FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Iterum Therapeutics Surges Following FDA Late-Cycle Meeting”
Iterum Therapeutics plc (NASDAQ: ITRM) surged over 17% in premarket trading after announcing that it had participated in a late-cycle meeting with the U.S. Food and Drug Administration.
The FDA has determined that an Advisory Committee meeting is not currently necessary and shared issues still under review regarding the Company’s new drug application, which is currently ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25th, 2021.
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
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