Iterum (ITRM) Plans Early Submission of UTI Drug NDA, Stock Up [Yahoo! Finance]
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: Yahoo! Finance
a new drug application (NDA) for oral sulopenem to the FDA in the first half of the second quarter of 2024, ahead of schedule. The NDA will seek approval for the candidate to treat adult women with uncomplicated urinary tract infections (uUTIs) in the United States. Sulopenem, a thiopenem antibiotic, is being developed to treat urinary tract and intra-abdominal infections. An intravenous formulation of the candidate is also currently under development. We remind the investors that in 2021, Iterum received a complete response letter (CRL) from the FDA against its initial NDA for oral sulopenem for the uUTIs indication. Per the CRL, the NDA could not be approved in its present form and additional data was required to support the approval of oral sulopenem for the treatment of adult women with uUTIs. The FDA recommended Iterum to conduct an additional clinical study of the candidate, potentially using a different comparator drug. Following the FDA's recommendation, the company in
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News
- Iterum Therapeutics plc (NASDAQ: ITRM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $6.00 price target on the stock.MarketBeat
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial ResultsGlobeNewswire
- Iterum Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024GlobeNewswire
- Iterum Therapeutics to Participate in H.C. Wainwright Virtual @Home Fireside Chat [Yahoo! Finance]Yahoo! Finance
ITRM
Earnings
- 3/28/24 - Beat
ITRM
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- ITRM's page on the SEC website