Join our daily newsletter At The Bell to receive exclusive market insights
- Cyclopharm (ASX:CYC) receives US FDA approval to commence commercial sales of its novel drug candidate, Technegas, in the US market
- Cyclopharm will provide and install Technegas generators in nuclear medicine departments to increase the adoption and use of single-patient consumables
- The approval lands CYC in the single largest market for Technegas worldwide, worth A$279.8 million annually for the diagnosis and management of pulmonary embolism
- The company will commence the rollout of the drug, which is planned for early November, once the final assembly of its first wave of 200 generators is finished
- CYC shares are up 5.12 per cent, trading at $2.98 at 3:59 pm AEDT
Cyclopharm (ASX:CYC) has received approval from the United States Food and Drug Administration (FDA) to commence commercial sales of its novel drug candidate, Technegas.
Cyclopharm will provide and install Technegas generators in nuclear medicine departments to boost the adoption and use of single-patient consumables.
The approval places CYC in the single largest market for Technegas worldwide, estimated to be worth approximately US$180 million (A$279.8 million) annually for the diagnosis and management of Pulmonary Embolism (PE).
The company plans to kick off the commercial rollout of the drug in early November, after completing the final assembly of its first wave of 200 generators.
“While FDA approval for Technegas is a major milestone for Cyclopharm, our ability to now make this technology available to US clinicians and to the patients they serve, is where the key significance lies,” CYC Managing Director James McBrayer said.
Cyclopharm will implement a planned marketing strategy to maximise sales and operational expertise across 64 countries globally where its product is already approved and established.
To date, the company has received 420 formal expressions of interest in the product from US clinicians and their representative bodies, which have lobbied heavily for Technegas’ approval.
CYC shares were up 5.12 per cent, trading at $2.98 at 3:59 pm AEDT.
