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GSK Resubmits NDA, Triggering Milestone for Spero Therapeutics

Story Highlights
  • Spero’s partner GSK resubmitted an FDA New Drug Application for tebipenem HBr for complicated urinary tract infections.
  • The NDA resubmission triggers a $25 million milestone payment to Spero, bolstering finances but with outcomes still subject to regulatory and market risks.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
GSK Resubmits NDA, Triggering Milestone for Spero Therapeutics

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Spero Therapeutics ( (SPRO) ) has provided an update.

On December 19, 2025, Spero Therapeutics reported that its partner GlaxoSmithKline resubmitted a New Drug Application to the U.S. Food and Drug Administration for tebipenem HBr, an oral carbapenem antibiotic candidate for the treatment of complicated urinary tract infections, including pyelonephritis. The resubmission activates a $25 million milestone payment to Spero under its license agreement with GSK, strengthening the company’s near-term cash position and underscoring the strategic importance of tebipenem HBr within its pipeline and its broader positioning in the anti-infectives market, while the program’s ultimate commercial and regulatory outcomes remain subject to significant clinical, regulatory, and execution risks.

The most recent analyst rating on (SPRO) stock is a Hold with a $4.00 price target. To see the full list of analyst forecasts on Spero Therapeutics stock, see the SPRO Stock Forecast page.

Spark’s Take on SPRO Stock

According to Spark, TipRanks’ AI Analyst, SPRO is a Neutral.

Spero Therapeutics is currently facing significant financial and operational challenges, as evidenced by declining revenues, negative profit margins, and operational inefficiencies. Technical analysis suggests ongoing bearish momentum, while valuation metrics highlight financial struggles due to a negative P/E ratio. The earnings call highlighted promising developments in their tebipenem HBr program, but these are offset by setbacks in other trials and increased financial losses. The overall score reflects these mixed but predominantly negative factors.

To see Spark’s full report on SPRO stock, click here.

More about Spero Therapeutics

Spero Therapeutics, Inc. is a biopharmaceutical company focused on developing novel anti-infective therapies, with a key program centered on tebipenem HBr, an investigational oral carbapenem antibiotic targeting complicated urinary tract infections, including pyelonephritis, through a licensing and development partnership with GlaxoSmithKline.

Average Trading Volume: 636,044

Technical Sentiment Signal: Buy

Current Market Cap: $130.1M

Find detailed analytics on SPRO stock on TipRanks’ Stock Analysis page.

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