1. Spero's partner GSK filed an NDA resubmission for tebipenem HBr. 2. Approval could trigger a $25 million milestone payment in Q1 2026. 3. The NDA is backed by successful Phase 3 PIVOT-PO trial results. 4. Spero retains rights in certain Asian territories while GSK commercializes the drug. 5. There are regulatory risks and potential delays in FDA approval.
FAQ
Why Bullish?
The NDA resubmission could unlock substantial capital. Historical patterns show similar FDA approvals positively impacting stock prices.
How important is it?
The milestone payment indicates tangible financial impact, enhancing investor confidence.
Why Short Term?
The $25 million milestone payment is imminent. Market reactions typically engage within the next quarter after such announcements.
Spero Therapeutics Resubmits NDA for Tebipenem HBr: Key Developments for Investors
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- In a significant development for Spero Therapeutics, Inc. (Nasdaq: SPRO), the biopharmaceutical company announced today that its development partner, GSK, has filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic. This drug is specifically aimed at treating complicated urinary tract infections (cUTI), including pyelonephritis.
Financial Implications of the NDA Resubmission
The NDA filing is poised to trigger a $25 million milestone payment to Spero, expected to be received in the first quarter of 2026. This payment underscores the financial strength that can potentially bolster Spero's pipeline of treatments for multi-drug resistant (MDR) bacterial infections.
Details on the Clinical Trials
This NDA resubmission is supported by compelling results from the Phase 3 PIVOT-PO trial (NCT number – NCT06059846). Notably, the trial was halted early for efficacy in May 2025 upon a planned interim analysis. The results were subsequently showcased as a late breaker at the IDWeek conference in October 2025, further validating the therapeutic potential of tebipenem HBr.
Licensing and Research Support
Spero Therapeutics has granted GSK an exclusive license to commercialize tebipenem HBr across most global regions, with the exception of certain territories in Asia where Meiji holds the rights for development and commercialization. The research supporting tebipenem HBr has also been partially funded by federal resources, including support from the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.
Company Overview and Future Outlook
Spero Therapeutics is headquartered in Cambridge, Massachusetts, and is dedicated to creating novel treatments for rare diseases and MDR bacterial infections that currently present substantial unmet medical needs. For more information on Spero, visit www.sperotherapeutics.com.
Forward-Looking Statements
This announcement contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These include expectations regarding the timing of the aforementioned milestone payment and the future prospects of tebipenem HBr. Various uncertainties may affect Spero's operations, including potential regulatory hurdles and commercial acceptance of tebipenem HBr.