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Why the Clinuvel Pharmaceuticals share price crashed 11% lower today

One of the worst performers on the local share market on Monday has been the Clinuvel Pharmaceuticals Limited (ASX: CUV) share price.

In morning trade the pharmaceutical company’s shares fell as much as 11.5% to $30.50.

Why did the Clinuvel share price crash lower today?

Investors were quick to hit the sell button this morning after Clinuvel provided an update on the Prescription Drug User Fee Act (PDUFA) goal date for its SCENESSE product.

According to the release, the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a new PDUFA goal date of October 6 2019.

Originally the FDA had set July 8 as its goal date but extended it by three months in order to provide it with more time for a full review of the submission of the SCENESSE scientific dossier.

Investors may be disappointed that this has delayed the potential sales of its lead compound in the lucrative market by a further three months.

The company’s chief scientific officer, Dr Dennis Wright, appeared to be disappointed by the delay.

He said: “It is not unusual to see the FDA extend its own timelines when it finds that it requires more time for review and to arrive at a final benefit-risk assessment. It is most frustrating that, while SCENESSE is being prescribed in the European Union and Switzerland and some of the US patients travel to Europe to obtain the treatment, the majority of US EPP patients have no access.”

He concluded: “We will continue to work with the FDA to work at all possible hours to assist the FDA staff to reach a positive conclusion on the scientific review of SCENESSE. We are sympathetic to the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September.”


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

Demand for the product has been growing strongly and led to the company posting a 126% quarter on quarter increase in cash receipts to $5.9 million during the March quarter.

Not all shares are sinking lower in the healthcare sector today. Both the Medical Developments International Ltd (ASX: MVP) share price and the Starpharma Holdings Limited (ASX: SPL) share price have charged higher after the release of positive announcements.

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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 Starpharma Holdings Limited. The Motley Fool Australia has recommended Medical Developments International Limited and Starpharma Holdings Limited. 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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