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U.S. FDA targets mid-year approval for Cyclopharm’s (ASX:CYC) Technegas

Health Care
ASX:CYC      MCAP $151.1M
12 March 2021 14:40 (AEDT)
Cyclopharm (ASX:CYC) - Managing Director and CEO, James McBrayer

Source: Cyclopharm

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.

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