Join our daily newsletter At The Bell to receive exclusive market insights
- Cyclopharm (CYC) has provided an update on the new drug application (NDA) for its Technegas product
- Technegas is a lung ventilation imaging agent, which is used to assess a patient’s lung function
- At the end of this month, the U.S. Food and Drug Administration (FDA) will begin its pre-approval audit of Cyclopharm’s manufacturing facility
- Once this has been completed, the FDA will give Cyclopharm the product labelling requirements by early May
- The FDA’s goal date to complete the review of the NDA is June 26 2021 and once this has been officially approved, Cyclopharm can market Technegas across the U.S.
- Cyclopharm ended the day 9.24 per cent in the green with shares closing at $2.60
Cyclopharm (CYC) has provided an update on its new drug application (NDA) for its Technegas product.
Technegas is a lung ventilation imaging agent, which is used to assess a patient’s lung function.
The NDA was sent off to the U.S. Food and Drug Administration (FDA) and, if it’s approved, the company can market the product across the U.S.
At the end of the month, the FDA is expected to begin its pre-approval audit of Cyclopharm’s manufacturing facility. The company has reportedly been assisting the healthcare regulator with the audit by providing more information.
Once the pre-approval audit has been completed and the FDA reviews the relevant documents, it will provide Cyclopharm with the proposed labelling requirements for Technegas by early May.
The FDA’s goal date to complete the review of the NDA is June 26, 2021. Cyclopharm says this broadly aligns with its expectations and reaffirms its anticipation to commence sales early in the second half of the year.
Cyclopharm ended the day 9.24 per cent in the green with shares closing at $2.60.
