Latest Real World Evidence News

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

Optiscan Imaging has reached an 84-case milestone in its live digital pathology study with Australian Clinical Labs, testing the InForm platform across a broad range of tissue types and disease settings. The data may support future regulatory submissions and commercial discussions, but the announcement does not disclose diagnostic accuracy metrics or regulatory approval.

Phoslock Environmental Technologies has advanced a new range of lanthanum-enhanced phosphorus-binding products showing up to four times the capacity of current offerings, with pilot and manufacturing tests confirming strong performance and low lanthanum release. Field trials are underway, aiming for commercial sales in 2027.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

LTR Pharma is shifting gears from clinical trials to commercial rollout, securing US partnerships for ROXUS and reporting encouraging SPONTAN Phase II data that supports FDA approval ambitions.

Medical Developments International (ASX:MVP) reported a 9% revenue increase to $42.6 million and a 566% jump in net profit to $0.6 million for FY26, driven by robust growth in its Pain Management segment and expanded paediatric approvals in Europe.

LTR Pharma reports a 93% response rate in men seeking convenience and spontaneity with SPONTAN, alongside a 64% response in post-prostatectomy patients, highlighting potential for its rapid-onset intranasal ED treatment in challenging populations.

Rhythm Biosciences bolstered its financial position with a $5.2 million option underwriting while accelerating commercial adoption of its ColoSTAT® colorectal cancer test and advancing geneType™ partnerships internationally in Q4 FY26.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

The Therapeutic Goods Administration has broadened the range of clinicians eligible to participate in psychedelic-assisted psychotherapy, a move set to speed up recruitment and improve patient access across Emyria’s national Empax network.