- Dimerix obtained the European Medicines Agency’s written response on its proposed Phase 3 study design for Focal Segmental Glomerulosclerosis (FSGS).
- Oncology player Telix Pharmaceuticals entered into a co-promotion agreement with Eckert & Ziegler in the US.
- Pro Medicus revealed that its US subsidiary, Visage Imaging, entered a multi-year research agreement with Mayo Clinic.
ASX 200 ended 0.59% higher today, gaining 43.30 points to hit a new 100-day high. Three Australian healthcare shares - Dimerix Limited (ASX:DXB), Telix Pharmaceuticals Limited (ASX:TLX) and Pro Medicus Limited (ASX:PME) – were trending today and saw considerable movement in their share price today.
Let us now have a closer look at why DXB, TLX and PME were in the spotlight today-
Dimerix obtains EMA’s confirmation for DMX-200 Phase 3 study
Clinical-stage biopharmaceutical player Dimerix Limited confirmed that the European Medicines Agency (EMA) had given a written response on the proposed Phase 3 study design for Focal Segmental Glomerulosclerosis (FSGS).
The Company disclosed that EMA reviewed a dossier that summarised the proposed Phase 3 clinical trial of Dimerix for FSGS and its non-clinical studies data, manufacturing and process controls as well as all existing Phase 1 and Phase 2 clinical data.
DMX-200 has secured Orphan Drug Designation (ODD) in the US and Europe for the treatment of FSGS. Phase 3 clinical study initiation is planned for early Q3-2021. The Phase 3 protocol proposal is also under review by the US Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA).
Dimerix notified that the EMA had also confirmed the proposed non-clinical package and that the drug manufacturing method of DMX-200 was suitable to support its marketing authorisation application (MAA) in Europe.
DXB shares last traded at AU$0.230, in line with the previous close.
Telix enters in US Co-Promotion Agreement with Eckert & Ziegler
Oncology player Telix Pharmaceuticals announced that the Company has entered into a co-promotion agreement with Berlin-based Eckert & Ziegler Strahlen und Medizintechnik AG (EZAG) in the US. The deal is for the combination of EZAG’s GalliaPharm® (gallium-68 generator) and Telix’s investigational prostate cancer imaging product, Illuccix®. Illuccix® is a kit that is used for the preparation of 68Ga-PSMA-11 injection.
Under the terms of the agreement, Telix and EZAG will expand their existing collaboration to further develop access to Ga-68 supply in the US. In addition, both the parties will co-promote Illuccix® and GalliaPharm® to make sure that the healthcare providers across the nation have secure access to Illuccix® and Ga-68 generators.
Telix Americas President, Dr Bernard Lambert, stated-
Currently, Illuccix®’s New Drug Application (NDA) is under review by the US FDA and includes support for GalliaPharm®.
TLX shares closed at AU$4.340, down by 2.472%.
PME enters in multi-year research agreement with Mayo Clinic
Leading health imaging firm Pro Medicus updated the market that its wholly-owned US subsidiary, Visage Imaging Inc, entered a multi-year research collaboration agreement with Mayo Clinic.
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The Company disclosed that this agreement would serve as the framework for collaboration between the two parties to facilitate artificial intelligence (AI) research and development. Moreover, with this agreement, Mayo Clinic will leverage the capabilities of the Visage AI Accelerator platform.
Pro Medicus also revealed that the new collaboration agreement builds on the existing Mayo Clinic Visage 7 Viewer agreement.
PME shares ended the day’s session at AU$47.6100, up by 3.163%.