Spero Therapeutics and GSK Reveal Efficacy and Safety Outcomes of PIVOT-PO Trial
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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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.
Spero Therapeutics and GSK Submit NDA for Tebipenem HBr, Triggering $25M Milestone Payment
- Milestone Payment: The NDA submission for tebipenem HBr by Spero Therapeutics and GSK triggers a $25 million milestone payment expected in Q1 2026, significantly enhancing the company's financial position and supporting future R&D efforts.
- Clinical Trial Success: This NDA submission is based on the successful Phase 3 PIVOT-PO trial results, which were stopped early for efficacy in May 2025, indicating the drug's potential in treating complicated urinary tract infections and possibly enhancing market competitiveness.
- Exclusive Licensing Agreement: Spero granted GSK exclusive commercialization rights for tebipenem HBr, except in certain Asian territories where Meiji retains rights, a strategy that will help Spero optimize resource allocation in the global market.
- Government Funding Support: Some tebipenem HBr studies have been partially funded by federal funds from the U.S. Department of Health and Human Services, which not only reduces R&D costs but may also enhance investor confidence in the company's future growth prospects.
Spero Therapeutics Grants 90,000 RSUs to New Employee Under 2019 Inducement Plan
- Employee Incentive Program: On November 3, 2025, Spero Therapeutics approved the grant of 90,000 restricted stock units (RSUs) to a new employee under its 2019 Inducement Equity Incentive Plan, aimed at attracting high-quality talent to support the company's R&D in rare diseases and multi-drug resistant bacterial infections.
- Equity Incentive Structure: The RSUs will vest in four equal annual installments starting December 1, 2025, ensuring the new employee's continued employment, which enhances long-term commitment and stability, thereby promoting the company's growth in the competitive biopharmaceutical industry.
- Compliance and Transparency: This grant complies with Nasdaq Listing Rule 5635(c)(4), indicating Spero's adherence to employee incentive regulations, which enhances investor confidence in corporate governance and improves the company's image in the capital markets.
- Strategic Human Resource Investment: By implementing this incentive measure, Spero not only attracts and retains key talent but also enhances its innovation capacity and competitive edge in the rapidly evolving biopharmaceutical market, driving future growth for the company.
Spero Therapeutics Grants 90,000 RSUs to New Employee Under 2019 Inducement Plan
- Employee Incentive Program: On November 3, 2025, Spero Therapeutics approved the grant of 90,000 restricted stock units (RSUs) to a new employee, aimed at attracting high-quality talent and enhancing the company's competitive edge.
- Equity Incentive Structure: Under the 2019 Inducement Equity Incentive Plan, the RSUs will vest in four equal annual installments starting December 1, 2025, ensuring employee retention and stability as they must remain employed to receive the incentives.
- Compliance Assurance: This grant complies with Nasdaq Listing Rule 5635(c)(4), ensuring that the company adheres to relevant regulations while attracting new employees, thereby reducing legal risks.
- Strategic Company Positioning: Spero focuses on developing innovative therapies for rare diseases and multi-drug resistant bacterial infections, and this equity incentive plan will help attract talent with relevant expertise, driving the company's long-term growth in the biopharmaceutical sector.
Most Active Stocks in Pre-Market on October 21, 2025: BYND, GSIT, SPRO, TSLL, IONZ, SQQQ, NIO, F, SMR, IONQ, GM, LAC
NASDAQ 100 Pre-Market Indicator: The NASDAQ 100 Pre-Market Indicator is up 11.37 points to 25,152.39, with a total pre-market volume of 257,461,702 shares traded.
Most Active Stocks: Beyond Meat (BYND) leads with 135,675,012 shares traded, currently priced at $2.19, while other notable stocks include GSI Technology (GSIT) and Spero Therapeutics (SPRO).
Stock Performance Highlights: NIO Inc. (NIO) is trading at $6.98, slightly above its target price, while Ford Motor Company (F) is set to report earnings on October 23, 2025, with a forecasted EPS increase of 49%.
Market Trends: IonQ, Inc. (IONQ) and General Motors Company (GM) have shown significant price movements, with GM up 6.54 points to $64.54, reflecting strong market activity.
PIVOT-PO Phase 3 Results Highlight Tebipenem HBr as a Promising First Oral Carbapenem Antibiotic for Complicated Urinary Tract Infections (cUTIs)
Study Results: The PIVOT-PO trial demonstrated that oral tebipenem HBr is non-inferior to intravenous imipenem-cilastatin for treating complicated urinary tract infections (cUTIs), achieving a 58.5% success rate compared to 60.2% for the intravenous option.
Regulatory Plans: Spero Therapeutics and GSK plan to submit data to regulatory authorities to support FDA filings for tebipenem HBr, which, if approved, would be the first oral carbapenem antibiotic available in the U.S. for cUTIs.
Health Impact: Complicated UTIs, often caused by multidrug-resistant pathogens, pose significant health risks and economic burdens, with millions of cases treated annually in the U.S. and associated healthcare costs exceeding $6 billion.
Future Implications: The introduction of an oral treatment option like tebipenem HBr could alleviate the need for intravenous antibiotics, improving patient care and addressing the challenges of antibiotic resistance in cUTIs.
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.
Spero Therapeutics and GSK Submit NDA for Tebipenem HBr, Triggering $25M Milestone Payment
- Milestone Payment: The NDA submission for tebipenem HBr by Spero Therapeutics and GSK triggers a $25 million milestone payment expected in Q1 2026, significantly enhancing the company's financial position and supporting future R&D efforts.
- Clinical Trial Success: This NDA submission is based on the successful Phase 3 PIVOT-PO trial results, which were stopped early for efficacy in May 2025, indicating the drug's potential in treating complicated urinary tract infections and possibly enhancing market competitiveness.
- Exclusive Licensing Agreement: Spero granted GSK exclusive commercialization rights for tebipenem HBr, except in certain Asian territories where Meiji retains rights, a strategy that will help Spero optimize resource allocation in the global market.
- Government Funding Support: Some tebipenem HBr studies have been partially funded by federal funds from the U.S. Department of Health and Human Services, which not only reduces R&D costs but may also enhance investor confidence in the company's future growth prospects.
Spero Therapeutics Grants 90,000 RSUs to New Employee Under 2019 Inducement Plan
- Employee Incentive Program: On November 3, 2025, Spero Therapeutics approved the grant of 90,000 restricted stock units (RSUs) to a new employee under its 2019 Inducement Equity Incentive Plan, aimed at attracting high-quality talent to support the company's R&D in rare diseases and multi-drug resistant bacterial infections.
- Equity Incentive Structure: The RSUs will vest in four equal annual installments starting December 1, 2025, ensuring the new employee's continued employment, which enhances long-term commitment and stability, thereby promoting the company's growth in the competitive biopharmaceutical industry.
- Compliance and Transparency: This grant complies with Nasdaq Listing Rule 5635(c)(4), indicating Spero's adherence to employee incentive regulations, which enhances investor confidence in corporate governance and improves the company's image in the capital markets.
- Strategic Human Resource Investment: By implementing this incentive measure, Spero not only attracts and retains key talent but also enhances its innovation capacity and competitive edge in the rapidly evolving biopharmaceutical market, driving future growth for the company.
Spero Therapeutics Grants 90,000 RSUs to New Employee Under 2019 Inducement Plan
- Employee Incentive Program: On November 3, 2025, Spero Therapeutics approved the grant of 90,000 restricted stock units (RSUs) to a new employee, aimed at attracting high-quality talent and enhancing the company's competitive edge.
- Equity Incentive Structure: Under the 2019 Inducement Equity Incentive Plan, the RSUs will vest in four equal annual installments starting December 1, 2025, ensuring employee retention and stability as they must remain employed to receive the incentives.
- Compliance Assurance: This grant complies with Nasdaq Listing Rule 5635(c)(4), ensuring that the company adheres to relevant regulations while attracting new employees, thereby reducing legal risks.
- Strategic Company Positioning: Spero focuses on developing innovative therapies for rare diseases and multi-drug resistant bacterial infections, and this equity incentive plan will help attract talent with relevant expertise, driving the company's long-term growth in the biopharmaceutical sector.
Most Active Stocks in Pre-Market on October 21, 2025: BYND, GSIT, SPRO, TSLL, IONZ, SQQQ, NIO, F, SMR, IONQ, GM, LAC
NASDAQ 100 Pre-Market Indicator: The NASDAQ 100 Pre-Market Indicator is up 11.37 points to 25,152.39, with a total pre-market volume of 257,461,702 shares traded.
Most Active Stocks: Beyond Meat (BYND) leads with 135,675,012 shares traded, currently priced at $2.19, while other notable stocks include GSI Technology (GSIT) and Spero Therapeutics (SPRO).
Stock Performance Highlights: NIO Inc. (NIO) is trading at $6.98, slightly above its target price, while Ford Motor Company (F) is set to report earnings on October 23, 2025, with a forecasted EPS increase of 49%.
Market Trends: IonQ, Inc. (IONQ) and General Motors Company (GM) have shown significant price movements, with GM up 6.54 points to $64.54, reflecting strong market activity.
PIVOT-PO Phase 3 Results Highlight Tebipenem HBr as a Promising First Oral Carbapenem Antibiotic for Complicated Urinary Tract Infections (cUTIs)
Study Results: The PIVOT-PO trial demonstrated that oral tebipenem HBr is non-inferior to intravenous imipenem-cilastatin for treating complicated urinary tract infections (cUTIs), achieving a 58.5% success rate compared to 60.2% for the intravenous option.
Regulatory Plans: Spero Therapeutics and GSK plan to submit data to regulatory authorities to support FDA filings for tebipenem HBr, which, if approved, would be the first oral carbapenem antibiotic available in the U.S. for cUTIs.
Health Impact: Complicated UTIs, often caused by multidrug-resistant pathogens, pose significant health risks and economic burdens, with millions of cases treated annually in the U.S. and associated healthcare costs exceeding $6 billion.
Future Implications: The introduction of an oral treatment option like tebipenem HBr could alleviate the need for intravenous antibiotics, improving patient care and addressing the challenges of antibiotic resistance in cUTIs.
