Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics plc (Nasdaq: ITRM) has announced an increase in its public offering to 34,782,609 ordinary shares at $1.15 each, aiming to raise approximately $40 million. The funds will support the New Drug Application review for oral sulopenem, pre-commercialization, and operational expenses. The offering closes around February 8, 2021, pending customary conditions. With this offering, Iterum anticipates its funds will last into Q3 2022, covering expenses until the FDA's review completion date of July 25, 2021.

Iterum Therapeutics plc (Nasdaq: ITRM) announced an underwriting agreement with H.C. Wainwright & Co. to sell 8,695,653 ordinary shares at $1.15 each, potentially raising approximately $10 million. An additional 1,304,347 shares may be purchased by the underwriter. Proceeds will primarily support the review of its New Drug Application for oral sulopenem, pre-commercialization activities, and working capital. The offering is expected to close around February 8, 2021. The company anticipates sufficient funds to support operations into Q1 2022, but warns of inherent risks to projections.

Iterum Therapeutics (Nasdaq: ITRM) announced a partnership with EVERSANA™ to initiate pre-launch activities for its oral sulopenem, targeting uncomplicated urinary tract infections (uUTIs). The FDA accepted the New Drug Application (NDA) for sulopenem, with a priority review and a PDUFA date set for July 25, 2021. The collaboration aims to enhance market access, strategic marketing, and medical education, preparing for a potential late 2021 launch. The CEO expressed confidence in EVERSANA's capabilities to support an effective launch of this antibiotic aimed at combating multi-drug resistant pathogens.

Iterum Therapeutics announced that the FDA accepted its New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). This application has been designated for priority review, with a PDUFA goal date of July 25, 2021. If approved, sulopenem would be the first oral penem in the U.S. and the first new treatment for uUTIs in over 20 years, addressing the issue of quinolone resistance in millions of U.S. cases annually. The NDA includes positive data from Phase 3 clinical trials demonstrating superior efficacy compared to ciprofloxacin.

Dublin-based Iterum Therapeutics plc (Nasdaq: ITRM) is set to participate in the virtual H.C. Wainwright BioConnect Conference from January 11-14, 2021. CEO Corey Fishman will present a company overview and business update, available on-demand starting January 11 at 6:00 a.m. Eastern Time. Iterum focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens. Their leading compound, sulopenem, is in Phase 3 clinical development and has received Fast Track and QIDP designations for its oral and IV formulations in seven indications.

On December 21, 2020, Iterum Therapeutics announced the resignation of Chief Scientific Officer Dr. Michael Dunne, who will continue as a strategic advisor and board member. Dr. Steve Aronin, Senior Vice President and Head of Clinical Development, will assume leadership of development and regulatory activities. The company submitted its New Drug Application (NDA) for oral sulopenem to the FDA in November 2020, aiming for a decision in Q3 2021. Iterum is focused on combating multi-drug resistant infections.

Iterum Therapeutics has announced its transfer from the Nasdaq Global Market to the Nasdaq Capital Market, effective December 23, 2020. This decision follows the company's compliance issues regarding the Bid Price Rule, as it has until March 23, 2021, to maintain a closing share price of $1.00 for 10 consecutive days. However, the company has regained compliance with the MVPHS Rule, meeting the market value requirement. The company is focused on developing antibiotics to treat infections caused by multi-drug resistant pathogens and is currently advancing its lead compound, sulopenem, in Phase 3 clinical development.

Iterum Therapeutics announced the filing of a U.S. patent application for a bilayer tablet formulation of sulopenem etzadroxil and probenecid, which if approved, could grant patent coverage until 2039. The application aims to enhance the commercial viability of their product targeting multi-drug resistant infections. The company received positive feedback from the International Search Authority, indicating novelty in several claims. They plan to pursue additional patents internationally, supporting potential partnerships.

Iterum Therapeutics has submitted a New Drug Application (NDA) to the FDA for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) caused by quinolone non-susceptible pathogens. This submission is pivotal, as it could introduce the first oral penem antibiotic in the U.S. in over two decades. The NDA includes successful data from three phase 3 clinical trials, showing oral sulopenem's superiority over ciprofloxacin. If approved, it could address the needs of over 6 million patients annually suffering from cipro-resistant UTIs.