TLDR
- SPRO spikes on Phase 3 win for first oral carbapenem to treat severe UTIs
- Spero gains after oral UTI drug proves as effective as IV treatment
- Tebipenem HBr passes Phase 3, pushing SPRO stock higher pre-market
- SPRO soars as trial backs oral antibiotic rivaling IV for tough infections
- Spero hits milestone with FDA-bound UTI drug, stock climbs over 9%
Spero Therapeutics (SPRO) stock surged after the company announced strong Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTIs). SPRO closed at $2.29, up 3.62.
Spero Therapeutics, Inc., SPRO
The positive clinical outcome strengthened the company’s position as a key player in the anti-infectives market.
Strong Phase 3 Results Drive SPRO Momentum
SPRO and GSK plc reported that tebipenem HBr met its primary endpoint in the pivotal Phase 3 PIVOT-PO trial. The trial demonstrated that tebipenem HBr was non-inferior to intravenous imipenem-cilastatin in treating cUTIs, including pyelonephritis. The overall success rate reached 58.5% for tebipenem HBr compared to 60.2% for the IV comparator.
The data confirmed that oral tebipenem HBr could deliver comparable efficacy to IV therapy, offering a significant therapeutic advantage. The study’s early termination for efficacy highlighted its strong clinical performance. SPRO reported that the safety profile of tebipenem HBr matched expectations, with only mild or moderate adverse events observed.
SPRO emphasized that tebipenem HBr could change the treatment landscape for serious infections caused by multidrug-resistant bacteria. The company confirmed its plans, alongside GSK, to advance toward FDA submission by Q4 2025. These developments reinforced SPRO’s commitment to addressing antimicrobial resistance with novel, patient-friendly therapies.
Market Impact and Regulatory Path
The announcement significantly boosted SPRO stock momentum as traders responded to the company’s pivotal milestone. Tebipenem HBr’s success positions SPRO as a frontrunner in the race to develop the first oral carbapenem in the United States. Such an achievement would mark a key step in reducing hospital stays and improving access to effective treatments.
GSK plans to include these results in its upcoming regulatory filing to the U.S. Food and Drug Administration. The data package from PIVOT-PO will support tebipenem HBr’s approval pathway for cUTI patients. SPRO continues to collaborate with global partners to expand tebipenem HBr’s reach beyond U.S. markets.
The company confirmed that tebipenem HBr maintained consistent clinical and microbiological success rates in patients with antimicrobial-resistant infections. These results strengthened confidence in the therapy’s broad applicability. SPRO reaffirmed its strategic focus on developing treatments that reduce dependence on intravenous antibiotics.
Broader Implications for Anti-Infective Innovation
SPRO has long pursued innovative solutions for bacterial infections with limited treatment options. The successful Phase 3 outcome adds to its record of research excellence and aligns with public health efforts to combat antimicrobial resistance. The company’s work supports safer, more convenient alternatives for patients worldwide.
Tebipenem HBr’s development also received funding from BARDA, highlighting government support for innovative new antibiotics. This partnership highlights SPRO’s role in addressing urgent challenges related to infectious diseases. With an oral carbapenem candidate nearing approval, SPRO now stands at a transformative point in its growth.
As regulatory preparations progress, SPRO aims to strengthen its leadership in the anti-infectives market through strategic collaborations. The company expects tebipenem HBr to enhance patient outcomes and reduce healthcare burdens caused by cUTIs. SPRO continues to gain momentum, driven by breakthrough data and expanding market potential.
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