Iterum Therapeutics Plc Stock Price, News & Analysis

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.

Iterum Therapeutics (ITRM) reported its Q2 2021 financial results, noting a net income of $7.8 million, significantly improved from a net loss of $12.5 million in Q2 2020. The increase is attributed to a non-cash adjustment related to its Royalty-Linked Notes. Following an FDA Complete Response Letter in July, Iterum is preparing for a Type A meeting with the FDA regarding the approval pathway for oral sulopenem, anticipated by late Q3 2021. The company maintains a strong cash position, with $91.4 million on hand, sufficient to fund operations into the second half of 2023.

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.