Spero Therapeutics news centers on its work as a clinical-stage biopharmaceutical company focused on immunology and inflammation. Company updates often address SP001, its third-generation, Fc-silent anti-CD40L monoclonal antibody being advanced first in IgG4-related disease.
Other important Spero news relates to Utebzi, the Spero-developed oral antibiotic licensed to GSK for most territories and to Meiji for certain Asian territories. Updates may involve FDA-related disclosures, partner-linked commercialization rights, milestone and royalty arrangements, and financing backed by portions of future Utebzi payments.
Spero also issues news on quarterly operating results, business updates, healthcare conference presentations, executive and clinical leadership appointments, and inducement equity grants under Nasdaq listing rules. These categories reflect both its drug-development pipeline and its public-company reporting obligations.
Spero Therapeutics (Nasdaq: SPRO) has appointed Debra Jeske Zack, M.D., Ph.D., as Chief Medical Officer, adding more than 25 years of experience in developing therapeutics for immune-mediated diseases. She will lead clinical development as Spero advances SP001, a Phase 2-ready third-generation anti-CD40L antibody for IgG4-related disease and other immune-mediated conditions.
According to Spero, Dr. Zack is a board-certified rheumatologist with prior leadership roles at Amgen, Exagen, Xencor and Novartis, as well as academic experience at UCLA. She will help shape clinical strategy for SP001 and future immunology pipeline opportunities.
Spero Therapeutics (Nasdaq: SPRO) announced a $105 million non-recourse, non-dilutive royalty financing with affiliates of Healthcare Royalty (HCRx), a business of KKR, backed by a portion of future Utebzi (tebipenem pivoxil) milestones and royalties from GSK.
According to Spero, proceeds will primarily fund Phase 2 development of SP001, a Phase 2-ready, Fc-silent, third-generation anti-CD40L monoclonal antibody for immune-mediated diseases, in-licensed from Innovent Biologics under an exclusive agreement signed concurrently with the financing. HCRx will receive quarterly principal and interest payments derived solely from GSK payments owed to Spero until the loan is repaid, after which Spero will retain 35% of subsequent GSK Utebzi milestone and royalty payments. Spero also updated its cash runway guidance into the second half of 2029.
Spero Therapeutics (Nasdaq: SPRO) and Innovent Biologics (01801.HK) announced an exclusive license for SP001 (IBI355), a third-generation Fc-silent anti-CD40L antibody. Spero receives exclusive rights to develop, research, manufacture, and commercialize SP001 worldwide, excluding Greater China, where Innovent retains rights.
According to Spero, Innovent will receive an upfront payment and is eligible for development, regulatory and commercial milestone payments, for a total deal value of about US$1.1 billion, plus tiered royalties on net sales in Spero’s territories. Spero expects to start a Phase 2 trial in IgG4-related disease in Q2 2027, while Innovent plans a China Phase 2 trial in Sjögren’s disease by early 2027. SP001 has been evaluated by Innovent in two Phase 1 healthy volunteer studies and a Phase 1b multiple-ascending-dose study in Sjögren’s disease patients, with data presented at the EULAR 2026 Congress.
Spero Therapeutics (Nasdaq: SPRO) and GSK (NYSE: GSK) received FDA approval for Utebzi (tebipenem pivoxil), the first and only oral carbapenem for adult complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in patients with limited or no alternative oral options.
Approval is based on the phase III PIVOT-PO trial showing non-inferiority to intravenous imipenem-cilastatin, with a 58.5% overall success rate versus 60.2% for IV therapy. Utebzi is expected to be available in the US by the end of 2026.
Compass Pathways (Nasdaq: CMPS) elected Kathleen Tregoning to its Board of Directors at the annual general meeting. She will serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee.
According to Compass Pathways, Tregoning brings extensive biopharma experience, including senior roles at Cerevel Therapeutics, Sanofi and Biogen, plus health policy work in the U.S. Congress. The company highlights progress for its investigational therapy COMP360, including two Phase 3 trials that met their primary endpoint and a rolling NDA submission and review for treatment-resistant depression.
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.