Latest Real World Evidence News

Medical Developments International returned to EBIT profitability in FY26 as Penthrox volumes strengthened across Australian hospitals and Europe. The company now faces the less glamorous test of converting regulatory progress into repeatable demand while absorbing weaker Respiratory sales and new amortisation costs.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Emyria has presented its regulated Australian psychedelic-treatment experience to the US FDA, putting clinical delivery systems rather than drug development at the centre of its US ambitions. The appearance raises the company’s profile, but does not yet disclose regulatory approval, a commercial agreement or a financial commitment.

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.