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The Clinuvel Pharmaceuticals share price is up 236% in 12 months

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price was an impressive performer on Monday.

The biopharmaceutical company’s shares raced to an all-time high of $36.98 before finishing the day 7% higher at $36.49.

When Clinuvel’s shares hit the $36.98 mark, it meant they had gained a staggering 236% since this time last year.

Why is the Clinuvel Pharmaceuticals share price on fire?

This latest gain appears to have been driven by the company’s recent inclusion in the benchmark S&P/ASX 200 index at the June quarterly rebalance.

It was added to the index after meeting the ranking requirements for the S&P/ASX 200 based on its float-adjusted market capitalisation and median liquidity over the past six months.

But the key driver of its share price gain over the last 12 months has been the success of its SCENESSE product.

SCENESSE has been developed as a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP).

A few years ago management made the strategic decision to self-distribute SCENESSE. Together with its decision to oversee and manage the supply chain and build a network of accredited centres of porphyria expertise, this has underpinned the company’s impressive sales growth.

During the March quarter the company reported cash receipts of $5.9 million, which was an increase of 126% on the previous quarter and 70% on the prior corresponding period.

And this does not include sales in the United States as SCENESSE is not yet available in this key market. But if all goes to plan, the company could be generating sales in the United States in the near future.

The US FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 6 to provide it with time for a full review of the submission of the SCENESSE scientific dossier. If the regulatory body gives SCENESSE the tick of approval, it could lead to a solid increase in sales.

Time will tell whether it is the next CSL Limited (ASX: CSL), but Clinuvel certainly is worth watching closely.

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Motley Fool contributor James Mickleboro 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.