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.

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Motley Fool contributor Cathryn Goh has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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In late morning trade the S&P/ASX 200 Index (ASX: XJO) looks set to end its positive run. Although it is off its lows, the benchmark index is still down 0.35% to 5,761.4 points.

Four shares that have fallen more than most today are listed below. Here’s why they are dropping lower:

The Afterpay Ltd (ASX: APT) share price is down 5% to $46.61. Investors appear to be taking profit off the table after some stellar gains over the last few weeks. On Tuesday the Afterpay share price broke through the $50.00 mark for the first time. This strong gain has been driven largely by its impressive sales and customer growth and the arrival of Tencent Holdings as a substantial shareholder. Tencent is the ~US$500 billion company behind the massive WeChat app.

The CSL Limited (ASX: CSL) share price has dropped 4.5% to $293.21. This is despite there being no news out of the biotherapeutics company. I suspect that investors are taking profit after its shares stormed higher in 2020. Prior to today, they were up approximately 12% year to date.

The Fortescue Metals Group Limited (ASX: FMG) share price has fallen over 3.5% to $13.26. Investors have been selling Fortescue’s shares today after a pullback in the iron ore price overnight. According to CommSec, iron ore fell by US$2.25 or 2.3% to US$94.60 a tonne after data showed that global steel production fell 13% in April.

The Newcrest Mining Limited (ASX: NCM) share price is sinking 4.5% lower to $30.42. Investors have been selling Newcrest and the rest of the gold miners after a pullback in the price of the precious metal. Overnight the spot gold price fell by almost 2% after demand for safe haven assets reduced. At the time of writing the S&P/ASX All Ordinaries Gold index is down a sizeable 5.4%.

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James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. owns shares of CSL Ltd. The Motley Fool Australia owns shares of AFTERPAY T FPO. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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In morning trade the S&P/ASX 200 Index (ASX: XJO) is on course to give back some of yesterday’s gains. At the time of writing the benchmark index is down 0.45% to 5,754.3 points.

Four shares that have not let that hold them back are listed below. Here’s why they are racing higher:

The ALS Ltd (ASX: ALQ) share price is up almost 2.5% to $7.21 after the release of its full year results. This morning the testing services company reported a 10% increase in revenue to $1,831.9 million and a 4.3% lift in underlying net profit to $188.8 million (both from continuing operations). The latter was in line with its guidance range. ALS was confident enough in its outlook and balance sheet to declare a final dividend of 6.1 cents per share.

The Metcash Limited (ASX: MTS) share price is up 2% to $2.69. This appears to have been driven by a broker note out of UBS this morning. According to the note, the broker has upgraded Metcash’s shares to a buy rating with a $2.85 price target. It likes Metcash because of the strength of the grocery channel and the improving outlook for the hardware channel.

The National Australia Bank Ltd (ASX: NAB) share price has jumped a further 5% to $17.47. The big four banks are on fire again on Wednesday. Investors continue to pile in on the belief that they were oversold during the pandemic. Especially given Australia’s quicker than expected reopening, which looks set to lessen the economic damage.

The Pointsbet Holdings Ltd (ASX: PBH) share price has stormed 8% higher to $5.48. Investors have been buying the sports betting company’s shares after the release of a trading update. That update revealed that its Australian business has achieved a net win of $18.2 million for the period 1 April to 25 May. This has been driven by a shift in gambling online following the closure of retail venues.

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James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. owns shares of Pointsbet Holdings Ltd. The Motley Fool Australia has recommended Pointsbet Holdings Ltd. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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