Iterum Therapeutics plc (ITRM) has been notified by the FDA that an Advisory Committee meeting to review the company’s new drug application for Sulopenem etzadroxil/probenecid is no longer necessary.
Sulopenem etzadroxil/probenecid, referred to as Oral Sulopenem, is an antibiotic therapy proposed for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.
The Advisory Committee meeting to review Oral Sulopenem was scheduled for June 2, 2021.
Now that Sulopenem etzadroxil/probenecid is not going to be reviewed by an FDA panel, it is one step closer to the FDA decision, which is expected on July 25, 2021.
Iterum has collaboration with EVERSANA, a provider of commercial services to the life science industry, to support Oral Sulopenem launch.
If approved, Oral Sulopenem is expected to achieve peak sales of $300 million, according to analysts. The company believes that Oral Sulopenem has the potential to achieve blockbuster status.
As of March 31, 2021, Iterum’s cash on hand totaled $100.5 million.
ITRM has traded in a range of $0.45 to $4.65 in the last 1 year. The stock closed Thursday’s trading at $1.23, up 3.36%. In after-hours, the stock was up over 24% at $1.53.
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