PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on further strengthening reforms for adverse events and postmarket regulations for medical devices.

PERTH, Australia – Antisense Therapeutics Ltd. saw its stock bounce 26% following the news that the FDA has granted rare pediatric disease designation for ATL-1102 for the treatment of Duchenne muscular dystrophy (DMD), following submission of phase II data that showed its immunomodulatory therapy met primary disease progression endpoints. 

PERTH, Australia – Starpharma Holdings Ltd. completed a AU$45 million (US$32 million) placement to domestic and international investors that will see it advance its COVID-19 antiviral nasal spray. The treatment is based on the company’s antiviral dendrimer, SPL-7013, which inactivates viruses by blocking the interaction between viral surface proteins and the human cell receptor proteins.

PERTH, Australia – Brandon Capital announced the launch of Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication.

PERTH, Australia – Sydney-based Recce Pharmaceuticals Ltd. completed a placement of AU$27.95 million (US$19.69 million) to advance its synthetic anti-infective pipeline.

PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).

PERTH, Australia – Australia’s largest health care venture capital firm, Brandon Capital, announced the launch of Australian biotech company Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication.

PERTH, Australia – Sydney-based Recce Pharmaceuticals Ltd. completed a placement of AU$27.95 million (US$19.69 million) to advance its synthetic anti-infective pipeline to address antibiotic-resistant superbugs and emerging viral pathogens.

PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).