Probenecid

Iterum Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023

DUBLIN, Ireland and CHICAGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 reported financial results for the third quarter ended September 30, 2023.
  • Iterum expects to report top-line data early in the first quarter of 2024 and, subject to its analysis of the data, to resubmit its New Drug Application (NDA) in the second quarter of 2024.
  • Research and development (R&D) expenses for the third quarter 2023 were $14.9 million, compared to $4.4 million for the same period in 2022.
  • Iterum will host a conference call today, Tuesday, November 14, 2023 at 8:30 a.m. Eastern Time.

Iterum Therapeutics Announces Completion of Enrollment in its REASSURE Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
Tuesday, October 24, 2023

DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
  • “We are extremely pleased to have completed enrollment in our REASSURE trial well ahead of schedule.
  • We now expect topline results early in the first quarter of 2024, and subject to our analysis of the data, plan to resubmit our NDA to the FDA in the second quarter of 2024,” said Corey Fishman, Chief Executive Officer.
  • Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the second half of 2024).

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023

OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

Iterum Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Friday, August 11, 2023

DUBLIN, Ireland and CHICAGO, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • Research and development (R&D) expenses for the second quarter 2023 were $9.0 million, compared to $4.0 million for the same period in 2022.
  • General and administrative (G&A) expenses for the second quarter 2023 were $1.9 million, compared to $4.1 million for the same period in 2022.
  • Net loss for the second quarter 2023 was $12.2 million, compared to a net loss of $6.7 million for the same period in 2022.
  • Non-GAAP1 net loss for the second quarter 2023 was $10.0 million, compared to a non-GAAP1 net loss of $5.7 million for the same period in 2022.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 16, 2023

DUBLIN, Ireland and CHICAGO, March 16, 2023 (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 reported financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Patents Issued: The United States Patent and Trademark Office has issued Iterum two new patents: 1) US Patent No.
  • In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”).
  • Non-GAAP1 net loss for the fourth quarter and full year 2022 of $6.4 million and $22.9 million, respectively, compared to a non-GAAP1 net loss of $3.3 million and $19.4 million for the same periods in 2021.
  • Iterum will host a conference call today, Thursday, March 16, 2023 at 8:30 a.m. Eastern Time.

Vistagen Provides Corporate Update and Reports Fiscal 2023 Third Quarter Financial Results

Retrieved on: 
Tuesday, February 7, 2023

“Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Should Vistagen resume PALISADE-2, the proposed amendments are intended to address various methodological issues believed to have contributed to the unexpected results of PALISADE-1.
  • Vistagen anticipates reporting topline results from this exploratory Phase 2A AjDA trial by the end of the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its third quarter fiscal year 2023 ended December 31, 2022 and provide a corporate update.

Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem

Retrieved on: 
Thursday, December 15, 2022

If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer.

Key Points: 
  • If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer.
  • The recently issued U.S. patent for oral sulopenem entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires in 2039, absent any extensions.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Fresenius Kabi Introduces Pralatrexate Injection for the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

Retrieved on: 
Thursday, December 8, 2022

Fresenius Kabi announced today it has introduced Pralatrexate Injection, a generic equivalent to Folotyn, for the treatment of relapsed or refractory peripheral T-cell lymphoma.

Key Points: 
  • Fresenius Kabi announced today it has introduced Pralatrexate Injection, a generic equivalent to Folotyn, for the treatment of relapsed or refractory peripheral T-cell lymphoma.
  • (Photo: Business Wire)
    Fresenius Kabi is committed to expanding access to high-quality, high-value oncology medicines, said John Ducker, president and CEO of Fresenius Kabi USA.
  • Fresenius Kabi Pralatrexate Injection provides clinicians and patients with a generic treatment option for adult patients with relapsed or refractory peripheral T-cell lymphoma.
  • Fresenius Kabi Pralatrexate Injection is available in two single-dose vial presentations: 20 mg/1 mL and 40 mg/2 mL.

Vistagen Announces Publication in Cells Demonstrating AV-101’s Potential for Treating Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease

Retrieved on: 
Thursday, November 17, 2022

While L-Dopa remains the most effective pharmacotherapy for Parkinsons disease, the occurrence of LID is difficult to manage and drastically interferes with Parkinsons patients quality of life.

Key Points: 
  • While L-Dopa remains the most effective pharmacotherapy for Parkinsons disease, the occurrence of LID is difficult to manage and drastically interferes with Parkinsons patients quality of life.
  • This preclinical study showed that AV-101 reduced LID with no adverse effects of treatment, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Dr. Di Paolo has been at the forefront of research in neuropharmacology and treatments for Parkinsons disease for decades.
  • MPTP is a neurotoxin that kills dopaminergic neurons in the striatum, producing motor symptoms similar to those of PD.

Iterum Therapeutics Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022

DUBLIN, Ireland and CHICAGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (“Iterum”), 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 reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 reported financial results for the third quarter ended September 30, 2022.
  • U.S. Patent Issued Extending Protection: The United States Patent and Trademark Office (USPTO) has issued Iterum a new patent, No.
  • Research and development (R&D) expenses for the third quarter of 2022 were $4.4 million compared to $1.8 million for the same period in 2021.
  • General and administrative (G&A) expenses for the third quarter of 2022 were $2.7 million compared to $3.0 million for the same period in 2021.