GSK and Spero Therapeutics reported Phase 3 non‑inferiority results for tebipenem HBr versus the standard of care, validating the oral antibiotic’s potential to match IV therapy and prompting plans to seek FDA approval later this year. The companies said the pivotal dataset supports an end‑of‑year filing and could expand oral outpatient options for serious infections. The win illustrates renewed investor and regulatory appetite for new oral beta‑lactam options and underscores strategies to shift inpatient therapies to the outpatient setting. Observers will monitor labeling intentions, safety data, and manufacturing scale as the partners prepare regulatory submissions.