Clinical TrialsThe Phase 3 trial of tebipenem in cUTI met its primary endpoint and was stopped early for efficacy.
Financial MilestonesSPRO will receive up to $351 million in additional development, sales, and commercial milestones, along with royalties on net product sales.
Regulatory ApprovalThe FDA has indicated that positive results from the PIVOT-PO trial, along with data from prior clinical trials, would be sufficient for approval of tebipenem in cUTI.