Iterum Therapeutics Shares Drop 40% After FDA Letter for Sulopemen NDA
By Chris Wack
Iterum Therapeutics PLC shares were down 40% to 68 cents after
the U.S. Food and Drug Administration decided it can't approve the
company's new drug application for sulopenem etzadroxil/probenecid
oral sulopenem in its present form.
Volume for the stock was 43 million shares at 12:45 p.m. ET,
compared to its 65-day average volume of 12.7 million shares. The
stock hit its 52-week of $2.99 on Feb. 11.
The FDA acknowledged in a letter Friday that the Phase 3
clinical trial demonstrated statistical significance in difference
in overall response rate of oral sulopenem compared to
ciprofloxacin in the ciprofloxacin-resistant population, Iterum
However, the FDA determined that additional data are necessary
to support approval for the treatment of adult women with
uncomplicated urinary tract infections caused by designated
susceptible microorganisms proven or strongly suspected to be
non-susceptible to a quinolone, the company said.
The FDA recommended that Iterum conduct at least one additional
adequate and well-controlled clinical trial, potentially using a
different comparator drug, the company said.
Additionally, the FDA recommended that Iterum conduct further
nonclinical investigation to determine the optimal dosing regimen,
although the FDA stated that this recommendation doesn't raise an
approvability issue, the company said.
The FDA didn't identify any chemistry, manufacturing or controls
issues, nor were there any safety issues found in over 1,800
patients treated with sulopenem across the clinical development
program, the company said.
Iterum intends to review the FDA's decision with its advisers
and plans to request a Type A meeting in the coming weeks.
Following the meeting, anticipated to be late in the third quarter,
Iterum expects to provide an update on next steps as to the
potential additional clinical and non-clinical work to be done
prior to a resubmission of the NDA for approval of oral
Iterum said it had cash, cash equivalents and short-term
investments of $100.5 million at the end of the first quarter of
2021. Based on the current operating plan and subject to final
determination of the design and planned conduct of additional
clinical and potential nonclinical development for sulopenem, the
company believes that it is well positioned financially to fund its
operations into the second half of 2023.
The company had said in May that it was aiming to launch oral
sulopenem in the fourth quarter of 2021, if approved.
HC Wainwright & Co. downgraded Iterum stock to Neutral from
Buy, with no price target, based on the FDA letter.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
July 26, 2021 13:08 ET (17:08 GMT)
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