data at IDWeek 2025 showed tebipenem non-inferior to IV imipenem-cilastatin (58.5% vs 60.2% overall success; adjusted difference -1.3%). GSK resubmitted the NDA on Dec 19, 2025 — triggering a $25M milestone to Spero (received Q1 2026) — and the FDA set a PDUFA target action date of Jun 18, 2026. If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the US.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| GSK plc / Spero Therapeutics, Inc. (this deal) | 2022 | $600M | — |
| GSK plc / SmithKline Beecham | 2000 | $12.0B | 79 |
| GSK plc / Pfizer Inc. | 2018 | $0.0M | 77 |
| GSK plc / Novartis AG | 2014 | $16.0B | 76 |
| GSK plc / Hansoh Pharmaceutical Group Co. Ltd. | 2023 | $1.7B | 74 |
| GSK plc / Nuvalent, Inc. | 2026 | $10.6B | 70 |
| GSK plc / Sierra Oncology Inc. | 2022 | $1.9B | 70 |
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