Iterum Therapeutics plc (ITRM) has experienced an increase of 24.37% in the premarket today after ITRM Provides Update from FDA Type A Meeting Regarding Oral Sulopenem. However, the last trading session closed at $0.5548 with an increase of 0.49%.
Update from FDA Type A Meeting Regarding Oral Sulopenem
On 28th September 2021, ITRM declared that during the third quarter of 2021, the Company held a Type A meeting with the US Food and Drug Administration. It was to explain the steps required for a potential renewal of the New Drug Application. The FDA sent the company a Complete Response Letter (CRL) in July, asking for further evidence to support the approval of oral sulopenem for the treatment of adult women with an uUTI.
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Cash, cash equivalents, and short-term investments totaled $91.5 million at the end of the second quarter of 2021. The Company believes it is financially well-positioned to support its activities until the second half of 2023. It is based on its current operating plan and subject to the final determination of the design and planned conduct of future clinical and prospective nonclinical research for sulopenem.
Second Quarter 2021 Financial Results
ITRM declared a second-quarter of 2021 financial results on 13th August 2021. Iterum has $91.4 million in cash and cash equivalents as of June 30, 2021. Iterum anticipates that its current cash, cash equivalents, and short-term investment opportunities will be sufficient to finance its operations. This pertained to the current operating plan and was subordinate to the final determination of the layout.
Lastly, ITRM recorded a net income of $7.8 million in the second quarter of 2021. This owed to a non-cash adjustment related to Iterum’s Royalty-Linked Notes in the second quarter of 2021. Iterum announced a non-GAAP1 net loss of $7.2 million for the second quarter of 2021.
ITRM provides regulatory update
On 1st July 2021, ITRM revealed that the Company received a notice from the United States Food and Drug Management. The Company plans to cooperate with the FDA to determine the nature of the problems. ITRM continues to believe in the promise of sulopenem to help address the rising problem of antibiotic resistance. Lastly, their aim now is to cooperate with the FDA to identify and fix the concerns as quickly as possible.