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

    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.

  • Is This Why The Iterum Therapeutics (ITRM) Stock Fell Pre-Hours Today?

    Iterum Therapeutics plc (ITRM) fell -43.37% to $0.64 at the last check in premarket trading sessions on Monday. To complete the last trading session, ITRM stock declined by -2.59% to $1.13. There was a price range between $1.0761 and $1.17 for Iterum shares. On average, ITRM traded 13.67 million shares daily over the last 100 days, which was above its volume of 12.07 million shares traded on the day.

    Over the last five days, ITRM shares have lost -2.59 percent, while they have lost -43.78% over the last month. Since the ITRM stock is falling in absence of any current news, we can draw our attention to recent developments to gain a better understanding of ITRM.

    Have things been going well at Iterum Therapeutics lately?

    Known for developing differentiated anti-infectives aimed at combating the global challenge of multi-drug resistant pathogens, ITRM stock mission is to significantly improve the health and wellbeing of patients suffering from life-threatening diseases around the globe. ITRM is in Phase 3 clinical development of sulopenem, a drug compound for anti-infective agents that is derived from penems, with an oral and IV formulation. Various gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics have shown potent in vitro activity against sulopenem.

    A letter was recently received by Iterum from the US Food and Drug Administration (“FDA”).

    • As part of its ongoing review of ITRM stock New Drug Application (NDA), the FDA noted deficiencies that prevent the continuation of discussions about labeling and post-marketing requirements while the assessment of the NDA is ongoing.
    • FDA’s notification did not contain any information concerning deficiencies.
    • Additionally, the letter states a decision has not yet been made regarding the information being reviewed.
    • In a letter dated January 21, 2021, the FDA assigned a target date of July 25 for the completion of its review of the NDA under the Prescription Drug User Fee Act (“PDUFA”).
    • ITRMS aims to work with the FDA to understand the specific issues and resolve them quickly.

    How ITRM will be rectifying the deficiencies?

    Despite being disappointed by this news, ITRM stock management remains confident in sulopenem’s ability to help address the growing problem of antibiotic resistance. As a result, ITRM set out to work with the FDA to identify and resolve the issues efficiently to encourage its continued advancement.

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. ITRM stock is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. The NDA for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen has been accepted for review by the FDA and a PDUFA goal date of July 25, 2021, has been assigned to it.

  • Here is why Iterum Therapeutics plc (ITRM) stock plummeted on Thursday?

    Iterum Therapeutics plc (ITRM) shares plunged 39.74% in after-hours on Thursday, July 1, 2021, and closed the day at $1.38 per share. earlier in the morning session, ITRM’s stock lost 0.87% to close Thursday’s normal session at $2.29 per share. ITRM shares have risen 92.44% over the last 12 months, and they have moved up 12.81% in the past week. Over the past three months, the stock has gained 56.85%, while over the past six months, it has declined 140.55%.

    Let’s have a look at ITRM recent developments.

    Recent Regulatory Update about sulopenemetzadroxil/probenecid

    On July 01, 2021, Iterum Therapeutics plc received a letter from the U.S. Food and Drug Administration (FDA) stating that as part of their ongoing review of the Company’s New Drug Application (NDA) for sulopenemetzadroxil/probenecid.

    The FDA identified deficiencies that prevent the continuation of the discussion of labeling and post-marketing requirements. The notification does not reflect a final decision on the information under review and FDA has set July 25, 2021, for completion of its review of the NDA.

    Recent financial results

    On May 14, 2021, Iterum Therapeutics plc announced its financial results for the first quarter ended March 31, 2021.

    Q1 2021 financial highlights

    • Research and development expenses were $2.5 million inQ1 2021 compared to $9.7 million for the same period in 2020.
    • General and administrative expenses were $3.4 million in Q1 2021 compared to $3.2 million in Q1 2020.
    • Iterum suffered from a non-GAAP net loss of $6.1 million in Q1 2021 compared to a non-GAAP net loss of $13.4 million for Q1 2020.
    • Iterum reported a net loss of $98.9 million in Q1 2021 compared to a net loss of $16.1 million in Q1 2020.
    • Net loss per share attributable to ordinary shareholders, basic and diluted was $0.81 in Q1 2021 compared to $1.08 in Q1 2020.
    • Iterum had cash, cash equivalents and short-term investments of $100.5 million on March 31, 2021. 

    Participation in the investor and health conferences

    Iterum Therapeutics participated in the 20th Annual Needham Virtual Healthcare Conference which held on Thursday, April 15, 2021. The company was presented by Chief Executive Officer, Corey Fishman.

    The company took part in HC Wainwright Global Life Sciences Conference which held on March 9, 2021.

    The company also participated in SVB Leerink Annual Global Healthcare Conference which held on Thursday, February 25, 2021.

    New Board member

    On March 16, 2021, Iterum Therapeutics appointed Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron, who left the Board on March 12, 2021. Ms. Hecht will also serve as a member of the Audit Committee and Compensation Committee of the Board.

    Conclusion

    The recent letter from the FDA identifying the deficiencies in its NDA for sulopenemetzadroxil was the reason behind its poor performance on Thursday. ITRM can face more headwinds on Friday as well.