Telix Pharmaceuticals advanced 5.2% in pre-market trading on Wednesday after the company disclosed completion of patient recruitment for its Phase 3 BiPASS study and reached an agreement with the U.S. Food and Drug Administration regarding a New Drug Application pathway.
The BiPASS trial evaluates the combination of Telix’s commercial PSMA-PET imaging agents, Illuccix and Gozellix, with MRI against standard-of-care procedures for prostate cancer detection in a pre-biopsy setting. The company also secured FDA alignment on a regulatory pathway that, if approved, could support reimbursement as a distinct new product and expand patient access beyond current labeling.
The developments follow Telix’s disclosure of solid first-half 2026 financial results in August, which showed a 22% year-over-year revenue increase and a 146% rise in EBITDA. The stock, which reached a 52-week high of $12.48, was trading at $11.42 in pre-market activity.
H.C. Wainwright reiterated its Buy rating and maintained a $20 price target, citing the clinical and regulatory progress as key value drivers. The broader market provided limited directional impetus, with the S&P 500 essentially flat and the NASDAQ down 1.03%, indicating the move was driven by company-specific news rather than sector-wide sentiment.
The SEC filing, reported on September 2, 2026, outlined the clinical trial update and FDA agreement, reinforcing Telix’s positioning in the radiopharmaceutical sector amid ongoing oncology innovation.
