In the recently released quarterly results, Clinuvel Pharmaceuticals Limited (ASX: CUV) confirmed the steady growth in clinical demand for SCENESSE® in erythropoietic protoporphyria (EPP) which is a rare genetic metabolic disorder. The Cash receipts from customers in the September quarter increased by 89% to $10.7 million as compared to the same quarter last year. The cash balance at the end of September quarter was $44.39 million. Further, the net operating payments for the September quarter decreased by 12% to $2,864,000 compared to the same quarter of last year mainly due to the planning and management of key expenditures. As on 5 November 2018, Clinuvel Pharmaceuticals Shares uplifted by 8.597 percent.
In FY 2018, the board declared a first-time unfranked dividend of A$0.02 per ordinary share which was paid on 8 October 2018 to its shareholders who registered on 24 September 2018 record date. To answer the questions raised by some US physicians and patients about the timelines and availability of SCENESSE® in North America, the company reported about the frequent interaction with the US Food and Drug Administration (FDA) in its recently released News Letter. As per the company’s newsletter, in March 2016, the company’s teams were asked by the FDA to submit all clinical trial results individually and in a pooled format for a first global review to take place. In July 2016, FDA granted the company Fast Track Designation providing its teams the ability to submit the scientific dossier on a rolling basis. The FDA further conducted a Scientific Workshop on EPP in October 2016 and invited 150 US EPP patients and families as well as international expert academics in porphyria.
The company’s scientific teams had anticipated that, during the commercial distribution of SCENESSE® in Europe, more safety and effectiveness data would become available which is why they requested the FDA to allow its incorporation into the dossier to increase the information on the product under real-world conditions. FDA is known to scrutinize innovative technologies to ensure that all aspects of manufacturing are controlled, and no surprises manifest once the product is commercially available in the US. It is in this context that the FDA shoulders joint responsibility with the pharmaceutical sponsor for the new commercial product when American citizens are exposed. The Company is waiting for the FDA’s decision on its own formal review process, either a Standard Review or an accelerated process under a Priority Review.
The company also reported about the interchange with the advisory body National Institute for Health and Care Excellence (NICE) which has a decisive role in recommending therapies for reimbursement by the English National Health Service England (NHS England). Recently, the company also announced about the expansion of its research and development facilities in Singapore.
In the last six months, the share price of the company increased by 50.34 percent as on 2 November 2018. CUV’s shares traded at $19.200 with a market capitalization of circa $846.13 Mn as on 5 November 2018 (AEST 4:00 PM).
The advice given by Kalkine Pty Ltd and provided on this website is general information only and it does not take into account your investment objectives, financial situation or needs. You should therefore consider whether the advice is appropriate to your investment objectives, financial situation and needs before acting upon it. You should seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) as necessary before acting on any advice. Not all investments are appropriate for all people. Kalkinemedia.com and associated websites are published by Kalkine Pty Ltd ABN 34 154 808 312 (Australian Financial Services License Number 425376). website), employees and/or associates of Kalkine Pty Ltd do not hold positions in any of the stocks covered on the website. These stocks can change any time and readers of the reports should not consider these stocks as advice or recommendations.