reports
Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA fo...
Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem...
Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rul...
Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) CAMBRIDGE, Mass., Nov. 28, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that on November 3, 2025, the Compensation Committee of Spero’s Board of Directors approved the grant of an aggregate of 90,000 restricted stock unit awards (RSUs) to one new employee under the Spero Therapeutics, Inc. 2019 Inducement Equity Incentive ...
Spero Therapeutics Announces Third Quarter 2025 Operating Results and ...
Spero Therapeutics Announces Third Quarter 2025 Operating Results and Provides a Business Update Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025Spero’s development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 4Q 2025 Company expects current cash and cash equivalents to fund operations into 2028 CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutic...
Spero Therapeutics to Report Third Quarter 2025 Financial Results and ...
Spero Therapeutics to Report Third Quarter 2025 Financial Results and Provide Business Update on November 13, 2025 CAMBRIDGE, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its third quarter 2025 financial results and provide a business update on Thursday, November 13, after the market close. The Company does not intend to host a conference call. About Spero Therapeu...
PIVOT-PO Phase 3 Data Show Tebipenem HBr’s Potential as the First Oral...
PIVOT-PO Phase 3 Data Show Tebipenem HBr’s Potential as the First Oral Carbapenem Antibiotic for Patients with Complicated Urinary Tract Infections (cUTIs) Data presented at IDWeek 2025 after study stopped early for efficacyPrimary endpoint met, demonstrating non-inferiority of oral tebipenem HBr compared to intravenous treatment1Data will be shared with regulatory authorities to support regulatory filings CAMBRIDGE, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) today announced efficacy and safety results of the positive pivo...
Spero Therapeutics Announces Presentations on Tebipenem Hbr at IDWeek
Spero Therapeutics Announces Presentations on Tebipenem Hbr at IDWeek Late breaking session to feature results from the successful PIVOT-PO Phase 3 trial evaluating tebipenem Hbr in complicated urinary tract infection (cUTI) CAMBRIDGE, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announces presentations on tebipenem Hbr at the upcoming annual meeting to take place Oct 19 – 22, 2025 in Atlanta, ...
Spero Therapeutics Announces Second Quarter 2025 Operating Results and...
Spero Therapeutics Announces Second Quarter 2025 Operating Results and Provides a Business Update PIVOT-PO Phase 3 trial evaluating tebipenem Hbr in complicated urinary tract infection (cUTI) patients stopped early for efficacy following review by independent data monitoring committee (IDMC)Spero, along with its development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 2H 2025 Existing cash and earned and non-contingent development milestone payments from GSK provide anticipated runway to fund the Company’s cu...
Spero Therapeutics to Report Second Quarter 2025 Financial Results and...
Spero Therapeutics to Report Second Quarter 2025 Financial Results and Provide Business Update on Tuesday, August 12, 2025 CAMBRIDGE, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO) a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that management will host a conference call and live audio webcast on Tuesday August 12th, 2025 at 4:30 p.m. ET to report financial results for second quarter 2025 and provide a business update. To access the ca...
Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipen...
Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee If approved, tebipenem HBr could be the first oral carbapenem antibiotic for US patients with complicated urinary tract infections (cUTIs) An estimated 2.9 million cases of cUTIs are treated annually in the US1 with many cases requiring hospitalization, contributing to over $6 billion per year in healthcare costs2Data from the PIVOT-PO trial to be part of a planned US Food and Drug Administration (FDA) filing in 2H 2025 that Spero’...
Spero Therapeutics Announces First Quarter 2025 Operating Results and ...
Spero Therapeutics Announces First Quarter 2025 Operating Results and Provides a Business Update Pre-specified interim analysis of the ongoing Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), on track to be completed in Q2 2025Existing cash, together with earned development milestones from GSK, provide runway to fund operating expenses and capital expenditures into Q2 2026 CAMBRIDGE, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on iden...
Spero Therapeutics to Report First Quarter 2025 Financial Results and ...
Spero Therapeutics to Report First Quarter 2025 Financial Results and Provide Business Update on Tuesday, May 13, 2025 CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its first quarter 2025 financial results and provide a business update on Tuesday, May 13, after the market close. The Company does not intend to host a conference call. About Spero TherapeuticsS...
Spero Therapeutics Appoints Esther Rajavelu as President and Chief Exe...
Spero Therapeutics Appoints Esther Rajavelu as President and Chief Executive Officer CAMBRIDGE, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Esther Rajavelu will serve as its President and Chief Executive Officer, effective May 2, 2025, and will be nominated for election as a member of the Board of Directors at Spero’s 2025 annual meeting of stockholders. Since January 2025, Ms. Ra...
Spero Therapeutics Announces Fourth Quarter and Full Year 2024 Operati...
Spero Therapeutics Announces Fourth Quarter and Full Year 2024 Operating Results and Provides a Business Update Pre-specified interim analysis of Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI) is expected to be completed in Q2 2025Company expects to complete analysis of full data set from the Phase 2 study of SPR720 for treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) and determine next steps for the programSPR206, a Phase 2 ready program for hospital and ventilator acquired bacterial pneumonia (HABP/VABP), discontinued fol...
Spero Therapeutics to Report Fourth Quarter and Full Year 2024 Financi...
Spero Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Business Update on Thursday, March 27, 2025 CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2024, and provide a business update, on March 27, 2025. Management w...
UPDATE – Spero Therapeutics to Present at TD Cowen 45th Annual Health ...
UPDATE – Spero Therapeutics to Present at TD Cowen 45th Annual Health Care Conference CAMBRIDGE, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO) (Spero), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Esther Rajavelu, Spero’s Interim President and Chief Executive Officer, management will present and will be available for one-on-one meetings at the TD Cowen 45th Annual Health Care Conference being held in Boston, March 3r...
Spero Therapeutics to Present at TD Cowen 45th Annual Health Care Conf...
Spero Therapeutics to Present at TD Cowen 45th Annual Health Care Conference CAMBRIDGE, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO) (Spero), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Esther Rajavelu, Spero’s Interim President and Chief Executive Officer, management will present and will be available for one-on-one meetings at the TD Cowen 45th Annual Health Care Conference being held in Boston, March 3rd – 5th, ...
Spero Therapeutics Provides Business Update and Announces Interim Lead...
Spero Therapeutics Provides Business Update and Announces Interim Leadership Changes Esther Rajavelu Appointed Interim President and Chief Executive Officer, Frank Thomas Appointed Chairman of the Board Interim Changes to Leadership Follow the Company’s Response to a Wells Notice from the SEC Relating to Certain Public Disclosures Made in 2022 Phase 3 PIVOT-PO Trial of Tebipenem HBr Reaches Over 60% Enrollment as of December 31, 2024; Remains on Track to Complete Enrollment in 2H 2025 Cash Balance and Cash Runway Guidance Remains into mid-2026 CAMBRIDGE, Mass., Jan. 10, 2025 (...
Spero Therapeutics Announces Third Quarter 2024 Operating Results and ...
Spero Therapeutics Announces Third Quarter 2024 Operating Results and Provides a Business Update Phase 3 PIVOT-PO trial of tebipenem HBr remains on track to complete enrollment in 2H 2025 Reiterate cash runway into mid-2026; Q3 2024 ending cash balance of $76.3M CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the third quarter e...
Spero Therapeutics to Report Third Quarter 2024 Financial Results and ...
Spero Therapeutics to Report Third Quarter 2024 Financial Results and Provide Business Update on Thursday, November 14, 2024 CAMBRIDGE, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its third quarter 2024 financial results and provide an update on its business on Thursday, November 14, after the market close. The Company does not intend to...
Spero Therapeutics Announces SPR720 Phase 2a Interim Results and Provi...
Spero Therapeutics Announces SPR720 Phase 2a Interim Results and Provides a Business Update Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for enrollment completion in 2H 2025 Cash runway extended into mid-2026 following a reduction in workforce and restructuring of operations; Unaudited Q3 2024 ending cash balance of $76.3M CAMBRIDGE, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- ...
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