Iterum Therapeutics (ITRM) Stock Flies On Positive FDA Meeting

Iterum Therapeutics ITRM Stock News

Iterum Therapeutics PLC (NASDAQ: ITRM) is running for the top in the market this moring, and for good reason. The comapny announced that a pre-NDA meeting with the FDA went well, resulting in gains in multiples. Here’s what’s going on:

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ITRM Stock Gains In Multiples

As mentioned above, Iterum Therapeutics announced that a pre-NDA meeting with the FDA went well. As a result, ITRM said that it will proceed with the NDA submission for sulopenem etzadroxil/probenecid.

The treatment is being developed as a potential option for patients with uncomplicated urinary tract infections in patients with a quinolone-resistant pathogen. In a statement, Corey Fishman, CEO at ITRM, had the following to offer:

We are pleased with the collaborative tone of our meeting with the FDA, and we believe that we now have a solid understanding of the Agency’s requirements for our submission and the focus of their review.

Based on feedback received during this meeting and from previous correspondence, we have confidence in our decision to move forward with our NDA package for sulopenem etzadroxil/probenecid for the treatment of uUTI due to quinolone-resistant pathogens. We estimate that there are over 6 million quinolone-resistant urinary tract infections annually in the U.S., many of which are also multi-drug resistant, and sulopenem has demonstrated superiority versus ciprofloxacin in treating these infections.

This Is Big News

The news released by Iterum Therapeutics proved to be overwhelmingly positive. Let’s not forget, the UTI treatment market is expected to grow to be worth nearly $10 billion per year relatively soon. At the same time, ITRM stock trades with a market cap of around $13 million and is planning on submitting an NDA that, if approved, will allow it to tap into this market.

Now, the company isn’t going to take 100% of the market or anywhere near that. It may not even penetrate more than 10%, but it doesn’t have to. We’re talking about a company with a market cap of just $13 million. As a result, tapping into just 1% of the UTI market would be a massive move for the company. As a result, ITRM stock is one to watch.

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