Pinned straw:
Radiopharma company $TLX issued their quarterly report yesterday.
There were 2 significant disclosures in the report:
1) Zircaix update on expected resubmission date
2) Strong sales growth in Precision Medicine (PM)
TLDR: a positive report.
1. Zircaix Resubmission Update
When Zircaix was rejected last year by the FDA, CEO Christian indicated he expected the delay would be "less than one year". However, since that time the company has not given further indications on the timeline. The announcement today of "targeting a H1 submission" (i.e., within the next 2-3 months) indicates that they are well advanced in developing the resubmission package and that the two type A meetings with the FDA have proceeded in line with the initial expectations.
Here's the full relevant text.
"Based on two successful Type A meetings with the FDA, Telix believes it has aligned on key outstanding issues for the Biologics License Application (BLA) resubmission, including demonstration of drug product comparability between clinical trial material and scale-up commercial production. The Company is now completing the agreed deliverables and documentation required, targeting a H1 submission."
As someone who used to manage pharmaceutical manufacturing operations, I can say that a potential question-mark over the comparability between material used in clinical trials from that in commercial operations might have been a BIG issue. For the company to issue a statement such as shown above, indicates to me that they must be confident based on their FDA discussions that they have the necessary data package. Importantly, this issue does not relate directly to to safety or efficacy of the product. It could have been a big problem, but it seems to me that now will not be. That's positive for the outlook for Zircaix approval, IMHO.
2. Precision Medicine Revenues (all figures below $US)
The q-on-q incremental sales represents one of the strongest upticks in recent years. I've plotted this in the graph below.
The blue line (plotted on the LH scale) shows quarterly PM revenues. The orange bars plotted on the RH scale show the incremental quarterly revenues.
Two things stand out.
First, 1Q is seasonally a strong month (2024, 2025, and 2026).
However, the 2026 result stands out materially higher than this seasonal variability.
This indicates that after two years of maturing Illuccix sales (market penetration, competition, pricing pressure in the US) the combined impacts of the global rollout of Illuccix and initial contributions from Gosellix, are starting to reaccelerate revenue growth.
It will be interesting to see how this unfolds in the coming quarters.
Overall revenue of $230m in the quarter represents an annualised run-rate of $920m, getting close to the lower bound of annual guidance of $950-970m, which was reaffirmed.
A good result.
Final Comments
Overall, this is a pretty positive report. Across the rest of the development portfolio there appears to have been steady progress. (I'll not repeat the major developments which have been covered in previous straws and announced separately.)
Disc: Held
And as expected, the FDA has accepted $TLX's resubmission of the NDA for Pixclara (announced 4 weeks ago), and has put it on a 5-month timeline to review from today, and 6-months from the submission date.
Further details
$TLX announced that the U.S. FDA has accepted its resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara), a PET imaging agent for glioma, and assigned a PDUFA goal date of 11 September 2026. This represents a key regulatory milestone following the company’s March 2026 resubmission and reflects ongoing engagement with the FDA. The product has previously received Orphan Drug and Fast Track designations, highlighting both the seriousness of the condition and the potential for expedited review.
TLX101-Px is intended to address a significant unmet need in distinguishing tumour progression from treatment related changes in glioma patients, a challenge that remains central to clinical decision making. The imaging modality is already supported by international clinical guidelines, and clinicians cited in the release emphasised its importance in improving diagnostic accuracy and patient management.
TLX101-Px complements Telix’s therapeutic candidate TLX101-Tx, with the imaging agent potentially supporting patient selection and treatment monitoring. TLX101-Tx (iodofalan I-131) is currently in a pivotal Phase 3 trial, specifically the IPAX-BrIGHT study in patients with recurrent glioblastoma.
Despite the regulatory progress, Telix confirmed that FY26 guidance does not include any revenue contribution from the product, indicating that commercialisation remains contingent on approval.
My Assessment
While marked price-sensitive and, receiving a +5%SP response on a risk-off day, I saw this acceptance as almost 100% certain, given the reported feedback from FDA engagement and the nature of the gaps in the original submission. 11th September the key date to watch. Given the unmet clinical need, should approval be achieved in September, it would be reasonable to expect early decisions on US reimbursement, so there is a reasonable chance that Pxclara could start to contribute significantly to 2H FY27 revenue.
Disc: Held
Thanks for the update and summary of $TLX quarterly report @mikebrisy!!
I've been hoping this might materialise ( not that they have FDA approval just yet) and have patiently hung on IRL portfolio since early August last year. It's still down significantly, but I can see light at the end of that long tunnel, so happy to sit quietly on both my IRL and SM holdings for the foreseeable future.