H.C. Wainwright Downgrades Iterum Therapeutics (ITRM) to Neutral
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H.C. Wainwright analyst Ed Arce downgraded Iterum Therapeutics (NASDAQ: ITRM) from Buy to Neutral following the CRL.
The analyst commented, "This morning, Iterum announced that it received a CRL for oral sulopenem on Friday, July 23. Recall, on July 1, Iterum was notified by the agency of certain undisclosed deficiencies with the sulopenem NDA, and as such, we are not surprised that the FDA has determined that it cannot approve the NDA in its present form (See FDA Flags Deficiencies in Sulopenum NDA; Approval on July 25 PDUFA at Risk; Maintain Buy). However, the FDA has also determined that additional data are necessary to support approval for the intended indication of "the treatment of adult women with uncomplicated urinary tract infections (uUTIs) caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone". The FDA recommends that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Admittedly, we did not expect nor surmise that—with less than four weeks before the PDUFA—the "deficiencies" could entail a new clinical trial, which pushes the potential timeline to market back substantially. In a further surprise to us, the FDA also recommends that Iterum conduct further pre-clinical work to determine the optimal dosing regimen. Amidst a major delay to sulopenem's potential approval, we downgrade the shares of Iterum to Neutral from Buy."
Shares of Iterum Therapeutics closed at $1.13 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, Downgrades
Related EntitiesPDUFA, H.C. Wainwright, Ed Arce, FDA
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