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. (Nasdaq: SPRO) is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections. News about Spero often centers on its lead investigational product, tebipenem pivoxil hydrobromide (tebipenem HBr), an oral carbapenem antibiotic candidate for complicated urinary tract infections (cUTI), including pyelonephritis.
Readers following SPRO news can expect updates on clinical trial milestones, such as the pivotal Phase 3 PIVOT-PO trial, which Spero and its partner GSK reported met its primary endpoint and was stopped early for efficacy. Coverage also includes presentations of clinical data at major infectious disease conferences like IDWeek, where late-breaking results and detailed efficacy and safety analyses for tebipenem HBr have been shared.
Spero’s news flow also features regulatory and partnership developments. This includes announcements that GSK plans to, and has, submitted or resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for tebipenem HBr in cUTI, including pyelonephritis, as well as disclosures about milestone payments to Spero triggered by these filings under the exclusive license agreement between the companies.
In addition, Spero regularly reports its quarterly operating results and business updates, detailing collaboration revenue, grant funding, research and development spending, and cash runway expectations. Corporate governance and capital markets news, such as inducement equity grants under Nasdaq Listing Rule 5635(c)(4), amendments to stock incentive plans, and outcomes of annual stockholder meetings, also appear in the company’s announcements.
For investors, clinicians, and observers interested in antibiotic development, MDR infections, and rare disease therapeutics, the SPRO news page provides a consolidated view of Spero’s clinical progress, regulatory interactions, financial updates, and key collaborations over time.
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.
Spero Therapeutics (Nasdaq: SPRO) reported significant Q2 2025 developments, highlighted by the early termination of the PIVOT-PO Phase 3 trial for tebipenem HBr due to meeting efficacy endpoints in complicated urinary tract infection (cUTI) treatment. The trial demonstrated non-inferiority compared to intravenous treatment, with plans for FDA submission in H2 2025 alongside partner GSK.
The company reported Q2 2025 financial results with a reduced net loss of $1.7M (vs $17.9M in Q2 2024), revenue of $14.2M (up from $10.2M), and cash position of $31.2M. With GSK milestone payments, including $23.8M received in August 2025, Spero projects runway into 2028.
However, their SPR720 program for NTM-PD was suspended in Q4 2024 after failing to meet primary endpoints in Phase 2a trials. The company also announced leadership changes with Esther Rajavelu appointed as CEO in May 2025.
Spero Therapeutics (NASDAQ:SPRO), a clinical-stage biopharmaceutical company specializing in rare diseases and multi-drug resistant bacterial infections treatments, has scheduled its second quarter 2025 financial results conference call and webcast for Tuesday, August 12, 2025, at 4:30 p.m. ET.
During the call, management will present Q2 2025 financial results and provide a business update. Investors can access the call via phone (1-844-825-9789 domestic, 1-412-317-5180 international) using conference ID 10200686, or through the live audio webcast available on Spero's investor relations website.