Welcome to our dedicated page for Spero Therapeuti news (Ticker: SPRO), a resource for investors and traders seeking the latest updates and insights on Spero Therapeuti stock.
Spero Therapeutics, Inc. develops clinical-stage treatments for rare diseases and diseases with high unmet need, with news centered on anti-infective programs for multi-drug resistant bacterial infections. Updates frequently cover tebipenem HBr, an investigational oral carbapenem antibiotic for complicated urinary tract infections, including pyelonephritis, and its licensed development and commercialization relationship with GSK outside certain Asian territories.
Company announcements also report quarterly and annual operating results, business updates, clinical data presentations, FDA submission activity, portfolio-expansion efforts, cash runway commentary, and equity-compensation grants under Nasdaq rules.
Spero Therapeutics (Nasdaq: SPRO) reported first quarter 2026 results and a business update. The NDA for tebipenem HBr for cUTI, including pyelonephritis, is under FDA review with a PDUFA date of June 18, 2026.
Q1 2026 net loss was $7.2 million (vs. $13.9 million in Q1 2025), or $0.13 diluted net loss per share (vs. $0.25). Revenue was $0.3 million (vs. $5.9 million). R&D expenses fell to $2.9 million and G&A to $4.9 million. Cash and equivalents were $56.1 million, and Spero reiterates cash runway guidance into 2028.
Spero Therapeutics (Nasdaq: SPRO) will report first quarter 2026 financial results for the period ended March 31, 2026, and provide a business update on May 13, 2026 after market close. The company announced it does not intend to host a conference call.
Spero Therapeutics (NASDAQ: SPRO) reported Q4 and full-year 2025 results and a business update highlighting a resubmitted tebipenem HBr NDA and an FDA PDUFA date of June 18, 2026. Q4 2025 net income was $31.5M and full-year net income was $8.6M. Revenue totaled $41.3M in Q4 and $66.8M for 2025. R&D expense declined to $38.5M for 2025. Cash and cash equivalents were $40.3M as of December 31, 2025, with the company estimating runway into 2028.
The PIVOT-PO Phase 3 trial stopped early for efficacy and supported the NDA; safety was consistent with the carbapenem class.
Spero Therapeutics (Nasdaq: SPRO) said it will report fourth quarter and full year 2025 financial results and provide a business update on Thursday, March 26, 2026, after market close. The company noted it does not intend to host a conference call for the release.
Investors should expect a written release and related materials on that date rather than a live audio briefing.
Spero (Nasdaq: SPRO) announced that development partner GSK resubmitted a New Drug Application to the FDA for tebipenem HBr to treat complicated urinary tract infections (cUTI), including pyelonephritis, on Dec. 19, 2025.
The NDA resubmission is supported by the Phase 3 PIVOT-PO trial that was stopped early for efficacy in May 2025 and presented at IDWeek in Oct. 2025. The filing triggers a $25 million milestone payment to Spero expected in Q1 2026. GSK holds exclusive commercialization rights outside certain Asian territories where Meiji retains rights.
Spero Therapeutics (Nasdaq: SPRO) announced that on November 3, 2025 its Compensation Committee approved an inducement grant of 90,000 restricted stock units (RSUs) to one newly hired employee under the 2019 Inducement Equity Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
The RSUs vest in four equal annual installments beginning December 1, 2025, subject to the employee’s continued employment, and are governed by the 2019 Inducement Plan and an RSU agreement.
Spero Therapeutics (NASDAQ: SPRO) reported third-quarter 2025 results and a business update on Nov 13, 2025. Key items: Phase 3 PIVOT-PO results for tebipenem HBr showed non-inferiority versus IV imipenem-cilastatin (58.5% vs 60.2% overall success; adjusted difference 1.3%; 95% CI: 7.5%, 4.8%). GSK plans an FDA submission in Q4 2025 with an anticipated regulatory decision in 2H 2026. The company discontinued the SPR720 program in Q3 2025. Financials: Q3 net loss $7.4M vs $17.1M year-ago; revenue $5.4M vs $13.5M; cash and cash equivalents $48.6M, expected to fund operations into 2028.
Spero Therapeutics (Nasdaq: SPRO) said it will report its third quarter 2025 financial results and provide a business update on Thursday, November 13, 2025 after the market close. The company noted it does not intend to host a conference call.
Spero is a clinical-stage biopharmaceutical company focused on novel treatments for rare diseases and multi-drug resistant bacterial infections.
Spero Therapeutics (NASDAQ: SPRO) and GSK reported positive Phase 3 PIVOT-PO results for oral tebipenem HBr in complicated urinary tract infections (cUTI), presented Oct 20, 2025 at IDWeek. The trial was stopped early for efficacy in May 2025 and met the primary endpoint of non-inferiority versus IV imipenem-cilastatin: overall success 58.5% (261/446) vs 60.2% (291/483); adjusted difference −1.3% (95% CI −7.5%, 4.8%). Clinical cure was 93.5% vs 95.2%; microbiological response ~60% in both arms. GSK plans to include data in a US filing in Q4 2025.
Spero Therapeutics (Nasdaq: SPRO) announced presentations on oral tebipenem Hbr at IDWeek, Oct 19–22, 2025 in Atlanta.
Company and partner GSK will present late-breaking Phase 3 PIVOT-PO results for tebipenem Hbr in complicated urinary tract infection (cUTI), including pyelonephritis. An oral presentation by David K. Hong is scheduled for Oct 20, 2025, 1:45–3:00 PM ET (Session: Late Breaking Trial Results). Two posters on tebipenem antibacterial activity vs Enterobacterales will be shown on Oct 21, 2025, 12:15–1:30 PM in Poster Hall B4–B5.