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

BlinkLab Raises A$17.5m to Fund FDA Autism Diagnostic Clearance and Advance ADHD Trials
BlinkLab raises oversubscribed A$17.5m to push FDA autism Dx1 clearance and start ADHD Dx2 trials; Morocco rollout underpins real-world data.
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Genetic Signatures Inks 10-Year Danish Supply Deal for GI Screening Technology
GSS signs 10-year Danish deal with Hvidovre Hospital for EasyScreen Pan-Enteric; boosts recurring revenue, EMEA growth; first-year 28k samples from Sept 2026.

Orthocell Secures Access to 221 US Military & VA Medical Centres for Remplir
Orthocell wins access to 221 US DoD/VA centres for Remplir, a major US market expansion as HY26 revenue hits A$6.2m and cash sits at A$49.4m.

Immutep Granted FDA Orphan Drug Designation for Efti in Soft Tissue Sarcoma
Immutep wins FDA Orphan Drug Designation for eftilagimod alfa in soft tissue sarcoma, boosting exclusivity and regulatory support as TACTI-004 winds down.

AVITA Medical Reports Accelerating Grafting Times in Positive Interim Results for Cohealyx-I Study
AVITA Medical reports Cohealyx-I interim: mean grafting 13.6 days vs 33.2 benchmark; early grafting, strong clinician adoption signals.

PainChek Inks Landmark 20,000-Bed North America Deployment with Sabra Health Care REIT
PainChek inks landmark 20,000-bed North American deployment with Sabra Health Care REIT across 329 facilities, funding beds at $55-75/bed/yr.

Entropy Neurodynamics' TRP-8803 Trial Shows Repeatable Psychedelic Effects in BED Study
Entropy Neurodynamics reports repeatable psychedelic effects in TRP-8803 BED trial; Cohort 2 enrollment advancing; R&D incentives boost cash runway.

Pacific Edge Test Volumes Rise 2.7% in Q4 on Payer Expansion
Pacific Edge (PEB) Q4 test volumes rise 2.7% on payer expansion; eyes Medicare LCD draft by Sept 2026 as coverage broadens, signaling regulatory momentum.

Imricor Medical Systems Advances US Strategy with Pediatric Label Expansion Submission
Imricor submits pediatric NorthStar label via 510(k) to FDA, targeting 250 US children's hospitals; clearance expected this quarter to drive US growth.

Amplia Therapeutics Halts AMPLICITY Trial Recruitment After Chemo-Related DLTs
Amplia Therapeutics halts AMPLICITY recruitment after DLTs with narmafotinib mFOLFIRINOX; pivots to new combos, delaying readouts and raising investor risk.

Firebrick Pharma Raises $1.5m to Advance Product Development and Commercial Expansion
Firebrick raises $1.5m via 31.9m shares at $0.047, 16.5% discount to VWAP with 1-for-2 options; Indonesia grants Nasodine approval, unlocking SE Asia growth.

Nexsen Awarded $1.2m Grant to Advance Strepsure Point-Of-Care Diagnostic in Asia-Pacific Markets
Nexsen awarded $1.2m grant to advance StrepSure GBS test in Asia-Pacific; Hong Kong as hub for validation, local manufacturing and near-term commercialization.