SPRO Jun 17, 2026SPROFDA Updates
Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)
The FDA has approved Utebzi (tebipenem pivoxil), the first oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs). This approval follows the successful PIVOT-PO trial, demonstrating non-inferiority to intravenous treatments. Utebzi aims to provide an effective outpatient treatment option, addressing the significant healthcare burden posed by cUTIs and antibiotic resistance.
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SPRO May 13, 2026SPROFDA Updates
Spero Therapeutics Announces First Quarter 2026 Operating Results and Provides Business Update
Spero Therapeutics reported its first quarter 2026 results, highlighting the ongoing FDA review of its New Drug Application for tebipenem HBr, aimed at treating complicated urinary tract infections. The company maintains a cash runway into 2028, despite a net loss of $7.2 million for the quarter. The Phase 3 trial for tebipenem HBr showed promising results, positioning it as a potential oral alternative to IV treatments.
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SPRO May 5, 2026SPROGeneral
Spero Therapeutics to Report First Quarter 2026 Financial Results and Provide Business Update on May 13, 2026
Spero Therapeutics has announced it will report its first quarter 2026 financial results and provide a business update on May 13, 2026. The report will be released after market close, and the company has stated it will not hold a conference call. This reflects Spero's commitment to keeping stakeholders informed.
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SPRO Mar 27, 2026SPROFDA Updates
Spero Therapeutics Announces Fourth Quarter and Full Year 2025 Operating Results and Provides a Business Update
Spero Therapeutics reported its financial results for Q4 and full year 2025, highlighting significant advancements in the tebipenem HBr program for cUTI. The company completed a global Phase 3 trial and resubmitted its NDA, with an FDA decision expected in late June. Spero is focused on fulfilling its licensing agreement with GSK while exploring new clinical-stage opportunities.
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SPRO Dec 22, 2025SPROFDA Updates
Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
Spero Therapeutics announced that its partner GSK has resubmitted a New Drug Application for tebipenem HBr to the FDA for treating complicated urinary tract infections. This resubmission follows positive results from the Phase 3 PIVOT-PO trial, which was halted early due to efficacy. Spero will receive a $25 million milestone payment upon submission.
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SPRO Nov 28, 2025SPROGeneral
Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Spero Therapeutics announced the approval of 90,000 restricted stock unit awards for a new employee under its 2019 Inducement Equity Incentive Plan. This grant, approved by the Compensation Committee, is part of the company's strategy to attract talent in the clinical-stage biopharmaceutical sector. The RSUs will vest over four years, contingent on the employee's continued employment.
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SPRO Nov 13, 2025SPROGeneral
Spero Therapeutics Announces Third Quarter 2025 Operating Results and Provides a Business Update
Spero Therapeutics reported its third quarter 2025 results, highlighting the positive Phase 3 PIVOT-PO study results for tebipenem HBr, an oral antibiotic for complicated urinary tract infections. The company is collaborating with GSK to submit an FDA filing soon, with a decision anticipated in the second half of 2026. However, the SPR720 program has been discontinued following trial reviews.
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SPRO Nov 4, 2025SPROGeneral
Spero Therapeutics to Report Third Quarter 2025 Financial Results and Provide Business Update on November 13, 2025
Spero Therapeutics will report its third quarter 2025 financial results on November 13, 2025. The company, which specializes in treatments for rare diseases and multi-drug resistant infections, will provide a business update following the report. No conference call is planned for this announcement.
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SPRO Oct 21, 2025SPROPhases
PIVOT-PO Phase 3 Data Show Tebipenem HBr’s Potential as the First Oral Carbapenem Antibiotic for Patients with Complicated Urinary Tract Infections (cUTIs)
Spero Therapeutics and GSK announced positive results from the Phase 3 PIVOT-PO trial for tebipenem HBr, an oral treatment for complicated urinary tract infections (cUTIs). The trial showed that tebipenem HBr is non-inferior to intravenous imipenem-cilastatin, with a similar safety profile. This could mark the first oral carbapenem antibiotic available for cUTIs in the U.S., addressing a significant healthcare need.
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SPRO Oct 14, 2025SPROPhases
Spero Therapeutics Announces Presentations on Tebipenem Hbr at IDWeek
Spero Therapeutics announced that it will present data on tebipenem HBr at IDWeek 2025. This investigational oral carbapenem antibiotic is aimed at treating complicated urinary tract infections, including pyelonephritis. The Phase 3 PIVOT-PO trial has shown positive results, meeting its primary endpoint. GSK, Spero's partner, plans to file for FDA approval in late 2025.
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SPRO May 28, 2025SPROPhases
Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee
Spero Therapeutics and GSK announced that the Phase 3 PIVOT-PO trial for tebipenem HBr was stopped early due to meeting its primary efficacy endpoint. The trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in treating complicated urinary tract infections. The results will be included in a future NDA filing and presented at a scientific congress.
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SPRO May 5, 2025SPROGeneral
Spero Therapeutics to Report First Quarter 2025 Financial Results and Provide Business Update on Tuesday, May 13, 2025
Spero Therapeutics will announce its first quarter 2025 financial results and provide a business update on May 13, 2025. The company, which specializes in treatments for rare diseases and multi-drug resistant infections, will release the information after market close. No conference call will follow the announcement.
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SPRO Apr 28, 2025SPROGeneral
Spero Therapeutics Appoints Esther Rajavelu as President and Chief Executive Officer
Spero Therapeutics has appointed Esther Rajavelu as President and CEO, effective May 2, 2025. Rajavelu, who has been serving as Interim CEO since January 2025, will also be nominated to the Board of Directors. The company is prioritizing its PIVOT-PO Phase 3 trial for tebipenem HBr, while former CEO Sath Shukla will step down from his position and the Board.
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