Dec. 19 at 2:01 PM
$SPRO $2.35 bid.
Holding long position
https://stocktwits.com/G101SPM/message/639313167
BRIEF: Spero Therapeutics announces NDA resubmission of tebipenem HBr by GSK (GSK) to the FDA for the treatment of complicated urinary tract infections, including pyelonephritis .
Co announced that its development partner, GSK, filed a New Drug Application resubmission to the FDA for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections, including pyelonephritis. The NDA submission triggers a
$25 million milestone payment to Spero, expected to be received in Q1 2026.
The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number -- NCT06059846). The trial was stopped early for efficacy in May, 2025 following a planned interim analysis. Trial results were presented as a late breaker at the IDWeek conference in October 2025.
Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains development and commercialization rights.
