When this was written — On 4 October 2026. The figures are as at that date or earlier and have not been updated since.
Telix was 10.75% shorted on 28 September, according to ASIC’s daily aggregate report. R1 BiPASS gained FDA Fast Track designation two days later. The position report stops before that news.
Telix's 30 September release concerns gallium-68 PSMA-PET imaging alongside MRI before a prostate biopsy. This proposed use remains investigational and has no FDA or other regulatory approval. 2
Fast Track can mean more frequent FDA contact and rolling review for programs addressing serious conditions and unmet needs. Other expedited pathways have their own eligibility criteria. The designation supplies no approval decision or commercial launch date. R3
BiPASS had already completed Phase 3 enrolment, disclosed in a 2 September ASX announcement filed with the SEC. The filing also describes FDA alignment on an NDA pathway. R4 Enrolment puts patients into the study; it does not supply a successful readout.
Telix says it plans an NDA submission through a new-product registration pathway. Approval of Illuccix and Gozellix for existing uses does not cover this pre-biopsy setting. 2 Study evidence, submission and the regulator's decision remain separate steps. Adoption and commercial returns would need evidence of their own.
ASIC's aggregate short reports arrive T+4. The quoted figure comes from its 28 September report. R5R1 It establishes neither a short seller's motive nor post-designation covering. The squeeze mechanics require more than a crowded position.
The chart is live; the quoted baseline remains 28 September. Any post-designation comparison needs later TLX position dates. The 10.75% print is the starting point.
Disclosure analysis, not medical guidance or an investment recommendation.