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CLINUVEL's company releases, including archives.

CLINUVEL TO SUBMIT EUROPEAN POST-MARKETING DATA AS PART OF NDA FOR EPPMelbourne, Australia and Leatherhead, UK, 19 September 2017 EUROPEAN POST-MARKETING SAFETY DATA TO BE SUBMITTED AS PART OF NEW DRUG APPLICATION (NDA), EXPECTED IN DECEMBER 2017 NO RISK EVALUATION & MITIGATION STRATEGIES (REMS) EXPECTED BUT A SIMILAR POST-MARKETING PROGRAM AS IN EUROPE FDA ANSWER IS EXPECTED TO THE REQUEST FOR PRIORITY REVIEW FAST TRACK = ROLLING REVIEW CLINUVEL PHARMACEUTICALS LTD [ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION: CLVLY; XETRA-DAX: UR9] today announced an update on its submission of the New Drug Application (NDA) for CLINUVEL’s drug SCENESSE® (afamelanotide 16 mg) to…
Wednesday, 06 September 2017 17:37

Appendix 3B Featured

Wednesday, 09 August 2017 07:51

Form 604, 09 August 2017

Monday, 31 July 2017 16:51

Appendix 4C - Quarterly report

Melbourne, Australia, and Leatherhead, UK, 31 July 2017 The Appendix 4C lodged earlier today reported in item 4.2 a “Net cash from / (used in) operating activities” result of (4,626) for the current quarter. This number should read 4,626, as referred to in item 1.9. Furthermore, item 4.5 “Effect of movement in exchange rates on cash held” should read 375 for the current quarter, instead of (375). This has now been corrected and reflected in the Appendix 4C attached. - End -CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing…
Wednesday, 10 May 2017 17:01

Appendix 3B

Wednesday, 10 May 2017 16:56

CLINUVEL Newsletter - May 2017

Tuesday, 02 May 2017 16:54

NICE ENGLAND UPDATE ON SCENESSE®

Melbourne, Australia and Leatherhead, UK, 2 May 2017 CLINUVEL PHARMACEUTICALS LIMITED (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the Department of Health (DoH) has designated SCENESSE® (afamelanotide 16mg) to be evaluated as a Highly Specialised Technology (HST). The re-classification acknowledges that the National Institute for Health and Care Excellence (NICE) committed an error in its earlier assessment of SCENESSE® as only eligible for review under a Single Technology Appraisal (STA), a mainstream appraisal pathway. The HST referral has been accepted by the UK Secretary of State for Health for the treatment of adult patients with the rare genetic…
Friday, 28 April 2017 17:21

Appendix 4C - Quarterly report

Melbourne, Australia, and Leatherhead, UK, 28 April 2017CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders announced today its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2017.The cash balance as at 31 March 2017 was $18,772,000, a decrease of $788,000 from the end of the previous quarter.Cash receipts for the quarter were $1,597,000 compared to $4,352,000 for the previous quarter. The expected decrease in receipts reflects the seasonal supply cycles of…
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