- Spero Therapeutics(SPRO) stock is getting a boost from U.S. Food and Drug Administration (FDA) news.
- That includes positive feedback for its complicated urinary tract infection (cUTI) treatment.
- The company is now planning an additional Phase 3 clinical trial of tebipenem HBr.
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Spero Therapeutics(NASDAQ:SPRO) stock is climbing higher on Wednesdaythanks to positive feedbackfrom the U.S. Food and Drug Administration (FDA).
The news concerns plans for the company to resubmit tebipenem HBr for the treatment of complicated urinary tract infection (cUTI). During a Type A meeting, the FDA said “positive results from an additional Phase 3 trial […] could be sufficient to support the approval of tebipenem HBr for cUTI.”
It’s worth noting that Spero has already conducted a Phase 3 clinical trial of tebipenem HBr for cUTI. The FDA’s suggestion is for a second Phase 3 clinical trial to further back up its results.
During that same meeting, Spero and the FDA hashed out some of the details of a new clinical trial. This could have the study being the subject of a Special Protocol Assessment. The trial will also need approval once plans are finalized.
SPRO Plans to Further Development of the Antibiotic
Spero Therapeutics notes that it intends to move forward with the clinical development and commercialization of tebipenem HBr. The company says that it will be seeking an “external partnership” as part of this effort.
News of the FDA meeting has SPRO stock seeing incredibly heavy trading on Wednesday. As of this writing, more than 38 million shares of the stock have been traded. To put that in perspective, the company’s daily average trading volume is closer to 1.6 million shares.
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