Latest Clinical Pipeline News

Invion Limited has secured a pivotal FDA Orphan Drug Designation for its lead cancer drug INV043, bolstered its balance sheet with nearly $1.8 million in new funding, and progressed clinical trials targeting skin and anogenital cancers.

Dimerix Limited reports solid progress in its Phase 3 trial for DMX-200 targeting rare kidney disease FSGS, backed by orphan drug status in Japan and a robust cash position. The company prepares to engage the FDA on new data supporting regulatory approval.

Radiopharm Theranostics has secured FDA approval to initiate a Phase I trial targeting B7H3 and raised A$40 million to accelerate its radiopharmaceutical programs. The company also appointed renowned oncologist Dr Oliver Sartor to its Scientific Advisory Board.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

CSL Limited has revised its financial outlook for FY26, citing lower US influenza vaccination rates and government cost controls in China, while postponing the planned demerger of its Seqirus vaccine business and announcing a major cost-saving program.

Starpharma has secured two major partnership agreements with Genentech and Radiopharm Theranostics, unlocking significant upfront payments and milestone potential while advancing its clinical pipeline.

Cambium Bio has locked in a significant R&D tax rebate and forged three strategic partnerships, underpinning its Phase 3 clinical trials for its lead ophthalmology biologic. The company’s recent capital raise further strengthens its runway as it prepares for pivotal trial milestones.

Radiopharm Theranostics has announced a $40 million equity raise via a two-tranche placement and a Share Purchase Plan (SPP) to fund its clinical programs and working capital. The offer includes new shares at $0.03 each with free attaching options, subject to shareholder approval.

Radiopharm Theranostics has completed a A$35 million institutional placement and launched a A$5 million Share Purchase Plan, both at $0.03 per share, to fund drug manufacturing and clinical trials through 2027.

Telix Pharmaceuticals reports a robust 53% revenue jump in Q3 2025 and raises its full-year guidance, underpinned by key reimbursement wins and expanding clinical programs.

Mesoblast has entered agreements to issue up to US$50 million in convertible notes, aiming to strengthen its capital base and support pipeline growth, pending shareholder approval.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.