The Cyclopharm Limited (ASX: CYC) share price has rocketed out of the gates this morning after the company announced another milestone in its quest to gain approval in the lucrative US market.
After jumping as much as 21.83% higher in early trade, Cyclopharm shares have pulled back somewhat to currently sit 9.16% higher at $1.55 per share. This takes its market capitalisation at the time of writing to around $121 million.
About Cyclopharm
Cyclopharm is a radiopharmaceutical company primarily involved in the field of nuclear medicine. It operates in the diagnostic imaging field, specialising in lung health.
The company's core radiopharmaceutical product is Technegas, a structured ultra-fine dispersion of radioactive labelled carbon used in lung ventilation imaging.
Cyclopharm has a global presence, distributing its products in 57 countries throughout the world with more than 1,500 medicine departments utilising Technegas.
Why is the Cyclopharm share price rocketing?
This morning, Cyclopharm announced that it has been granted approval to file status for its new drug application (NDA) for Technegas.
As a result, Technegas will now proceed to the next stage of the US Food and Drug Administration (FDA) approval process – review. The review stage will involve a 10-month qualitative review where the FDA will assess "the safety and efficacy of Technegas as a nuclear medicine functional lung ventilation imaging agent"
The NDA approval announced today marks the 3rd milestone in the company's 7-step pathway to achieving FDA approval for Technegas.
Commenting on today's update, CEO James McBrayer said:
We are absolutely thrilled with the progress we are making in completing the steps to gain approval to market Technegas in the USA. This Approval to File follows our successful lodgment in March and a full USD $2.9m Fee Waiver designation in April. Today's notification confirms that we are on track for Technegas to be approved early next year.
As for Cyclopharm's total addressable market opportunity, Mr McBrayer stated:
The United States is the largest nuclear medicine market in the world. We estimate the size of the US market for Technegas in diagnosing the presence of Pulmonary Embolism (PE) is approximately US$90 million in sales per annum. Following USFDA approval to sell into that market, we will be targeting a 50% share of this market in the first 2 to 3 years, rising to 80% over 5 to 7 years.
The company also has plans to expand Technegas beyond PE into new applications, such as the diagnosis and monitoring of chronic obstructive pulmonary disease (COPD), asthma, and other respiratory diseases.
