Cyclopharm Limited (ASX: CYC) shares are taking an absolute pummelling today. At the time of writing, the Cyclopharm share price is crashing 41.61% lower to $1.60.
Below, we take a look at the ASX healthcare company's latest market update.
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What did Cyclopharm announce?
The Cyclopharm share price is crumbling after the company reported on the latest developments regarding approval of its Technegas medical imaging drug in the United States.
The radiopharmaceutical company said the United States Food and Drug Administration (FDA) had provided a Complete Response Letter (CRL) for its New Drug Application (NDA).
In that response, the FDA said it could not approve the NDA for Technegas as it stands. The agency gave Cyclopharm a list of items it needs to address within 12 months to potentially gain approval. The company stated it expects to be able to sort out the required issues and hopes to still secure approval in 2022.
Commenting on the FDA response, James McBrayer, Cyclopharm CEO said:
While the elements in the USFDA's CLR letter are attainable within the required timeframe, we are disappointed with this news of the additional technical information requests. Effectively the CLR has extended the expected approval timeframe by around nine months.
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.
McBrayer said Cyclopharm is working closely with the FDA in order to address the outstanding elements still required.
The company updated its guidance for gaining FDA approval from the second half of 2021 to the second half of 2022. It said this delay will not influence its ability to fund the rest of the approval process. The US is a core part of the company's growth plans, which it estimates to be worth US$180 million (AU$237 million) per year.
Cyclopharm already sells Technegas in 60 other nations, with over 4.4 million patients using the medical imaging drug so far.
Cyclopharm share price snapshot
With today's early losses factored in, Cyclopharm shares have only gained around 19% over the past 12 months, compared to the 25% gains posted by the All Ordinaries Index (ASX: XAO).
Year to date, the Cyclopharm share price is now down by 36%.
