Spero Therapeutics and GSK Reveal Efficacy and Safety Outcomes of PIVOT-PO Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 21 2025
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Should l Buy SPRO?
Trial Results: Spero Therapeutics and GSK announced that the phase 3 PIVOT-PO trial for tebipenem HBr, an oral treatment for complicated urinary tract infections, showed non-inferiority to intravenous imipenem-cilastatin, with overall success rates of 58.5% and 60.2%, respectively.
Safety Profile: The safety profile of tebipenem HBr was similar to other carbapenem antibiotics, with mild to moderate adverse events primarily including diarrhea and headache.
Secondary Endpoints: Clinical cure rates were 93.5% for tebipenem HBr versus 95.2% for imipenem-cilastatin, while microbiological response rates were 60.3% and 61.3%, respectively, indicating consistent results in patients with antimicrobial-resistant infections.
Regulatory Plans: GSK plans to submit the trial data to US regulatory authorities in Q4, aiming for tebipenem HBr to become the first oral carbapenem antibiotic in the US for complicated urinary tract infections, addressing antimicrobial resistance challenges.
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Analyst Views on SPRO
Wall Street analysts forecast SPRO stock price to rise
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Hold
Current: 2.410
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Current: 2.410
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About SPRO
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying and developing novel treatments for rare diseases and diseases caused by multi-drug resistant (MDR) bacterial infections with unmet need. Its product candidate SPR720 is an investigational, chemically stable phosphate ester prodrug that is converted in vivo to SPR719 for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. Its clinical stage product candidate, tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP) to help patients potentially reduce duration of in-patient therapy.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Spero Therapeutics Reports Fourth Quarter Revenue of $41.3 Million
- Company Overview: Super Therapeutics reported a revenue of USD 41.3 million for the fourth quarter.
- Financial Performance: The revenue figure indicates a significant financial performance for the company during this period.
See More
Spero Therapeutics Reports Strong Q4 Earnings
- Earnings Highlights: Spero Therapeutics reported a Q4 non-GAAP EPS of $0.53, indicating a significant improvement in profitability, which enhances the company's competitive position in the market.
- Revenue Surge: The company achieved Q4 revenue of $41.3 million, a remarkable 174.6% year-over-year increase, primarily driven by successful product launches and rising market demand, suggesting strong growth potential ahead.
- Cash Position: As of December 31, 2025, Spero had cash and cash equivalents of $40.3 million, which is projected to be sufficient to fund operations into 2028, ensuring financial stability and ongoing operational capacity.
- Market Outlook: Spero Therapeutics' Tebipenem is receiving support on its FDA pathway, with market analysts expressing optimism about its future performance, which is expected to create additional investment opportunities and market recognition for the company.
See More
SPERO THERAPEUTICS REPORTS Q4 NET INCOME OF $31.52 MILLION
Company Overview: The article discusses the financial performance of a company named Spero Therapeutics, focusing on its net income for the fourth quarter.
Financial Highlights: Spero Therapeutics reported a net income of USD 31.52 million for Q4, indicating a significant financial achievement for the company.
See More
Spero Therapeutics Reports Q4 Operating Income of $31.405 Million
- Company Overview: Super Therapeutics reported a Q4 income of $31.405 million from operations.
- Financial Performance: The reported income reflects the company's operational success during the fourth quarter.
See More
Spero Therapeutics Reports Q4 Operating Expenses of $9.892 Million
- Financial Overview: Super Therapeutics reported operating expenses of USD 9.892 million for the fourth quarter.
- Performance Insight: The financial results indicate the company's spending patterns and operational costs during the specified period.
See More
Spero Therapeutics and GSK Submit NDA for Tebipenem HBr, Triggering $25 Million Milestone Payment
- NDA Submission: Spero Therapeutics and GSK have submitted a New Drug Application (NDA) for tebipenem HBr, an antibiotic for complicated urinary tract infections, triggering a $25 million milestone payment expected in Q1 2026, significantly enhancing the company's liquidity.
- Clinical Trial Success: The NDA is supported by positive results from the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025, indicating the drug's potential in the treatment landscape and likely boosting market acceptance.
- Exclusive Licensing Agreement: Spero granted GSK exclusive commercialization rights for tebipenem HBr, except in certain Asian territories where Meiji retains rights, a strategy that aims to maximize revenue potential across global markets.
- Government Funding Support: Select studies for tebipenem HBr have been partially funded by federal funds from the Department of Health and Human Services, which not only reduces R&D costs but also enhances the company's influence in public health initiatives.
See More
Spero Therapeutics Reports Fourth Quarter Revenue of $41.3 Million
- Company Overview: Super Therapeutics reported a revenue of USD 41.3 million for the fourth quarter.
- Financial Performance: The revenue figure indicates a significant financial performance for the company during this period.
See More
Spero Therapeutics Reports Strong Q4 Earnings
- Earnings Highlights: Spero Therapeutics reported a Q4 non-GAAP EPS of $0.53, indicating a significant improvement in profitability, which enhances the company's competitive position in the market.
- Revenue Surge: The company achieved Q4 revenue of $41.3 million, a remarkable 174.6% year-over-year increase, primarily driven by successful product launches and rising market demand, suggesting strong growth potential ahead.
- Cash Position: As of December 31, 2025, Spero had cash and cash equivalents of $40.3 million, which is projected to be sufficient to fund operations into 2028, ensuring financial stability and ongoing operational capacity.
- Market Outlook: Spero Therapeutics' Tebipenem is receiving support on its FDA pathway, with market analysts expressing optimism about its future performance, which is expected to create additional investment opportunities and market recognition for the company.
See More
SPERO THERAPEUTICS REPORTS Q4 NET INCOME OF $31.52 MILLION
Company Overview: The article discusses the financial performance of a company named Spero Therapeutics, focusing on its net income for the fourth quarter.
Financial Highlights: Spero Therapeutics reported a net income of USD 31.52 million for Q4, indicating a significant financial achievement for the company.
See More
Spero Therapeutics Reports Q4 Operating Income of $31.405 Million
- Company Overview: Super Therapeutics reported a Q4 income of $31.405 million from operations.
- Financial Performance: The reported income reflects the company's operational success during the fourth quarter.
See More
Spero Therapeutics Reports Q4 Operating Expenses of $9.892 Million
- Financial Overview: Super Therapeutics reported operating expenses of USD 9.892 million for the fourth quarter.
- Performance Insight: The financial results indicate the company's spending patterns and operational costs during the specified period.
See More
Spero Therapeutics and GSK Submit NDA for Tebipenem HBr, Triggering $25 Million Milestone Payment
- NDA Submission: Spero Therapeutics and GSK have submitted a New Drug Application (NDA) for tebipenem HBr, an antibiotic for complicated urinary tract infections, triggering a $25 million milestone payment expected in Q1 2026, significantly enhancing the company's liquidity.
- Clinical Trial Success: The NDA is supported by positive results from the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025, indicating the drug's potential in the treatment landscape and likely boosting market acceptance.
- Exclusive Licensing Agreement: Spero granted GSK exclusive commercialization rights for tebipenem HBr, except in certain Asian territories where Meiji retains rights, a strategy that aims to maximize revenue potential across global markets.
- Government Funding Support: Select studies for tebipenem HBr have been partially funded by federal funds from the Department of Health and Human Services, which not only reduces R&D costs but also enhances the company's influence in public health initiatives.
See More
