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BioWorld - Thursday, April 16, 2026
Home » Topics » Asia-Pacific » Australia

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Laptop displaying FDA logo

FDA issues refusal to file letter for Telix imaging agent

Aug. 1, 2024
By Tamra Sami
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
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The Nasdaq Stock Exchange headquarters in New York

Radiopharm Theranostics to list on Nasdaq by year-end

July 31, 2024
By Tamra Sami

Radiopharm Theranostics Ltd. said it plans to list on Nasdaq by the end of 2024. The company had earlier announced plans to list in February 2023, but it delayed the listing due to market conditions.


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Antibodies (light blue) and G protein-coupled receptors (purple)
Newco news

Alkira Bio exits stealth via seed round to develop GPCR-targeting antibodies

July 30, 2024
By Tamra Sami
Alkira Bio, a new spinout from Australia’s Florey Institute of Neuroscience and Mental Health has emerged from stealth mode thanks to seed funding from Curie.bio. Although the amount of funding is not disclosed, Curie.bio typically invests $5 million to $10 million in a founder company and then co-pilots the drug discovery program, deploying drug development experts to its portfolio companies to help navigate decision making as part of the deal, Florey researcher turned Alkira Bio CEO Daniel Scott told BioWorld.
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Antibodies (light blue) and G protein-coupled receptors (purple)
Neurology/psychiatric

Alkira Bio exits stealth via seed round to develop GPCR-targeting antibodies

July 30, 2024
By Tamra Sami
Alkira Bio, a new spinout from Australia’s Florey Institute of Neuroscience and Mental Health has emerged from stealth mode thanks to seed funding from Curie.bio. Although the amount of funding is not disclosed, Curie.bio typically invests $5 million to $10 million in a founder company and then co-pilots the drug discovery program, deploying drug development experts to its portfolio companies to help navigate decision making as part of the deal, Florey researcher turned Alkira Bio CEO Daniel Scott told BioWorld.
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Liver
Immune

PVT-201 gets US orphan status, cleared for Aussie trial

July 30, 2024
Parvus Therapeutics Inc.'s PVT-201 has received orphan drug status from the U.S. FDA for the treatment of primary biliary cholangitis (PBC), an autoimmune disease of the liver.
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Antibodies (light blue) and G protein-coupled receptors (purple)
Newco news

Alkira Bio exits stealth via seed round to develop GPCR-targeting antibodies

July 25, 2024
By Tamra Sami
Alkira Bio, a new spinout from Australia’s Florey Institute of Neuroscience and Mental Health has emerged from stealth mode thanks to seed funding from Curie.bio. Although the amount of funding is not disclosed, Curie.bio typically invests $5 million to $10 million in a founder company and then co-pilots the drug discovery program, deploying drug development experts to its portfolio companies to help navigate decision making as part of the deal, Florey researcher turned Alkira Bio CEO Daniel Scott told BioWorld.
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Cerebellum, brain stem, spinal cord

Alterity’s ATH-434 shows early response in multiple system atrophy

July 23, 2024
By Tamra Sami
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
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Elder care illustration

Australia looks to digital strategies for better elder care

July 19, 2024
By Tamra Sami
Australia’s Department of Health has released a new Aged Care Digital Strategy to increase the use of digital technology to enhance the care and wellbeing of older people in aged care facilities. By 2062, the number of people over 65 is expected to more than double, and the number of people over the age of 85 will more than triple. Australia’s aged care workforce is already under strain and will need to increase to meet this demand, a 2023 intergenerational report said.
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Cerebellum, brain stem, spinal cord

Alterity’s ATH-434 shows early response in multiple system atrophy

July 18, 2024
By Tamra Sami
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
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AI biotech research concept with lightbulb and digital background

Opyl, L39 Capital pick biotech winners with $100M fund and AI

July 16, 2024
By Tamra Sami
AI-driven clinical trial design company Opyl Ltd. formed a partnership with L39 Capital Pty Ltd. to establish a $100 million biotech fund that will showcase the predictive power of Opyl’s Trialkey software in selecting successful biotech and pharmaceutical stocks. Melbourne, Australia-based Opyl leverages AI to elevate clinical trial design and forecast outcomes, empowering clinical researchers, biopharma companies and investors to enhance trial design, drug development and market delivery.
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