Iterum Therapeutics plc (ITRM) stock drops in Pre-Market today : Here’s to know why

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Shares of the Iterum Therapeutics plc (ITRM) stock were dropping in the pre-market trading session today on July 28, 2021, after rising to a good height in the last trade. ITRM stock price saw a decline of 6.88% to drop at $0.69 a share at the time of this writing. The penny stock went high by 17.53% at the previous closing. Let’s try to figure out the reason behind this fall.

What’s Happening?

Iterum Therapeutics plc is the clinical-stage biotechnology stock that develops anti-infectives to treat infectious diseases that cause due to multi-drug resistant pathogens.  ITRM stock is falling in pre-market today despite any obvious reason related to it. No specific news or announcement in today’s date is available to justify the bearish sentiment. ITRM stock dropped 68.73% in the last 30 days and in the past 12 months, the penny stock dropped by 32.64%. Let’s take a look at some recent events of the Iterum.

ITRM stock received Response Letter from FDA:

Iterum stock received a complete response letter(CRL) from U.S Food and Drug Administration for its new drug application(NDA) oral sulopenem on July 23, 2021. The FDA did not approve the new drug application in its present form. According to CRL, FDA acknowledged the significant statistical data of the overall response rate of the oral sulopenem against ciprofloxacin in the population resistant to ciprofloxacin. However, FDA mentioned in the CRL that this data is not sufficient and demanded additional data for the approval of the drug.

FDA recommendations to ITRM stock:

The FDA recommended Iterum stock to conduct at least one more well-controlled and adequate clinical trial by using a different comparator drug. Moreover, the recommendations also included a nonclinical investigation of the NDA in order to determine the optimal dose prescription. However, this recommendation was not connected with approvability of the drug.

Financial View of ITRM stock:

According to the first quarter 2021 financial results, Iterum stock suffered a net loss of  $98.9 million as compared to a $16.1 million net loss in the same quarter of the prior year. The penny stock spent $2.5 million and $3.4 million in R&D expenses and general and administrative expenses respectively. At the end of the first quarter, Iterum had $100.5 million in cash, cash equivalents, and short-term investments.

Wrap Up:

The penny stock is now red in Wednesday’s pre-market trading session after a strong gain in the last trade. ITRM stock has a market cap of 132.7 million and a 13,786,501 average trading volume.

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