Iterum Therapeutics Plc

Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem to be potentially the first and only oral and intravenous branded penem available. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

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Iterum Therapeutics progresses with sulopenem, faces regulatory challenges

Iterum Therapeutics (ITRM) showcased progress in key areas like FDA interactions, patent approvals, and maintaining a strong financial position.
While challenges exist in regulatory approval and funding, the company's strategic vision and commitment to growth offer opportunities for success.
Overall, Iterum's focus on advancing sulopenem for uncomplicated UTIs and engaging with the FDA reflects a promising trajectory for future growth.

Iterum Therapeutics reports improved Q3 performance with ORLYNVAH FDA approval

Iterum Therapeutics showed improved financials with lower expenses and a better net loss.
ORLYNVAH's FDA approval and market exclusivity offer growth potential in addressing UTIs.
Challenges lie in maintaining market exclusivity, international expansion, and strategic partnerships.
Opportunities include leveraging ORLYNVAH's approval, expanding internationally, and forming key partnerships.

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Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

DUBLIN, Ireland and CHICAGO, Feb. 03, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,695,653 ordinary shares (or pre-funded warrants in lieu thereof) at a public offering price of $1.15 per share, less underwriting discounts and commissions. In addition, the Company has granted the underwriter an option for a period of 30 days to purchase up to an additional 1,304,347 ordinary shares on the same terms and conditions. All of the shares (or pre-funded warrants) are being offered by the Company. The offering is expected to close on or about February 8, 2021, subject to the satisfaction of customary closing conditions.

Iterum Therapeutics plc Announces $10 Million Bought Deal Public Offering of Ordinary Shares

DUBLIN, Ireland and CHICAGO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced it has engaged EVERSANA™, a leading provider of commercial services to the life science industry, to immediately initiate pre-launch activities, followed by planned commercialization services upon final agreement.

Iterum Therapeutics Announces Collaboration with EVERSANA to Support Oral Sulopenem Launch

-- If approved, First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years -- -- PDUFA goal date of July 25, 2021 --

Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

DUBLIN, Ireland and CHICAGO, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that management will participate in the H.C. Wainwright BioConnect Conference being held virtually from January 11-14, 2021. Corey Fishman, Chief Executive Officer, will provide a company overview and business update. The Company's presentation will be available on-demand through the H.C. Wainwright conference portal, beginning on Monday, January 11th at 6:00 a.m. Eastern Time.

Iterum Therapeutics to Participate in H.C. Wainwright BioConnect Virtual Conference

--Dr. Dunne resigns as Chief Scientific Officer-- -- Steven Aronin, M.D., Senior Vice President and Head of Clinical Development, to lead Development and Regulatory Activities --

Iterum Therapeutics Announces Transition of Michael Dunne, M.D. to Strategic Advisor and Member of the Board of Directors

Trading on Nasdaq Capital Market is expected to begin on December 23, 2020 Trading on Nasdaq Capital Market is expected to begin on December 23, 2020

Iterum Therapeutics Receives Approval to Transfer to Nasdaq Capital Market

Bilayer tablet patent application could provide U.S. patent coverage for Iterum's commercial formulation through 2039, if granted Bilayer tablet patent application could provide U.S. patent coverage for Iterum's commercial formulation through 2039, if granted

Iterum Therapeutics Announces Filing of US Patent Application Based on Favorable Written Opinion of the International Search Authority

Iterum Therapeutics (ITRM) is in the news Thursday following news of massive stakes in the company pushing ITRM stock higher. The post Iterum Therapeutics News: Why ITRM Stock Is Rocketing Higher Today appeared first on InvestorPlace.

Iterum Therapeutics News: Why ITRM Stock Is Rocketing Higher Today

-- F irst O ral Penem in the U . S . and First New Oral Treatment for uUTI s in Over 20 Years , if approved - - - - Potential Approval Q3 2021 with Priority Review --

Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

NDA Filing Expected Q4 2020 NDA Filing Expected Q4 2020

Iterum Therapeutics Reports Third Quarter 2020 Financial Results

DUBLIN, Ireland and CHICAGO, Oct. 23, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the pricing of a public offering of 26,923,076 ordinary shares (or pre-funded warrants in lieu thereof), together with warrants to purchase up to 20,192,307 ordinary shares at a combined effective price to the public of $0.65 per ordinary share (or pre-funded warrant) and associated warrant. The warrants will have an exercise price of $0.65 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about October 27, 2020, subject to the satisfaction of customary closing conditions.

Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering

Data presentations to cover both SURE-1 and SURE-2 urinary tract infection studies Data presentations to cover both SURE-1 and SURE-2 urinary tract infection studies

UPDATE -- Iterum Therapeutics to Present Data from Phase 3 Trials in Uncomplicated and Complicated Urinary Tract Infections at IDWeek 2020

Iterum Therapeutics to Present Data from Phase 3 Trials in Uncomplicated and Complicated Urinary Tract Infections at IDWeek 2020

--Preparing to Submit NDA in Q4-- DUBLIN, Ireland and CHICAGO, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that, based on discussions at a pre-NDA meeting with the U.S. Food and Drug Administration ("FDA"), it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone-resistant pathogen.

Iterum Therapeutics Announces Positive Pre-NDA Meeting with FDA for Sulopenem for Treatment of Uncomplicated Urinary Tract Infections

DUBLIN, Ireland and CHICAGO, Sept.  08, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced its participation at the 22nd Annual H.C. Wainwright Global Investment Conference. The conference will be held virtually from September 14 – 16, 2020. Corey Fishman, Chief Executive Officer, is scheduled to present an overview of the Company on Wednesday, September 16, 2020 at 10:00 a.m. ET.

Iterum Therapeutics to Present at the 22nd Annual H.C. Wainwright Global Investment Conference

DUBLIN, Ireland and CHICAGO, Sept.  02, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced revised results of its pending rights offering.

Iterum Therapeutics Announces Revised Results of Rights Offering

DUBLIN, Ireland and CHICAGO, Aug.  31, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the subscription period of its previously announced rights offering expired at 5:00 p.m., New York City time, on August 31, 2020. As previously disclosed, the Company had agreed to undertake the rights offering in connection with the Company’s January 2020 private placement of units consisting of 6.500% Exchangeable Senior Subordinated Notes due 2025 and Limited Recourse Royalty-Linked Subordinated Notes.

Iterum Therapeutics Announces Expiration and Preliminary Results of Rights Offering

--Meeting with FDA Scheduled for end of Q3-- --Meeting with FDA Scheduled for end of Q3--

Iterum Therapeutics Reports Second Quarter 2020 Financial Results

DUBLIN, Ireland and CHICAGO, July  13, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced the record date for the Company’s planned rights offering. As previously disclosed, the Company had agreed to undertake a rights offering of subscription rights to purchase additional units in connection with the Company’s January 2020 private placement of units consisting of 6.500% Exchangeable Senior Subordinated Notes due 2025 and Limited Recourse Royalty-Linked Subordinated Notes. The planned rights offering will be made only by means of a prospectus, and this announcement does not constitute an offer to sell, or a solicitation of an offer to buy, any securities.

Iterum Therapeutics Informs Shareholders of Record Date for Planned Rights Offering

DUBLIN, Ireland and CHICAGO, June  30, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 3,372,686 of its ordinary shares at a purchase price of $1.4825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules. The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,686,343 ordinary shares in a concurrent private placement. The warrants have an exercise price of $1.42 per share, are exercisable immediately, and will expire five and one-half years following the date of issuance. The closing of the offering is expected to occur on or about July 2, 2020, subject to the satisfaction of customary closing conditions. 

Iterum Therapeutics Announces $5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

Sulopenem demonstrates superiority in treatment of patients with quinolone resistant pathogens

Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections

DUBLIN, Ireland and CHICAGO, June  15, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, today announced results of its Annual General Meeting held on June 10, 2020 (the “AGM”).

Iterum Therapeutics plc Announces Result of Proposal 8 at Annual General Meeting

DUBLIN, Ireland and CHICAGO, June  03, 2020  (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 2,971,770 of its ordinary shares at a purchase price of $1.6825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules.  The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,485,885 ordinary shares in a concurrent private placement.  The warrants have an exercise price of $1.62 per share, are exercisable immediately, and will expire five and one-half years following the date of issuance.  The closing of the offering is expected to occur on or about June 5, 2020, subject to the satisfaction of customary closing conditions. 

Iterum Therapeutics Announces  $5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

Study did not meet its primary endpoint Study did not meet its primary endpoint

Iterum Therapeutics Announces Topline Results for a Phase 3 Clinical Trial of Oral and IV Sulopenem in Complicated Urinary Tract Infection

--Phase 3 topline results from sulopenem clinical trials in uUTI and cUTI expected Q2 --   -- Raised $51.6 million through a private placement with new and existing investors --

News for Iterum Therapeutics Plc Stock (ITRM)