Telix Pharmaceuticals’ stock is struggling on the ASX today. Here’s why.
The post Telix (ASX:TLX) share price sinks 6% on FDA update appeared first on The Motley Fool Australia. –
Illuccix is currently in the midst of the US Food and Drug Administration’s (FDA) approval process. However, Telix has announced the FDA has extended the product’s review period by 3 months.
The Telix share price has fallen 6.3% on the back of the news. Shares in the company are currently trading for $6.37 a piece.
Though, earlier today they hit a low of $5.66, representing a drop of 16%.
Let’s take a closer look at today’s news from the biotechnology company.
Illuccix’s FDA approvals process extended
The Telix share price is tumbling today after the company announced the FDA has extended its review process for Illuccix.
The date for the process to be finalised has now been pushed back to 23 December 2021.
The extra time will allow the FDA to further review and consider information to do with the product’s manufacturing, as well as conclude its label review.
According to Telix, 3 months is the FDA’s standard review extension period.
Telix noted that it had met with the FDA in June. Then, the FDA stated it wasn’t aware of any manufacturing or clinical review issues with Telix’s Illuccix.
However, Telix’s pre-authorisation inspection (PAI) fell after the review meeting and raised a set of manufacturing-related observations.
Illuccix is also under review by Australia’s Therapeutic Goods Administration and the company’s working towards marketing authorisation applications for Illuccix in Europe and Canada.
Telix share price snapshot
Despite today’s dip, the Telix share price has been performing well lately.
Right now, it is 58% higher than it was at the start of 2021. It has also gained 261% since this time last year.
The company has a market capitalisation of around $1.9 billion.
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Motley Fool contributor Brooke Cooper has no position in any of the stocks mentioned.
The Motley Fool Australia’s parent company Motley Fool Holdings Inc. 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.