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Iterum Therapeutics plc reports developments tied to its anti-infective business, its ORLYNVAH™ commercial activity, and its corporate status as a company in provisional liquidation. The company has focused on oral and IV antibiotics for infections caused by multi-drug resistant pathogens, including sulopenem and ORLYNVAH™ for uncomplicated urinary tract infections in adult women with limited or no alternative oral antibacterial treatment options.
Recurring updates include ORLYNVAH™ market access, pharmacy benefit manager and specialty-distributor contracting, patent protection for sulopenem etzadroxil and probenecid tablet technology, FDA correspondence on product claims, financial results, Nasdaq listing matters, and the Irish winding-up petition and provisional liquidator appointments.
Iterum Therapeutics (Nasdaq: ITRM) has been granted a 180-day extension by Nasdaq to regain compliance with its minimum bid price requirement, now due by September 5, 2022. The company must close at $1.00 or higher for 10 consecutive business days to meet the Bid Price Rule. If compliance is not achieved, Nasdaq may delist the company's ordinary shares, although an appeal is possible. The extension has no immediate effect on trading. Iterum aims to combat multi-drug resistant pathogens, advancing its compound sulopenem in Phase 3 clinical development.
Iterum Therapeutics plc (Nasdaq: ITRM) announced on February 8, 2022, the granting of a non-statutory share option to a new employee, comprising 50,000 ordinary shares. The share option has an exercise price of $0.41, equal to the closing price on the grant date, and a 10-year term, vesting over four years. This incentive aligns with Nasdaq regulations and forms part of the new hire's compensation package. Iterum is focused on developing advanced antibiotics, particularly sulopenem, which is in Phase 3 clinical development.
Iterum Therapeutics plc (Nasdaq: ITRM) announced the granting of a share option for 1,800,000 ordinary shares and 500,000 restricted share units to its new Chief Medical Officer, Dr. Sailija Puttagunta. Effective December 10, 2021, the share option has an exercise price of $0.48 and vests over four years. This grant is part of Dr. Puttagunta’s employment compensation and complies with Nasdaq's inducement grant exception. Iterum Therapeutics focuses on developing antibiotics to combat multi-drug resistant pathogens and is advancing its lead compound, sulopenem, in Phase 3 clinical development.
Iterum Therapeutics (Nasdaq: ITRM) announced the appointment of Dr. Sailaja Puttagunta as Chief Medical Officer, effective immediately. Dr. Puttagunta, who has over 20 years of experience in infectious diseases, will oversee global clinical development and regulatory initiatives as the company advances its antibiotic candidate, sulopenem, which is currently in Phase 3 trials. The leadership change is expected to enhance Iterum's strategies for clinical development, particularly against multi-drug resistant infections.
Iterum Therapeutics reported a productive Type A meeting with the FDA regarding the potential resubmission of its NDA for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTI). A Type B meeting has been requested to finalize the design for an additional Phase 3 trial. Financially, the company has $85.7 million in cash, sufficient to fund operations into 2024. The third-quarter net income was $3.7 million compared to a net loss of $12.2 million in 2020, supported by a significant non-cash adjustment in derivative liabilities.
Iterum Therapeutics plc (Nasdaq: ITRM) will release its Q3 2021 financial results on November 12, 2021, before U.S. markets open. A conference call will occur at 8:30 a.m. ET to discuss these results and provide a business update. The company focuses on developing antibiotics to combat multi-drug resistant pathogens. Its leading compound, sulopenem, is currently in Phase 3 clinical development, with both oral and IV formulations receiving Fast Track and QIDP designations. For more details, visit iterumtx.com.
Iterum Therapeutics (Nasdaq: ITRM) announced a productive Type A meeting with the FDA regarding the New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). Following a Complete Response Letter (CRL) from the FDA for additional data, the company is exploring options for a new Phase 3 study. As of Q2 2021, Iterum has $91.5 million in cash, sufficient to support operations into H2 2023. The company continues to pursue solutions for addressing multi-drug resistant UTIs through its anti-infective research.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a data presentation at the IDWeek 2021, taking place virtually from September 29 to October 3, 2021. The presentation, titled In Vitro Antibacterial Susceptibility Testing of Sulopenem Against Category A and B Bio-threat Bacterial Pathogens, will feature lead author Steven I. Aronin and is scheduled for September 29, 2021, during the Novel Agents poster session.
Iterum is focused on developing novel oral and IV antibiotics, particularly sulopenem, which has shown potent activity against multi-drug resistant pathogens and has received QIDP and Fast Track designations.
Bernstein Liebhard, an investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a class action lawsuit for Iterum Therapeutics (ITRM). The lawsuit claims that Iterum made misleading statements regarding its sulopenem NDA for treating urinary tract infections, impacting its stock performance. Following FDA correspondence indicating deficiencies in the NDA, Iterum's stock fell significantly. Investors must act by October 4, 2021, to participate in the lawsuit.
DUBLIN, Ireland and CHICAGO, Sept. 08, 2021 -- Iterum Therapeutics plc (Nasdaq: ITRM) announced that CEO Corey Fishman will present a company overview at the H.C. Wainwright 23rd Annual Virtual Global Investment Conference. The presentation will be available on-demand starting September 13 at 7:00 A.M. (ET). Iterum is focused on developing next-generation antibiotics, including sulopenem, targeting multi-drug resistant pathogens. The company has received QIDP and Fast Track designations for sulopenem in seven indications. For more information, visit www.iterumtx.com.