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Cyclopharm (ASX:CYC) - Managing Director and CEO, James McBrayer (right)
Managing Director and CEO, James McBrayer (right)
Source: Finance News Network
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  • Radiopharmaceutical company Cyclopharm (CYC) has been approved by the U.S. Food and Drug Administration (FDA) to file a new drug application
  • The application is for the company’s proposed functional lung ventilation imaging agent, Technegas
  • With the company approved to file, the FDA will now have a 10-month period to assess the safety and efficacy of Technegas
  • If all approvals are met, Cyclopharm hopes to reach FDA approval by the second quarter of 2020
  • Cyclopharm is down 0.96 per cent on the market today, trading for $1.55 per share

Radiopharmaceutical company Cyclopharm (CYC) has been approved by the U.S. Food and Drug Administration (FDA) to file a new drug application.

The application is for the company’s proposed functional lung ventilation imaging agent, Technegas. 

The gas is inhaled by a patient during a medical imaging procedure. The company claims the resulting images allow medical professionals to accurately capture the lung functioning and help the diagnostic process.

Previously used to diagnose pulmonary embolisms, the company hopes to expand Technegas’s capabilities to help diagnose chronic obstructive pulmonary disease, asthma and pulmonary hypertension.

With the company approved to file, the FDA will now have a 10-month period to review the new drug application. During this time, the FDA will assess the safety and efficacy of Technegas

After the review process is complete, the FDA will complete a manufacturing site inspection, which is expected in the first quarter of next year. 

In preparation for full approval, Cyclopharm will begin increasing its inventory from the third quarter onwards. 

If all approvals are met, Cyclopharm hopes to reach FDA approval by the second quarter of 2020. 

Managing Director and CEO, James McBrayer is pleased the FDA process is moving along.

“We are absolutely thrilled with the progress we are making in completing the steps to gain approval to market Technegas in the U.S.

“This approval to file follows our successful lodgement in March and a full fee waiver designation in April. Today’s notification confirms that we are on track for Technegas to be approved early next year,” he said.

Cyclopharm is down 0.96 per cent on the market today, trading for $1.55 per share at 11:21 am AEST.

CYC by the numbers
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