Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies

Clarity Pharmaceuticals Granted Breakthrough Therapy Designation for Prostate Cancer Copper Theranostic
Clarity Pharmaceuticals wins FDA breakthrough status for prostate cancer PET agent 64Cu-SAR-bisPSMA, a major milestone for its copper theranostic program.
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BlinkLab Reports Positive Results from Smartphone-Based Study into Genetic Autism
BlinkLab reports positive SHANK2 autism study results, with its smartphone test detecting significant differences in brain and sensorimotor measures.

EVE Health Group Signs Australian Pharmacy Deal for Men's Health Range
EVE Health signs Australian pharmacy deal for its men’s health range, retaining 75% of distributable profit in a capital-light route to market.

Immutep Reports Exposure-Dependent Inhibition of T-Cell-Driven Responses in IMP761 Phase I Study
Immutep’s IMP761 showed significant, exposure-dependent suppression of T-cell responses in Phase I, with no serious or severe adverse events.

Mayne Pharma Sells International Operations for $55.5m to Focus on US Business
Mayne Pharma sells international operations for $55.5m, sharpening its focus on US Women’s Health, Dermatology and DistributeRx growth.

Pacific Edge Wins US Medicare Coverage for Cxbladder Triage Tests
Pacific Edge secures US Medicare coverage for Cxbladder tests, opening an estimated 1.14 million annual testing opportunities.

Radiopharm Theranostics and FDA Agree on Design of Phase 3 RAD101 Trial for Brain Metastases
Radiopharm Theranostics secures FDA agreement on pivotal Phase 3 RAD101 trial, advancing its brain metastasis imaging agent toward clinical validation.

INOVIQ Signs Agreement with Sonic Healthcare to Advance EXO-OC Ovarian Cancer Detection Test
INOVIQ partners with Sonic Healthcare USA to validate its EXO-OC ovarian cancer test, advancing a potential US commercialisation pathway.

Adherium Lifts Recurring Revenue as Hailie Usage Expands
Adherium lifts subscription revenue 12.5% to $539,000 for a fifth quarterly record as Hailie activations grow and US care contracts loom.

Ceryvyn Therapeutics Moves CYV-101 Lung Disease Program Closer to Clinical Testing
Ceryvyn advances CYV-101 lung disease program towards clinical testing, adds specialist imaging and reports $27.5 million in cash.

Clever Culture Systems Advances Sales Pipeline for APAS Independence
Clever Culture Systems advances APAS sales pipeline after three transactions, with purchase orders expected from global pharma customers.

Oneview Healthcare Adds Six Customers as Bedside Hub Gains Traction
Oneview Healthcare adds six customers, with four Bedside Hub deals already meeting its second-half target as US hospital demand builds.