The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price has fallen more than 9% during trading today. CUV shares opened at $35.57 this morning but at the time of writing, the price has dropped to $32.99, a fall of around 8.49%.
The reasons for this drop are not entirely clear, although it may involve some profit taking. At today's open price, Clinuvel shares were up 97.6% YTD, and 62% over the last three months. These price gains were likely assisted by the company's inclusion in the S&P/ASX 200 (INDEXASX: XJO) index as of 24 June.
Today's drop may also involve a delayed reaction to Clinuvel's 'communiqué', which was released to the market yesterday before opening. Clinuvel provided an update on the pending US Food and Drug Administration review of its SCENESSE (afamelanotide) product, which has been extended by three months to 6 October 2019.
Clinuvel hopes that SCENESSE (if approved) will be useful in treating erythropoietic protoporphyria (EPP), of which (according to Clinuvel) there is little effective treatment currently available to US patients, many of whom travel to Europe for treatment.
In its release, the company stated: "although the extension… for three months is not our favoured outcome, we remind all stakeholders that if insurmountable outstanding scientific issues were identified during the filing stage, and/or major deficiencies were identified during their due diligence to date, the FDA has always been able to issue a Refusal to File (RTF) and/ or recommend a withdrawal of the NDA. Since these events had not occurred, we embrace a cautious optimism and bear the patience to a long-awaited outcome."
