Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (Nasdaq: ITRM) has announced its second quarter 2021 financial results will be released on August 13, 2021, before U.S. market opening. The management will hold a conference call at 8:30 a.m. ET to discuss the results and business updates. The company, focused on developing antibiotics for multi-drug resistant infections, is advancing its lead compound, sulopenem, through Phase 3 clinical development. Sulopenem has received QIDP and Fast Track designations in seven indications, highlighting its potential market impact.

Iterum Therapeutics (Nasdaq: ITRM) announced it received a Complete Response Letter (CRL) from the FDA regarding its NDA for oral sulopenem. The FDA determined that additional data is needed to support approval for treating urinary tract infections after acknowledging positive Phase 3 trial results. The company plans to discuss the CRL with the FDA and may conduct further clinical trials. Iterum has $100.5 million in cash and believes it can fund operations into the second half of 2023.

Iterum Therapeutics (Nasdaq: ITRM) announced it received a letter from the FDA regarding deficiencies in its New Drug Application (NDA) for sulopenem etzadroxil/probenecid. This letter halts discussions about labeling and post-marketing commitments but does not denote a final decision. The PDUFA goal date for the NDA review is July 25, 2021. CEO Corey Fishman expressed disappointment but affirmed the commitment to resolve issues with the FDA expediently. Sulopenem aims to address antibiotic resistance and has received Fast Track designations in several indications.

The Company Iterum Therapeutics plc (Nasdaq: ITRM) announced its participation in a late-cycle meeting with the FDA regarding its NDA for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated urinary tract infections. The FDA is still reviewing the application and has indicated that an Advisory Committee meeting is not necessary. The PDUFA date is set for July 25, 2021. Iterum is developing sulopenem, which has shown efficacy against drug-resistant pathogens, and holds QIDP and Fast Track designations for multiple indications.

Iterum Therapeutics plc (Nasdaq: ITRM) announced ongoing FDA review of its NDA for oral sulopenem aimed at treating uncomplicated urinary tract infections, with a PDUFA date set for July 25, 2021. The company reported a cash position of $100.5 million, expected to fund operations into the first half of 2023. First-quarter 2021 net loss surged to $98.9 million, largely due to non-cash adjustments, while R&D expenses decreased significantly to $2.5 million. Iterum has partnered with EVERSANA for commercialization efforts, anticipating a product launch in Q4 2021, pending FDA approval.

Iterum Therapeutics plc (Nasdaq: ITRM) will announce its first quarter 2021 financial results on May 14, 2021, before U.S. market open. A conference call is scheduled for 8:30 a.m. ET to discuss these results and provide business updates. The company focuses on developing next-generation antibiotics to combat multi-drug resistant infections, with its lead compound, sulopenem, in Phase 3 clinical development. Sulopenem has received Qualified Infectious Disease Product and Fast Track designations in seven indications.

Iterum Therapeutics (Nasdaq: ITRM) announced that CEO Corey Fishman will present a business update at the 20th Annual Needham Virtual Healthcare Conference on April 15, 2021, at 3:45 PM ET. The company is focused on developing oral and IV antibiotics to combat multi-drug resistant infections. Iterum is advancing sulopenem, which has shown effectiveness against resistant bacteria and received QIDP and Fast Track designations for multiple indications. For more details, visit the company’s website.

Iterum Therapeutics announces the appointment of Beth P. Hecht to its Board of Directors, replacing Patrick Heron effective March 12, 2021. Hecht brings over 25 years of experience in the life sciences sector, including her role as SVP and General Counsel at Xeris Pharmaceuticals. CEO Corey Fishman expressed confidence in Hecht's ability to guide the company as it transitions from a developmental to a commercial organization, particularly in bringing its first branded oral antibiotic for uncomplicated urinary tract infections to market.

Iterum Therapeutics (ITRM) reported Q4 and full-year 2020 financial results, highlighting notable progress on its NDA for oral sulopenem intended for urinary tract infections. The FDA's PDUFA goal date is set for July 25, 2021. The company has extended its cash runway into the first half of 2023 due to proceeds of $74.3 million from recent offerings. R&D expenses decreased significantly to $21.1 million from $90.8 million a year earlier. Iterum's net loss for 2020 narrowed to $52.0 million from $103.1 million in 2019. A conference call is scheduled for today at 8:30 am ET.