Business
Protara Therapeutics Announces Third Quarter 2021 Financial Results and Business Overview
– TARA-002 Confirmatory Large-Scale GMP Comparability Complete – – U.S. FDA Cleared the Company’s IND Application for TARA-002 in NMIBC; Company Plans to
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"– TARA-002 Confirmatory Large-Scale GMP Comparability Complete – – U.S. FDA Cleared the Company’s IND Application for TARA-002 in NMIBC; Company Plans to Initiate Phase 1 Clinical Trial by Year-End – – Strong Cash, Cash Equivalents, and Marketable Debt Securities of $138.4M as of September 30, 2021 – NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the third quarter ended September 30, 2021 and provided a business update. “We have made significant progress advancing our TARA-002 clinical programs in the third quarter, most notably the completion of our confirmatory large-scale GMP comparability work and the clearance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for our non-muscle invasive bladder cancer (NMIBC) clinical development program. NMIBC is one of the most recurrent and difficult to treat cancers with limited treatment options, and we look forward to initiating our Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of the year,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We are also working to align with the FDA on the design of a clinical trial of TARA-002 in patients with lymphatic malformations (LMs), a rare pediatric indication for which there are currently no U.S. FDA-approved therapies.” Recent Highlights and Upcoming Milestones TARA-002 in NMIBC In October 2021, Protara announced that the FDA cleared the Company’s IND application for TARA-002, an investigational cell-based therapy in development for the treatment of NMIBC. The confirmatory, GMP-scale comparability data for TARA-002 in relation to OK-432, the originator therapy for TARA-002, have been completed and were reviewed by the FDA as part of the clearance of the IND.The Company plans to commence a Phase 1 clinical trial by the end of 2021 to assess the safety, tolerability, and preliminary signs of anti-tumor activity of TARA-002 in adults with high-grade NMIBC. TARA-002 in LMs In October 2021, the Company updated its IND submission for TARA-002 for the treatment of LMs with completed confirmatory, GMP-scale comparability data, and plans to engage the FDA on the desig...