The Telix Pharmaceuticals Ltd (ASX: TLX) share price is trading slightly higher on Tuesday after the release of a positive update.
At the time of writing the clinical-stage biopharmaceutical company's shares are up 0.5% to $1.52. This compares favourably to a 1.4% decline by the S&P/ASX 200 index.
Today's small gain means that the Telix share price is up over 100% since this time last year.
What did Telix announce?
This morning the company announced that it has received positive feedback from the US Food and Drug Administration (FDA) regarding its submission of a New Drug Application (NDA) for TLX591-CDx. TLX591-CDx (illumet) is a radiopharmaceutical cold kit for the preparation of 68Ga-PSMA-11 injection.
This follows the submission of additional clinical data for its NDA submission that was submitted to the FDA following a pre-NDA meeting.
This data is based on a combination of prospective and retrospective data, including imaging data from the Novartis VISION study.
According to the release, the FDA has provided detailed feedback on the clinical briefing package for the efficacy data, which the company expects to be able to satisfy, based on the planned submission dataset.
Another positive is that the FDA has indicated that the safety dataset is adequate, subject to formal NDA review.
Telix's CEO, Dr Chris Behrenbruch, said: "We appreciated the opportunity to put our proposed clinical data to the Agency as a further refinement of our NDA submission plan. The feedback from the FDA was supportive of our approach, with useful analytical recommendations that will further strengthen our submission. In taking an extra two months to engage with the FDA, we further reduce the risk to the NDA submission process."
What's next?
The company advised that the timeline to submission of the complete NDA package, which will incorporate that additional FDA feedback and publishing, will be approximately 30 to 60 days.
Management advised that it has also amended its Drug Master File (DMF) to include manufacturing-related recommendations previously made by the FDA.
