Benzinga | Feb 4, 2021 08:24AM EST

Theratechnologies' Peptide Conjugate Candidate For Solid Tumor Nabs Priority Review Tag In US, Shares Rally

* The FDA has designated Fast Track status to Theratechnologies Inc's (NASDAQ: THTX) TH1902 as a single agent for treating patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.

* Last month, the FDA signed off Phase 1 clinical trial of TH1902, including a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD), and preliminary anti-tumor activity of TH1902 administered once every three weeks.

* Once the MTD is determined, it is planned that a total of 40 additional patients will be enrolled to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, pancreatic, and triple-negative breast cancers.

* The Phase 1 trial is expected to start in the second quarter of 2021.

* Price Action: THTX shares are trading higher by 60.7% at $3.76 in premarket trading on the last check Thursday.