The Telix Pharmaceuticals Ltd (ASX: TLX) share price is edging lower on Thursday morning despite the release of a positive announcement.
At the time of writing, the biopharmaceuticals company's shares are down slightly to $5.61.
What did Telix announce?
The Telix share price is lower today despite providing an update on its U.S. Food and Drug Administration new drug application (NDA) review for its Illuccix product.
Illuccix is Telix's lead investigational product for prostate cancer imaging, which is a market management estimates to be worth US$900 million.
According to the release, the company has participated in a late-cycle review meeting with the FDA regarding the ongoing review of the NDA for the prostate cancer imaging investigational product.
Positively, during the meeting, the FDA indicated that there are no outstanding substantive review issues with Telix's submission.
Management commentary
Telix's Chief Executive Officer, Dr. Christian Behrenbruch, was pleased with the news.
He commented: "The late-cycle review meeting with the FDA continued a series of productive meetings with the Agency and sets the stage for the concluding phase of the NDA review process, including alignment on the final Illuccix product label."
Dr. Behrenbruch revealed that the company is now preparing itself for a potential launch if it gains approval.
"We remain optimistic about a positive outcome and, accordingly, are working closely with our commercial partners to prepare for the U.S. launch of Telix's lead product for prostate cancer imaging, pending approval. Delivering patient access to this important technology to support the management of prostate cancer remains a major corporate objective for Telix," he added.
The Telix share price has been a very strong performer over the last 12 months. Despite today's weakness, the Telix share price is now up a massive 325% since this time last year.
