Over the past 12 months, the Telix Pharmaceuticals Ltd (ASX: TLX) share price has posted massive gains exceeding 150%. The Telix share price kicked off 2020 at $1.53, closed the year at $3.78 and is currently sitting at $3.86 per share.
So what has Telix done to achieve this remarkable pump for its share price?
Significant US Food and Drug Administration (FDA) wins
In January 2020, Telix announced that the US Food and Drug Administration (FDA) approved the recruitment of American participants in the company's Zirconium Imaging in Renal Cancer Oncology (ZIRCON) study. This was an important milestone because it extended the Phase III study into new territory beyond Australia and Europe.
The purpose of the international study is to evaluate Telix's kidney cancer imaging agent (TLX250-CDx), which aims to detect the most common form of kidney cancer, clear cell renal cell carcinoma. The FDA followed this approval up by designating TLX250-CDx as a 'Breakthrough Therapy'.
In February 2020, Telix announced that the FDA had also offered positive feedback regarding the company's submission of a New Drug Application (NDA) for its product TLX591-CDx. TLX591-CDX is an imaging radiopharmaceutical to support people suffering from prostate cancer.
When Telix announced that the company had formally submitted the NDA in July 2020, the Telix share price jumped 16%. In the company's August 2020 half-year shareholder report, it was noted that sales of the TLX591-CDx kit were up 28% compared to the previous corresponding period (PCP). This resulted in a $2.1 million bump in cash receipts.
Telix continued marching forward with yet another FDA approval last October regarding its 18F-FET product, which supports the imaging of glioma, a type of brain tumour.
The strategic acquisition of TheraPharm
As 2020 carried on, Telix diligently expanded its market reach. In November 2020, they announced that the company had entered an agreement with Scintec Diagnostics to acquire TheraPharm. TheraPharm is a Swiss-German biotechnology company developing diagnostic and therapeutic solutions in the field of haematology — specifically, blood cancers.
The acquisition was finalised in December 2020.
What's on the horizon for the Telix share price?
Telix continues to aggressively pursue opportunities for the company's suite of pharmaceutical products. On 16 December 2020, Telix filed a New Drug Submission (NDS) with Health Canada pertaining to TLX591-CDX product approval.
Later that month, Telix provided a clinical update regarding research connected to its TLX101 product in Australia and Europe. TLX101 endeavours to treat recurrent glioblastoma multiforme, a cancerous brain tumour.
A 12-month share price hike of 150% won't be an easy achievement to top. As we enter 2021, investors will no doubt be keeping an eye on Telix's pipeline to see if the company can keep up with last year's powerhouse performance.
