- Cyclopharm (CYC) shares drop 35 per cent after the US Food and Drug Administration knocked back its drug application for Technegas
- The healthcare stock revealed on Monday the FDA has been unable to approve its New Drug Application, while also providing a list of recommendations
- CYC’s Managing Director and CEO says the knock back is disappointing, but he’s confident the company can address the FDA’s requirements
- The healthcare stock is hopeful it can gain FDA approval of Technegas, which is designed to provides ventilation imaging, within another nine months
- Company shares remain trading in the red towards the close of market, down 35.8 per cent at $1.76, with 98 cents wiped from its price in today’s session
Cyclopharm (CYC) shares dropped 35 per cent after it announced the US Food and Drug Administration (FDA) knocked back its drug application for Technegas.
The healthcare stock revealed on Monday the US FDA had been unable to approve its New Drug Application, while also providing a list of recommendations.
Most of the issue outlined by the drug body involve better defining and validating
the unique characteristics and delivery of Technegas, which was designed to provides ventilation imaging.
Commenting on the FDA’s decision, CYC Managing Director and CEO James McBrayer said it was disappointing.
“While the elements in the US FDA’s CLR letter are attainable within the required timeframe, we are disappointed with this news of the additional technical information requests,” Mr McBrayer said.
“Effectively the CLR has extended the expected approval timeframe by around nine months.”
Mr McBrayer said the company was confident it could resolve the outstanding issues raised by the FDA within that time period.
“We have complete confidence that we can address these matters and do what is required to expedite this process.
“We now have clarity as to what will satisfy the USFDA’s expectations and will commence work on the response immediately.”
Despite the reassurance, following today’s news, shares in Cyclopharm have plummeted with 98 cents wiped from the company’s share price.
It closed last Friday’s trading session at $2.74, before dropping over 35 per cent during Monday’s session.
At the close of market, CYC’s share price was down 35.8 per cent at $1.76.