Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
CONNEQT Health Lodges FDA Pre-Submission for SphygmoCor Cloud in Push toward Software Model
CONNEQT Health lodges FDA Pre-Submission for SphygmoCor Cloud, its cloud SaMD pivot with 510(k) target in FY27; could unlock subscription/licensing revenue.
Latest Stories — SECTOR DESK
Recce Pharmaceuticals Advances Diabetic Foot Infection Trial to Pivotal Phase 3
Recce Pharmaceuticals expands diabetic foot infection trial to Phase 3, broadening recruitment and adding below-knee ulcers; dual Australia-Indonesia program.
Adherium: Scaling Digital Respiratory Care and Assessing the US Payer Opportunity
Adherium pivots to US RPM subscriptions, pursuing Value-Based Care contracts as iCARE validates cost savings; targets 10k shipments and 40k patients in FY2026.
BCAL Diagnostics Develops Blood Test for Breast Cancer Recurrence Monitoring
BCAL Diagnostics launches BREASTEST Monitor—blood test to monitor post-treatment breast cancer recurrence; 91% sensitivity, 95% NPV.
Actinogen Gets Third DMC Green Light for XanaMIA as November Topline Nears
Actinogen's XanaMIA gets third DMC green light; trial proceeds unchanged as November 2026 topline readout nears, easing near-term interruption risk.
Dimerix Engages Everest Medicines to Commercialise DMX-200 Kidney Disease Treatment across Asia
Dimerix inks exclusive DMX-200 FSGS deal with Everest in Asia; upfront $14.1m, potential milestones up to ~$466m and 15% royalties.
EVE Health Group Initiates Pilot Study of Libbo Oral Soluble Film to Treat ED
EVE Health launches pilot Libbo ED study (oral soluble film), a key bioequivalence step toward regulatory approval; results expected by end-September. ASX:EVE
Five New Stocks For The Healthcare Sector Rotation: PME, TLX, TNE, 360, and SDR
ASX healthcare rotation heats up as PME, TLX, TNE, 360, SDR emerge—five stocks positioned to ride the sector shift amid oil, inflation and volatility.
Vitrafy Life Sciences Raising $30m to Scale Guardion Production and US Expansion
Vitrafy Life Sciences raises $30m to scale Guardion production and accelerate US expansion amid US blood market demand.
Island Pharmaceuticals Expands USAMRIID Agreement for Galidesivir Marburg Study
Island Pharmaceuticals expands USAMRIID CRADA to dose-optimise Galidesivir Marburg study; trials start next quarter; topline results H2 2026, a major milestone.
OncoSil FDA HDE Application Reaches Final Review as TRIPP-FFX Hits Endpoints
OncoSil's FDA HDE for distal cholangiocarcinoma advances to final review as TRIPP-FFX hits endpoints in pancreatic cancer; ASX: OSL.
LTR Pharma Signs Binding US Telehealth Term Sheet For ROXUS
LTR Pharma signs binding US telehealth term sheet with Shed Holdings for ROXUS via Mavrox; Definitive Agreements in 60 days to kickstart US commercialization.