CLINUVEL PHARMACEUTICALS WKN: A0JEGY ISIN: AU000000CUV3 Forum: Aktien Thema: Hauptdiskussion

Australian TGA approves SCENESSE https://www.clinuvel.com/investors-area/news-2/media-release-tga-approves-scenesse Executive summary • SCENESSE approved by Australian TGA under Priority Review • First approved therapy for erythropoietic protoporphyria (EPP) in Australia • SCENESSE indicated for the prevention of phototoxicity in adult EPP patients, to be administered every two months • Follow up of patients as part of CLINUVEL’s commitment ... https://www.clinuvel.com/wp-content/uploads/2020/10/Media-Release-TGA-approves-SCENESSE%C2%AE.pdf https://www.clinuvel.com/wp-content/uploads/2020/10/Australian-TGA-approves-SCENESSE%C2%AE.pdf

Uiuiui gscheid verschrieben 😅

😀

Stimmt Australien und Japan waren ja in der zeottabelle ziemlich ma dran

Morgen wissen wir hoffentlich mehr. Ich glaube eine Zulassung oder einrichtung von Scenesse in UK, Frankreich, China oder Australien. 🤔

Aber dafür gab es ja bislang auch nie einen Handelsstopp... müsste ja was größeres sein bei dem CUV eine größere Schwankung im Kurs erwartet und daher den Stopp veranlasst hat

Vlt bringen die schon die Zahlen 😅 weil der 31. Ist ein Samstag und der steht noch im Kalender drin 😅

Ah ok danke

Ne Napf2 die Meldung kam nach der des xp Updates... zumindest gemäß hp Zulassung könnte ggf. sein

Oder es war das xp Update

Vielleicht neues Land mit EPP Zulassung UK?

Jmd ne Idee was da veröffentlicht werden könnte? Bei Trading Stopp hab ich bisher selten positive Entwicklung gesehen, hoffe das wird dies mal und va bei cuv anders laufen ... bin gespannt

https://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=02298783 https://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=02298574

Positives zu XP _________________________________________________________________________________________________________________________________ Melbourne, Australia, 26 October 2020 CLINUVEL PHARMACEUTICALS LTD provided today a clinical update on the use of its drug SCENESSE® (afamelanotide 16mg) in the first xeroderma pigmentosum (XP-C) patient receiving treatment as part of the Company’s DNA Repair Program.1 Ongoing safety assessment The first male XP-C patient started SCENESSE® treatment in September under a Special Access Program and has been closely monitored by the expert clinical centre responsible for medical care. Regular clinical observations have been made over the 42-day treatment period to assess the patient’s health, including the response to overall afamelanotide treatment. The patient tolerated the melanocortin drug well and no drug related adverse events have been reported. Specific attention has been given to the consequences of ultraviolet (UV) exposure, pigmentation, and overall status of the patient’s skin. XP patients are known to exhibit poikiloderma (degeneration and disintegration of the skin) and are prone to frequent bleeding from chronic wounds. At the end of the 42 days, the integrity of the skin of the XP-C patient has shown to be unaffected by afamelanotide. Commentary “We are delighted with the consistent safety reports from the XP-C patient receiving systemic treatment with afamelanotide,” CLINUVEL’s Clinical Operations Manager, Dr Pilar Bilbao said.“This positive observation and clinical feedback from the treating physician form the basis for progressing the planned XP study, CUV150.” Xeroderma Pigmentosum (XP) & DNA repair XP patients exhibit extreme deficiency in repair of UV-provoked damage to the DNA helix within the nucleus of skin cells. If left unrepaired, damaged DNA replicates and significantly increases the risk of skin cancers, including melanoma in these patients. XP-C is one of eight XP variants (XP-A to G, and V), reflecting different genes involved in the DNA repair process nucleotide excision repair (NER). Due to the inability to initiate or complete the NER process, XP patients are at approximately 10,000-fold risk of developing non-melanoma and melanoma skin cancers. Most XP patients will experience the first skin cancer before adolescence, while the leading cause of death remains progressive non-melanoma skin cancers and melanoma in the third decade. Due to the extreme rate of these malignancies, surgical intervention is frequently required, resulting in loss of extremities, facial anatomy such as ears, and eyesight. Scientific evidence supports the use of afamelanotide, the active ingredient in SCENESSE®, to protect skin from UV and light (systemic photoprotection), and repair UV-induced DNA damage. Further details of CLINUVEL’s DNA Repair Program will be provided in a Strategic Update, to be released this month.

Danke für das Feedback 👍🙏

50000 solltest schon im Depot haben, sonst sind es zu viel Positionen. Den Börsenbrief nachzubilden ist allerdings kaum möglich bzw. zu aufwendig. Ich selektiere da auch sehr stark und übergewichte Positionen die als langfristiger Invest gesehen werden, wie z.B. Clinuvel. Probier doch einfach mal ein Monat aus, dann merkst schon ob der Brief was für dich ist