Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Avecho Biotechnology Advances Phase III Insomnia Trial to Full Enrolment Size
Avecho Biotechnology Phase III insomnia trial moves to full enrolment after DMB recommendation; no serious adverse events in first 244 participants.
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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.
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.