The Telix Pharmaceuticals Ltd (ASX: TLX) share price is trading lower at open today, despite a positive development in its lead drug candidate. Telix announced that the United States Food and Drug Administration (FDA) will begin reviewing its new drug application (NDA) for TLX591-CDx.
At the time of writing, the Telix share price has dipped 0.8% to $3.72.
Telix advised the market today that the US FDA has deemed that the company’s NDA for TLX591-CDx is sufficient, and will begin a formal review.
During the standard review process, the FDA will conduct a mid-cycle review meeting date with Telix. This engagement seeks to discuss the status of the drug, key findings, and any issues that are identified. Telix revealed that the meeting will take place on 16 February 2021.
In addition, a label review date with the FDA will follow, with the date set on 30 May 2021. In the meeting, a team of technical experts will look to verify that the correct labelling meets FDA regulations.
Telix also said the FDA has provided intermediate milestones for the review process, and that no major issues have been found so far. In light of this, the FDA does not plan to hold an advisory committee meeting to discuss the application.
While Telix progresses with the FDA, the company is also focusing its efforts in the European Union, Canada and Australia. Telix advised it is moving along with its marketing authorisation application which has been submitted to authorities.
What did management say?
Telix CEO Dr Christian Behrenbruch welcomed the progress, saying:
With proximal review timelines for our NDA submission and considering the recent limited approval of Ga-PSMA for both imaging of high risk men prior to prostatectomy and biochemical recurrence, we feel our package is in a strong position to complete review in a timely fashion.
Telix’s kit-based formulation of Ga-PSMA is a game changer in terms of delivering access to this important technology and we look forward to working with the FDA to conclude the technical and clinical review of our submission during 2021.
About the Telix share price
The Telix share price has been storming higher lately due to a raft of announcements from the company. In just over a month, its shares have lifted more than 70%.
The Telix share price reached an all-time high of $4.33 this month, and finished the day yesterday at $3.75.
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Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.
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