The Telix Pharmaceuticals Ltd (ASX: TLX) share price has jumped by 16.02% today on the back of a market announcement released this morning. The announcement confirmed the company has received a 'Breakthrough Therapy' (BT) designation for its renal cancer imaging product from the US Food and Drug Administration (FDA).
What does this mean for Telix?
The BT designation means that the FDA will work closely with Telix to provide guidance on the development of its product TLX250-CDx. The product is being developed to determine if "indeterminate renal masses" identified in MRI or CT imaging are either clear cell renal cell cancer or non-clear cell renal cell cancer. It does this using positron emission tomography imaging, which is an imaging technique that uses radioactive substances to visualise and measure metabolic processes in the body.
According to the announcement, the new BT designation offers Telix a number of significant benefits. These include eligibility for FDA's 'Fast Track' designation and more frequent and intensive interactions with the FDA. It also gives the company the opportunity to submit a 'rolling' biological licence application for the product, which allows it to submit its application in separate modules to streamline the approval process.
In order to achieve BT designation, Telix needed to provide preliminary clinical evidence that demonstrated its product could have substantial improvement on at least one clinically significant endpoint over available care. This means that the Telix product has shown positive results.
Commenting on the news, Telix CEO Dr Christian Behrenbruch said:
The granting of breakthrough designation by the FDA for our kidney cancer imaging product provides Telix with the opportunity to interact closely with the FDA to expedite the registration process of TLX250CDx, a particularly important consideration given the current Phase III development status of the asset. There is a significant unmet medical need to improve diagnosis and staging of clear cell renal carcinoma (ccRCC), which is the most common and aggressive form of kidney cancer. It's encouraging that the agency recognizes this.
About the Telix Pharmaceuticals share price
Telix is a biopharmaceutical company with a focus on molecularly targeted radiation. It is developing clinical-stage oncology products that will aim to address unmet medical needs in renal, prostate and brain cancer. The company is based in Melbourne and also has operations in Belgium, Japan and the United States.
In April, Telix released its Q3 FY2020 results and the company appears to be in healthy shape. It had cash reserves as at 31 March 2020 of $34.49 million, and invested $10.61 million during the quarter in direct R&D activities. Telix also spent around $4 million on one-off costs during Q3. These costs were related to making a drug product for its prostate and kidney cancer therapies.
The company received cash from sales of $1.14 million in Q3 FY2020, which was a 15% increase on the previous quarter.
During and subsequent to Q1 2020, Telix saw a number of achievements including:
- Gaining permission to trial TLX250-CDx in the US
- Acquisition of a licensed radiopharmaceutical production facility in Belgium
- A commercial agreement with Cardinal Health as a commercial partner in the United States.
The Telix share price is up 96% from its 52-week low of $0.755 cents. It has dropped 3% since the beginning of the year, however, the Telix share price is up 17% since this time last year.
