Latest Regulatory Filings News

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Algorae Pharmaceuticals has advanced its AI drug discovery capabilities with the launch of AlgoraeOS v2 and secured key commercial partnerships, including a $3 million debt facility to support expansion in Australia and New Zealand.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

A takeover offer lit up small caps, while one high-growth software name slid hard despite strong sector news. Resources dominated the winners list, but investors still punished dilution and discounted fundraisings.

Australian Strategic Materials and Energy Fuels are set to discuss their proposed acquisition in a joint webcast, offering investors a closer look at this strategic move.

Telix Pharmaceuticals has met its upgraded FY 2025 revenue guidance with US$804 million, driven by strong growth in its Precision Medicine segment and the successful US launch of Gozellix. The company also advanced multiple clinical trials and announced a strategic collaboration with Varian to combine radiopharmaceuticals with radiation therapy.

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.

Finder Energy has completed a $5.2 million capital raise through a share placement to its directors and substantial shareholder Longreach Capital, following shareholder approval.

Racura Oncology has launched a strategic collaboration with Emory University to investigate (E,E)-bisantrene’s potential to overcome resistance to osimertinib in EGFR-mutated non-small cell lung cancer. This partnership aims to bolster Racura’s HARNESS-1 clinical trial and strengthen its position in the competitive lung cancer treatment landscape.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.