Protara Therapeutics Inc. (TARA) stock prices were up by 4.49% as of the market closing on October 11th, 2021. This brought the price per share up to USD$6.75 at the end of the trading day. Subsequent premarket fluctuations have seen the stock surge by 16.89%, bringing it up to USD$7.89.
FDA Approves TARA-002 IND
October 12th 2021 saw TARA stock announce that the U.S FDA cleared the company’s Investigational New Drug application for TARA-002. The treatment is an investigational cell-based therapy that is being developed to target non-muscle invasive bladder cancer (NMIBC). The company anticipates the initiation of a Phase 1 clinical trial for the treatment in adults with high grade NMIBC by the end of 2021. Following the approval by the United States Food and Drug Administration, the company is keen to push for the accelerated Phase 1 study.
Scope of TARA-002
TARA stock aims to fulfill the unmet need for new treatments for NMIBC. This is evidenced by significant increases in recurrence and disease progression, further exacerbated by a rising number of patients requiring cystectomies. The company is confident in TARA-002’s potential to address this need as a promising new option for NMIBC patients. This is supported by the strength of existing clinical data in NMIBC for OK-432, which is the originator therapy for TARA-002.
Details of TARA Stock’s Trial
The Phase 1 dose finding, open label trial is designed to evaluate TARA-002 in treatment naïve and treatment experienced NMIBC patients. These patients report high grade carcinoma in situ (CIS) and high grade papillary tumors (Ta). The initial dose escalation phase of the trial will see patients being administered six weekly intravesical doses of the treatment. The primary objective of the trial is to evaluate the safety, tolerability, and preliminary signs of anti-tumor activity of TARA-002. The study will have aim to establish a maximum tolerated dose and recommended dose for a future Phase 2 clinical trial. TARA-002 is manufactured from the same cell bank as OK432, which is an approved therapy in Japan and Taiwan for multiple oncologic indications.
Future Outlook for TARA Stock
TARA stock has had a solid quarter, further consolidated by the approval of its IND for TARA-002 by the U.S. FDA. The company is keen to push for the accelerated commercialization and development of its proprietary treatment. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value over the long time.