Latest Clinical Trial Progress News

Cleo Diagnostics has laid out a clear U.S. reimbursement pathway for its ovarian cancer test, leveraging an existing CPT code to enable early market entry and data collection ahead of FDA clearance.

Anteris Technologies reported a $22.9 million net loss in Q1 2026 but bolstered its cash position to $283 million following a $320 million capital raise. The company is scaling manufacturing and clinical activities for its DurAVR transcatheter heart valve, with US patient enrolment now underway in the pivotal PARADIGM Trial.

Resonance Health upgrades its FY26 underlying EBITDA guidance to $2.6 million, driven by operational efficiencies and growth in its Software-as-Medical Devices segment, despite a slight revenue timing delay.

Recce Pharmaceuticals bolsters its clinical and commercial pipeline with a $5.3 million AUD R&D tax rebate, a second U.S. Army research agreement for its RECCE 327 Gel, and a key patent granted in Brazil, while progressing Phase 3 trials in Indonesia.

Resonance Health reports strong cash flow and progress in clinical trials, with a record forward order pipeline for its Software-as-a-Medical-Device business and profitable trial site clinics.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Racura Oncology has detailed how its lead drug candidate, (E,E)-bisantrene, silences the cancer-driving MYC gene by stabilising G-quadruplex DNA structures, providing critical preclinical validation ahead of ongoing clinical trials.

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.

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.

Recce Pharmaceuticals has expanded its intellectual property footprint with a newly granted patent in Brazil, protecting its innovative synthetic anti-infectives against a broad range of infections. This milestone strengthens Recce’s position in one of South America’s largest antibiotic markets.

Immutep Limited has voluntarily suspended trading of its shares on the ASX pending the release of a key announcement regarding the interim futility analysis of its TACTI-004 Phase III trial. The suspension underscores the market’s anticipation of potentially pivotal clinical trial results.

Radiopharm Theranostics reported a 44% increase in net loss to $27 million for the half-year ended December 2025, driven by expanded R&D spending. The company bolstered its cash reserves through a $35 million placement while progressing multiple clinical trials across its radiopharmaceutical pipeline.