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.
SPRO stock is up nearly 15% as of Wednesday morning but still down 91% since the start of the year.
Investors searching for all of the latest stock market news are in luck!
We’ve got them covered with our daily dives into the stock market. For Wednesday, that includes what has shares of software stocks, Pinterest (NYSE:PINS) and Coupa Software (NASDAQ:COUP) on the move today. You can get up to speed on that news at the links below!
More Wednesday Stock Market News
- Why Are Software Stocks Climbing Higher Today?
- Pinterest (PINS) Stock Pops on Wolfe Research Upgrade
- Coupa (COUP) Stock Gains 10% on Strong Earnings, Stock Buyback
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.