Spero Therapeutics, Inc. SPRO
Spero Therapeutics, Inc. (Nasdaq: SPRO) is an immunology/inflammation drug developer. Its lead program, SP001, is in Phase 1 for IgG4-related disease. Its next catalyst on record is SP001: Advance into Phase 2 trial in IgG4-RD patients (subject to FDA IND clearance) (Q2 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: SP001 — Advance into Phase 2 trial in IgG4-RD patients (subject to FDA IND clearance) (Q2 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| SP001 (anti-CD40L Fc-silent IgG1 mAb, in-licensed from Innovent) | IgG4-related disease (also Sjogren's disease data from Innovent Phase 1b) | antibody | Phase 1 |
Recent results and decisions
- Jun 17, 2026approval FDA approved Utebzi, the first oral carbapenem, for adults with cUTI including pyelonephritis with limited or no alternative oral options; based on PIVOT-PO non-inferiority (58.5% vs 60.2%).
the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis
Filing - Mar 26, 2026accepted GSK resubmitted the tebipenem HBr NDA in December 2025; FDA set a PDUFA date of June 18, 2026.
In February 2026, GSK announced that the FDA set the Prescription Drug User Fee Act (“PDUFA”) date as June 18, 2026.
Filing - Nov 13, 2025met PIVOT-PO met primary endpoint (non-inferiority): overall response 58.5% oral tebipenem HBr vs 60.2% IV imipenem-cilastatin, adjusted difference -1.3% (95% CI -7.5, 4.8); presented at IDWeek.
Tebipenem HBr (oral, 600 mg) achieved a 58.5% overall success rate (261/446 participants) compared to 60.2% overall success rate (291/483 participants) for imipenem-cilastatin (intravenous, 500 mg)
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.