Latest Oncology News

Immutep Limited has won FDA Orphan Drug Designation for its immunotherapy eftilagimod alfa in treating soft tissue sarcoma, opening regulatory incentives and potential market exclusivity. This follows encouraging Phase II data despite recent Phase III trial setbacks.

Nyrada has secured ethics approval to start its Phase IIa trial of Xolatryp in heart attack patients, with recruitment beginning in April 2026. The biotech also bolsters its cash position to AU$6.74 million and pursues new oncology indications.

Telix Pharmaceuticals has initiated a US$550 million convertible bonds offering to refinance existing 2029 bonds and support general corporate purposes, securing low-cost, non-dilutive financing with a conversion premium above current share price.

Percheron Therapeutics has closed a $2.2 million entitlement offer to advance its HMBD-002 immuno-oncology candidate towards a phase II trial in 2026, backed by strong shareholder and new investor support.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Arovella Therapeutics has demonstrated that its novel CLDN18.2-targeting CAR incorporated into iNKT cells effectively eliminates pancreatic and gastric cancer cells in vitro, with IL-12-TM armouring enhancing potency and durability.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.