Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Patrys Advances RLS-2201 Program with Manufacturing Start and FDA Regulatory Engagement
Patrys kicks off RLS-2201 manufacturing with BioCina and FDA 505(b)(2) engagement, targeting Phase 0 trials in H2 2026.
Latest Stories
Dimerix Completes Adult Dosing for ACTION3 DMX-200 Trial
Dimerix completes adult dosing for ACTION3 DMX-200 in FSGS; 333 patients vs 286 target, boosting statistical power and de-risking regulatory submission.
Orthocell Appoints Exclusive Remplir Distributor Ahead of UK Rollout
Orthocell names LEDA Orthopaedics exclusive UK distributor for Remplir ahead of regulatory approval, signaling rapid UK rollout and market prep.
EVE Health Advances Reformulated Drugs Targeting Sexual Health and Cardiovascular Markets
EVE Health advances reformulated ED/PE sprays and Apixaban delivery, expanding its sexual health and cardiovascular pipeline.
Island Pharma Expands Antiviral Pipeline with Burnet Institute Collaboration and NHMRC Funding
Island Pharma expands antiviral pipeline with Burnet Institute; NHMRC grant of over $780k to back ISLA-101, accelerating Galidesivir MVD program.
Archer Materials is Building a Scalable Path to Commercial Quantum Technology
Archer Materials (ASX: AXE) charts a scalable, semiconductor-ready path to commercial quantum tech with the 12CQ project, targeting a 2026 qubit.
Island Pharma Partners with USAMRIID and Geneva Foundation for Galidesivir under FDA Animal Rule
Island Pharma signs a 3-year CRADA with USAMRIID and Geneva Foundation to fast-track Galidesivir for Marburg under FDA Animal Rule, eyeing NDA.
Bioxyne Boosts FY26 Outlook on Strong Performance and International Growth
Bioxyne lifts FY26 EBITDA guidance to AUD16.5-19m after record H1 FY2026 with AUD31.3m revenue (+149% YoY); expands capacity, enters UK/Germany/LATAM.
Radiopharm Theranostics Doses First Patient in RV-01 Phase 1/2a Trial for Aggressive Cancers
RAD doses first patient in RV-01 Phase 1/2a trial for aggressive cancers, a 177Lu-radiotherapeutic targeting B7-H3, to define dose for future studies.
Lumos Diagnostics Achieves BARDA Paediatric Study Milestone, Secures US$720k Payment
Lumos Diagnostics hits BARDA Milestone 6, secures US$720k non-dilutive payment as FebriDx paediatric study advances toward FDA submission and wider US TAM.
Little Green Pharma to Divest WA Production Site in $7.8 Million Sale and Lease-Back Deal
LGP to sell WA production site for $7.8m in a sale-and-lease-back to fund Australian and European expansion; settlement targeted mid-March 2026.
Cyclopharm Secures NIH Approval for Technegas, Boosting US Expansion
Cyclopharm wins NIH approval for Technegas, secures US purchase order; installation under FSS imminent as funding targets 250-300 US installs by H2 2026.