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ITRM

Iterum Therapeutics

$5.63

0.16 (2.93%)

07:05
03/19/19
03/19
07:05
03/19/19
07:05

Iterum Therapeutics receives QIDP for oral, IV sulopenem in four new indications

Iterum Therapeutics announced that the FDA has granted qualified infectious disease product, or QIDP, to the oral and intravenous, or IV, formulations of sulopenem in four new indications, community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis and pelvic inflammatory disease. These new designations augment Iterum's existing QIDP designations for oral and IV sulopenem for the treatment of uncomplicated urinary tract infection, or uUTI, complicated urinary tract infection, or cUTI, and complicated intra-abdominal infection, or cIAI, which the FDA granted in 2017. The company is currently conducting three pivotal Phase 3 clinical trials in uUTI, cUTI and cIAI, and expects to report top-line results in the second half of 2019. Fast track designation for all seven of these indications in both the oral and intravenous formulations has also been granted.

  • 19

    Mar

ITRM Iterum Therapeutics
$5.63

0.16 (2.93%)

06/19/18
LEER
06/19/18
INITIATION
Target $18
LEER
Outperform
Iterum Therapeutics initiated with an Outperform at Leerink
Leerink analyst Ami Fadia initiated Iterum Therapeutics with an Outperform and $18 price target.
06/19/18
NEED
06/19/18
INITIATION
Target $20
NEED
Buy
Iterum Therapeutics initiated with a Buy at Needham
Needham analyst Alan Carr initiated Iterum Therapeutics with a Buy rating and a price target of $20, saying the company's sulopenem antibiotic addresses the unmet need for treatment of urinary tract infections. The analyst anticipates a phase 3 initiation for sulopenem in the second half of this year and a launch by the first quarter of 2021, estimating peak U.S. sales reaching $700M by 2033.
06/19/18
RBCM
06/19/18
INITIATION
Target $24
RBCM
Outperform
Iterum Therapeutics initiated with an Outperform at RBC Capital
RBC Capital analyst Gregory Renza initiated Iterum Therapeutics with an Outperform rating and a price target of $24. The analyst cites the company's sulopenem treatment becoming a viable therapeutic option for resistance pathogens in the "high-opportunity" UTI market. The analyst adds that a "clear pivotal path" for the antibiotic gives the stock price the appreciation potential.
06/19/18
06/19/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Ollie's Bargain Outlet (OLLI) initiated with a Hold at Loop Capital. 2. B&G Foods (BGS) assumed with a Neutral at Piper Jaffray. 3. Iterum Therapeutics (ITRM) initiated with an Outperform at RBC Capital and Leerink while being initiated with a Buy at Needham and Guggenheim. 4. Ingersoll-Rand (IR) initiated with an Outperform at Cowen. 5. Ally Financial (ALLY) initiated with a Neutral at Nomura Instinet. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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