Business
Protara Therapeutics Announces Third Quarter 2020 Financial Results and Business Overview
- On Track to Complete GMP Batch Runs in Mid-2021 to Confirm Comparability Between TARA-002 and OK-432 -- Expect to Initiate Phase 1 Trial for TARA-002 in
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"- On Track to Complete GMP Batch Runs in Mid-2021 to Confirm Comparability Between TARA-002 and OK-432 -- Expect to Initiate Phase 1 Trial for TARA-002 in Patients with Non-Muscle Invasive Bladder Cancer in 2021 -- Requested Meeting with FDA to Discuss Path Forward for TARA-002 in Lymphatic Malformations -- Strong Cash Position of $166M as of September 30, 2020 -\n NEW YORK, Nov. 12, 2020 (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 third quarter ended September 30, 2020. “The third quarter marked a highly productive time for the Company, notably with the Food and Drug Administration’s (FDA) confirmation of initial comparability between TARA-002 and OK-432, and separately the Company’s identification of an acceptable development path for TARA-002 in non-muscle invasive bladder cancer (NMIBC), an oncology indication with high unmet need,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We believe TARA-002 has the potential to serve as a much needed intervention for NMIBC patients lacking alternative therapeutic options, and we look forward to the expected commencement of our clinical program in NMIBC in 2021. Finally, we have requested a meeting with the FDA Division of Vaccines and Related Products, the review division which the Investigational New Drug (IND) application was initially opened by the University of Iowa, to discuss a potential Biological License Application (BLA) filing for TARA-002 in lymphatic malformations (LMs).” Recent Highlights TARA-002 In September 2020, Protara announced the following updates for the TARA-002 program: FDA Confirmation of Initial Comparability Between TARA-002 and OK-432. Following a pre-IND engagement with the Office of Tissues and Advanced Therapies (OTAT) division of the Center for Biologics Evaluation and Research (CBER), the FDA agreed that Protara has successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432 and that the in-process and release protocols employed by Protara to demonstrate initial comparability are appropriate to utilize for GMP-Scale comparability testing. Good Manufacturing Practice (GMP) scale-up is currently in proce...