Spero Therapeutics

SPRO

Market cap $164M

New Drug Application (NDA) for tebipenem HBr for complicated urinary tract infections (cUTI), including pyelonephritis, is under review at the FDA, with PDUFA date of June 18, 2026 Spero maintains its cash runway guidance into 2028 CAMBRIDGE, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

CAMBRIDGE, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced that it will report its financial results for the first quarter ended March 31, 2026, and provide a business update on Wednesday, May 13, 2026, after market close.

CAMBRIDGE, Mass., March 26, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

CAMBRIDGE, Mass., March 18, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2025, and provide a business update on Thursday, March 26, 2026, after market close. The Company does not intend to host a conference call.

Spero Therapeutics' lead asset is an oral carbapenem tebipenem for cUTI. This asset achieved Phase 3 noninferiority. In fact, this data supports GSK's NDA resubmission strategy. The prior FDA setback from ADAPT-PO was addressed through PIVOT-PO. The new PIVOT-PO trial was actually stopped early after strong interim efficacy results. So, I believe their data is quite favorable this time.

CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, 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 antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.

CAMBRIDGE, Mass., Nov. 28, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics , 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 Plan, as amended (2019 Inducement Plan). The RSUs are being granted as an inducement material to Spero's new employee in accordance with Nasdaq Listing Rule 5635(c)(4).

Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025 Spero'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) -- Spero Therapeutics, 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 financial results for the third quarter ended September 30, 2025, and provided a business update.

CAMBRIDGE, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics , 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.

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 pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis (NCT06059846). These results were presented on October 20, 2025, in a late-breaking oral abstract session at IDWeek 2025 in Atlanta, Georgia.