Iterum receives FDA acceptance of oral sulopenem NDA resubmission; PDUFA date Oct 25, 2024

Iterum Therapeutics plc

FDA accepted resubmission of NDA for oral sulopenem for uUTIs in adult women; PDUFA action date set for October 25, 2024.
Nasdaq granted 180-day extension until September 30, 2024 to regain compliance with minimum stockholders' equity requirement.
CMO Sailaja Puttagunta steps down effective May 31, 2024; will serve as consultant at $400/hour during regulatory review.
Resubmission includes REASSURE trial data showing oral sulopenem non-inferior to Augmentin and statistically superior for overall success.

item 5.02 item 8.01 item 9.01

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Departed

Sailaja Puttagunta

Chief Medical Officer

ITRMF · Iterum Therapeutics plc

Effective: 2024-05-31
Filed: May 31, 2024, 7:59 PM ET

Dr. Puttagunta, whose previously announced resignation as CMO is effective as of May 31, 2024

Key facts

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Executive change SEC 8-K Item 5.02 confidence 0.95

Sailaja Puttagunta resigned as Chief Medical Officer at Iterum Therapeutics plc.

Action: resigned
Role: Chief Medical Officer

Exact text from the filing

Dr. Puttagunta, whose previously announced resignation as CMO is effective as of May 31, 2024

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Iterum Therapeutics plc filing history →

Source: SEC EDGAR

accession 0000950170-24-066932

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