- In a day of losses on the ASX 200, Clinuvel’s share price has remained strong
- The company announced a U.S. Food and Drug Administration review of its SCENESSE’s scientific dossier product has been slightly delayed
- SCENESSE is designed to treat people with erythropoietic protoporphyria — a condition which makes skin hyper-sensitive to the sun
- Clinuvel’s share price is up 4.07 per cent today, currently sitting at $25.80 apiece
Clinuvel shareholders are undeterred by a minor setback in receiving a U.S. Food and Drug Administration (FDA) review of the company’s SCENESSE product.
Going against today’s odds, which has seen over 80 per cent of ASX 200 companies in the red, Clinuvel has added over one dollar to its share price, recording a four per cent boost.
The pharmaceutical company’s SCENESSE is designed to assist people who have erythropoietic protoporphyria: a condition which leaves skin hyper-sensitive to the sun, causing pain or burning.
Clinuvel was firstly advised by the FDA its review date for SCENESSE’s scientific dossier under the Prescription Drug User Fee Act was set for October 6. Due to a miscommunication, the date is now set for October 8.
“Our team continues to engage with the FDA at this late stage to address final questions and clarifications on the dossier,” Clinuvel’s Chief Scientific Officer, Dr Dennis Wright, said.
“While it may be frustrating for all who take an active interest in our programs, nothing materially has changed in our outlook and we will continue our diligent approach in the coming days to seek a positive outcome,” Dr Dennis continued.
Shares in Clinuvel are currently trading at $25.80 apiece, as of 1:27 pm AEST.