The Telix Pharmaceuticals Ltd (ASX: TLX) share price is taking a tumble on Wednesday.
In morning trade, the therapeutic radiopharmaceuticals company's shares are down 12% to $4.74.
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Why is the Telix share price sinking?
Investors have been selling down the Telix share price on Wednesday following the release of a disappointing announcement relating to its European aspirations.
According to the release, the company has withdrawn its marketing authorisation application (MAA) in Europe for its investigational product Illuccix.
Management advised that during the late stages of review, the Danish Medicines Agency (DKMA), in consultation with other European regulatory authorities, requested additional Chemistry, Manufacturing and Control (CMC) data.
Unfortunately, as these requests cannot be reasonably delivered within the prescribed review timeframe, Telix elected to withdraw the application.
This has come as big surprise to both investors and the company. Telix highlights that it was "an unexpected and extremely disappointing result considering that Illuccix has been approved by other major global regulators."
It also highlights that the company has a "track record of delivering PSMA PET imaging reliably and safely to tens of thousands of European men with prostate cancer under compassionate and "magisterial" use availability."
What's next?
Telix intends to resubmit for a marketing authorisation for Illuccix in Europe. It is also assessing alternative regulatory options available for the most streamlined route to approval with a revised submission
Telix CEO, Dr Christian Behrenbruch, commented:
This is not the outcome we expected, despite our best efforts to meet all regulator information requests. The outcome is reflective of the novelty of our submission approach ('full mixed' application) and the specific nuances of European product approval requirements (EU Pharmacopoeia). We are confident that the additional data can be provided, but the prescribed timeframes of the review process mean that the most efficient process is to withdraw the application and then resubmit.
We note that the financial impact for FY2023 is minimal as full commercial sales were not expected to commence until mid-2023, following completion of the national approval phase and securing individual country reimbursement. We are in the fortunate position of having commercial sales underway in the United States and Australia, where we expect to see the growth trajectory continue. We remain committed to bringing an approved 68Ga-PSMA-11 product to market in Europe.
But it wasn't all bad news today. In a separate announcement, Telix revealed that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation has approved a pivotal Phase III registration study.
This study will bridge to Telix's global Phase III 'ZIRCON' trial of TLX250-CDx for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET).
