ANGLE shares surge 58% after gaining US regulatory approval
After six long years of gathering data and evidence ANGLE’s (AGL:AIM) liquid biopsy platform Parsortix was given regulatory approval from the US Federal Drug Administration for use in the detection of metastatic breast cancer.
Although it has been a long wait for investors FDA approval is a significant milestone for ANGLE and has the potential to unlock a multi-billion market opportunity.
FDA approval de-risks uncertainty priced into the shares which surged 58% on the day of the announcement (25 May).
Taking tissue biopsies is expensive and bears the risks of side-effects and often the type of cancer is misdiagnosed.
The parsortix system extracts circulating cancer cells from a simple blood sample, reducing the cost, complexity, and risks of diagnosing cancers.
Berenberg’s analysts believe validation of the technology will increase the number of clinical studies into different cancers as well as accelerate the company’s pharmaceutical services franchise. Here, cancer cells are extracted to gain insights in drug trials.
Demonstrating the momentum, ANGLE announced (30 May) it has signed a clinical study agreement with Solaris Health, the largest US urology network comprising 179 clinics.
Berenberg said the high-profile deal should give ANGLE ‘significant commercial muscle’ to market the Parsortix system for prostate cancer.
The investment bank estimates prostate cancer is ANGLE’s largest addressable market worth around $5 billion in the US alone.