Latest Patient Access News

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Chimeric Therapeutics reported a reduced net loss of $10.43 million for FY2025, driven by cost efficiencies and strategic project reprioritisation, while making significant clinical progress in its CAR T-cell and NK cell therapy programs.

Prescient Therapeutics has completed a $3 million share placement, bolstering its clinical development programs for innovative cancer treatments including PTX-100 and novel cell therapies.

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.