- Cyclopharm (CYC) expects its Technegas product will receive United States Food and Drug Administration (FDA) approval in the first half of this year
- Technegas is a lung ventilation imagine agent which is used to assess a patient's lung function
- Cyclopharm has also been given a glimpse of its FY20 financial year results
- Despite a challenging first half, the company bounced back from COVID-19 with total revenue expected to be in line with FY19 at approximately $14 million
- On market close, Cyclopharm is up 6.78 per cent and is trading at $2.52 per share
Cyclopharm (CYC) has announced its Technegas product is on track to receive United States Food and Drug Administration (FDA) approval in the first half of 2021.
Technegas is the company's lung ventilation imaging agent. The product is taken by a patient during a medical imaging procedure so the images accurately demonstrate the lung function.
The company has seen strong support for Technegas in the U.S. from frontline healthcare workers.
Cyclopharm is on track with a pre-approval audit, saying it is scheduled for the week commencing March 29, 2021.
Due to COVID-19, the FDA put a pause on all onsite inspections and will use alternatives such as desk-top and virtual audits. However, Cyclopharm has now been informed the FDA will be conducting an onsite pre-approval audit at its manufacturing facility in Kingsgrove, New South Wales.
This onsite inspection will also happen on the last week of March.
The company has also released its unaudited management accounts for the full year ending December 31, 2020.
Even though it was a challenging year due to COVID-19, Cyclopharm had a rebound in the second half of the year with total revenue expected to be in line with FY19 at approximately $14 million.
Due to the introduction of improved patient processing procedures and the availability of personal protection equipment for health care workers, Technegas procedures came back strongly in the second half as revenue increased by 39.2 per cent to $5.1 million compared to the first half of the year.
Cyclopharm will update the market on its full year performance in February.
On market close, Cyclopharm is up 6.78 per cent and is trading at $2.52 per share.