Iterum Therapeutics (NASDAQ:ITRM) Stock Takes a Hit: A Good Buy Opportunity?

Clinical-stage pharmaceutical company, Iterum Therapeutics (NASDAQ:ITRM), on July 26th, 2021 announced receiving Response Letter from the U.S. Food and Drug Administrationon its New Drug Application for sulopenemetzadroxil/probenecid (oral sulopenem) on July 23, 2021.The company’s shares dipped by 44% in the previous trading session.

The letter states that FDA had finished its review and has assessed that it could not approve the application in its current form.

Iterum, which is focusing on developing next generation oral and IV antibiotics for treating infections, was written by FDA that the trial showed significant difference in overall response rate of oral sulopenemvis-à-vis ciprofloxacin in the ciprofloxacin-resistant population.

FDA suggested that more data is necessary for approving it as a treatment for adult women suffering from uncomplicated urinary tract infections. Furthermore, it recommended that the company conductsat least one additional adequate clinical trial and nonclinical investigation for determining optimal dosing regimen.

The letter does not identify any safety issues pertaining to manufacturing. CEO Corey Fishman said that the outcome is a little disappointing and the company believes that the data submitted was sufficient for approval of oral sulopenem.

Fishman will be evaluating the concerns and hoped to make an expedited path forward. The company also said that it has cash, cash equivalent and short-term investments to the tune of $100.5 million by end of quarter one in 2021. The firm opines it is well positioned for funding its operations in the second half of 2023.

Market Reaction:

On Monday, ITRM stock slumped 44.20% at $0.6305 with more than 59.64 million shares, compared to its average volume of 12.91 million shares. The stock has moved within a range of $0.6300 – 0.7788 after opening the trade at $0.6950. Over the past 52-week, the stock has been trading within a range of $0.4510 – 2.9950.