Latest Patient Access News

LTR Pharma Limited (ASX, LTP) reported significant progress in FY25, advancing its novel intranasal treatments for erectile dysfunction and expanding its commercial footprint in Australia and the US. The company secured key partnerships and capital raises, positioning itself for regulatory milestones and global market entry.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Emyria Limited reports a reduced net loss of $3.14 million for FY2025, driven by strategic expansion in psychedelic-assisted mental health treatments and key partnerships including insurer Medibank. The company advances clinical services while continuing R&D on proprietary medicines.

BCAL Diagnostics has partnered with Sonic Healthcare Australia to broaden access to its innovative blood-based breast cancer test, BREASTEST plus™, across Sydney. This move formalizes a commercial rollout following successful trials and aims to improve early detection for women with dense breast tissue.

Race Oncology Limited reported a significantly reduced loss for FY2025, driven by key clinical trial progress and strategic leadership changes. The company advances its RC220 program with promising Phase 1 dosing milestones and strengthens its governance to support future growth.

Actinogen Medical reports steady progress in its Alzheimer’s and depression drug trials, backed by strong funding and strategic commercial planning. Key interim data from the pivotal XanaMIA trial is expected early next year.

CSL Limited posted a 14% rise in net profit for FY2025, underpinned by strong immunoglobulin sales and new product launches, while announcing plans to demerge its vaccines business, CSL Seqirus, to sharpen strategic focus.

Syntara Limited is set to update investors on the clinical progress of its lead drug candidate amsulostat, targeting myelofibrosis, in a webinar scheduled for 11 August 2025. The company highlights recent regulatory milestones and advancing trials.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

Recce Pharmaceuticals advances its clinical pipeline with expanded Phase 3 trials in Indonesia and Australia, backed by a $15.8 million capital raise and a $30 million debt facility.

Prescient Therapeutics has raised nearly $10 million through a placement and share purchase plan to advance its promising PTX-100 targeted cancer therapy into pivotal clinical stages.