Antisense Therapeutics WKN: 982306 ISIN: AU000000ANP4 Forum: Aktien Thema: Hauptdiskussion

ASX Announcement 15 February 2021 Antisense Therapeutics granted Type C meeting with US FDA for ATL1102 in DMD  Guidance meeting confirmed to discuss development of ATL1102 in the US Antisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY | FSE:AWY], (the Company) is pleased to advise that the US Food and Drug Administration (FDA) has granted a Type C guidance meeting scheduled for 19 April 2021 ET to discuss the further development of ATL1102 in Duchenne muscular dystrophy (DMD) in the US. The Company expects to provide an update in late May 2021 following receipt of the official minutes of the meeting. The Company with its US based expert regulatory consultants is clarifying via the meeting the preclinical requirements to support the clinical development of ATL1102 in the US in DMD patients and expect to conclude with guidance on the path forward. As part of its Type C meeting, the Company is requesting that the FDA consider allowing the data from previously conducted 6-month monkey toxicity studies, and recently obtained 6-month (24 weeks of dosing) clinical safety data in non-ambulant DMD patients, to support the longer term (12-month) dosing of ATL1102 in DMD patients in the US. Mark Diamond CEO of Antisense Therapeutics said: ”In parallel with our preparations for the conduct of the Phase IIb study in Europe planned to be launched in 2H’21, we look forward to our meeting with FDA to confirm the regulatory pathway for ATL1102 in DMD to bring this much needed new therapy to DMD patients in the US”. This announcement has been authorised for release by the Board. For more information please contact: Antisense Therapeutics Investment Enquiries Mark Diamond Gennadi Koutchin Managing Director XEC Partners +61 (0)3 9827 8999 gkoutchin@xecpartners.com.au www.antisense.com.au 1300 932 037 About Antisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY | FSE:AWY], is an Australian publicly listed biotechnology company, developing and commercializing antisense pharmaceuticals for large unmet markets in rare diseases. The products are in-licensed from Ionis Pharmaceuticals Inc. (NASDAQ: IONS), an established leader in antisense drug development. The Company is developing ATL1102, an antisense inhibitor of the CD49d receptor, for Duchenne muscular dystrophy (DMD) patients and recently reported highly promising Phase II trial results. ATL1102 has also successfully completed a Phase II efficacy and safety trial, significantly reducing the number of brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS). The Company has a second drug, ATL1103 designed to block GHr production that successfully reduced blood IGF-I levels in Phase II clinical trials in patients with the growth disorder acromegaly.

Leider kann ich hier kein Chart einfügen Aber alle relevanten Signale sind positiv -> kaufen siehe u.a. Wallstreet Online oder Ariva

1aud nehme ich sehr gerne

Man schätzt bis Ende des Jahres (lt. Ausstralischen Bord) ca. 1,00 A$, dass wären ca. 0,64 €. Ruft die Ausstralischen Links am besten im Smartphone auf, dort wird der englische Text in deutsch übersetzt (macht Google automatisch)

siehe auch https://www.wallstreet-online.de/diskussion/1308085-761-770/anp-ax-mkap-11-m-dmd-p2-daten-q4-mega-zock

Der Kurs wird jetzt anziehen, ich schätze mal bis 0,20 €.

Läuft

👍

So, dass waren meine Links als Erstinfo Gruss f_moll

https://www.sharecafe.com.au/2021/01/14/antisense-therapeutics-price-target-raised-from-0-305-to-0-43/

https://www.greenleiter.com/post/antisense-shares-have-increased-by-60-after-sarepta-results

https://hotcopper.com.au/threads/sarepta-gene-therapy-study-missed-key-target-in-duchennes.5848715/page-4

https://www.pressebox.de/inaktiv/dgwa-gmbh/DGWA-Portfolio-Performance-2020-113/boxid/1040792

https://***.be/l-lFcZ-YZj8

https://hotcopper.com.au/threads/ann-quarterly-update-and-appendix-4c.5874617/?direction=previous

Danke ;)