Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis [Yahoo! Finance]
Spero Therapeutics, Inc. (SPRO)
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Source: Yahoo! Finance
identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026. The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number – NCT06059846). The trial was stopped early for efficacy in May, 2025 following a planned interim analysis. Trial results were presented as a late breaker at the IDWeek conference in October 2025. Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains develop
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SPRO
News
- Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including PyelonephritisGlobeNewswire
- Is Spero Therapeutics (NASDAQ:SPRO) In A Good Position To Deliver On Growth Plans? [Yahoo! Finance]Yahoo! Finance
- Spero Therapeutics (NASDAQ:SPRO) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=SPRO&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreetMarketBeat
- Spero Therapeutics (NASDAQ:SPRO) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=SPRO&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreetMarketBeat
- Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
SPRO
Earnings
- 11/13/25 - Beat
SPRO
Sec Filings
- 12/19/25 - Form 8-K
- 11/12/25 - Form 4
- SPRO's page on the SEC website