Spero Therapeutics and GSK Submit NDA for Tebipenem HBr, Triggering $25 Million Milestone Payment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
0mins
Should l Buy SPRO?
Source: Globenewswire
- 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.
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Analyst Views on SPRO
Wall Street analysts forecast SPRO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SPRO is 4.00 USD with a low forecast of 4.00 USD and a high forecast of 4.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
0 Buy
2 Hold
0 Sell
Hold
Current: 2.420
Low
4.00
Averages
4.00
High
4.00
Current: 2.420
Low
4.00
Averages
4.00
High
4.00
No data
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 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 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.
See More
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.
See More
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.
See More
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.
See More
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.
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 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.
See More
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.
See More
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.
See More
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.
See More
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.
See More
