Iterum Therapeutics (ITRM) shares gained more than 36% in recent Friday trading after the company said the US Food and Drug Administration has approved its new drug application for Orlynvah as a treatment for uncomplicated urinary tract infections in women.
The approval was based on data from its clinical development program, including the results from two phase 3 trials where Orlynvah demonstrated "superiority" to other treatments, the company said.
Iterum said the approval marks the first indication for Orlynvah, making it the company's first FDA-approved product.
Price: 1.99, Change: +0.82, Percent Change: +70.09
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.