Business
Protara Therapeutics Announces Second Quarter 2021 Financial Results and Business Overview
- Successfully Completed IND-Enabling Studies for TARA-002 in Patients with NMIBC; On Track to Initiate Phase 1 Trial by Year-End - - TARA-002 GMP Scale up
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"- Successfully Completed IND-Enabling Studies for TARA-002 in Patients with NMIBC; On Track to Initiate Phase 1 Trial by Year-End - - TARA-002 GMP Scale up and Comparability Ongoing and Expected to be Completed by Year-End - - Company Plans to Engage with FDA to Determine Clinical Trial Design for TARA-002 in Lymphatic Malformations - - Strong Cash, Cash Equivalents, and Investments Position of $145M as of June 30, 2021 - NEW YORK, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, today announced financial results for the second quarter ended June 30, 2021 and provided a business update. “We continue to make significant progress executing against our development plans for TARA-002 in non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs), and we look forward to achieving multiple important milestones in the second half of this year,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “With the successful completion of required non-clinical studies for TARA-002, we remain on track to submit our Investigational New Drug (IND) application and initiate our Phase 1 clinical study by year-end. In addition, our Good Manufacturing Practice (GMP) scale up and comparability work remain on track to be completed by year-end, and we look forward to working with the U.S. Food and Drug Administration (FDA) on a clinical trial of TARA-002 in patients with LMs, a rare pediatric indication for which there are currently no U.S. FDA-approved therapies.” Recent Highlights and Upcoming Milestones TARA-002 Comparability The Company remains on track to complete confirmatory, large-scale GMP manufacturing comparability by year-end. TARA-002 in NMIBC Protara successfully completed required non-clinical IND-enabling studies to characterize local toxicity of intravesical administration of TARA-002. The Company remains on track to submit an IND application in the second half of 2021 and, subject to the FDA acceptance of the IND application, the Company plans to commence a Phase 1 trial by the end of 2021 to assess the safety and tolerability of TARA-002 in patients with NMIBC, including patients with carcinoma in situ (CIS). TARA-002 in LMs Following the...