Latest Regulatory Submissions News

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Bio-Gene Technology has raised A$3.21 million to complete critical safety studies for its novel insecticide Flavocide and ramp up production of its natural insecticide Qcide, advancing its path to commercialisation in multiple global markets.

Mt Malcolm Mines (ASX:M2M) is gearing up for a major drilling campaign at its Calypso Gold Prospect, aiming to convert a substantial Exploration Target into a JORC-compliant Mineral Resource. The program follows high-grade discoveries at the newly identified T3 Constance Lode and historical multi-lode mineralisation.

Vitrafy Life Sciences has achieved a major validation milestone with US Army-backed Phase II results showing its no-wash platelet cryopreservation protocol delivers 94% post-thaw recovery, outperforming existing standards and advancing FDA registration plans.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

Lumos Diagnostics advances US commercial rollout of FebriDx with positive reimbursement data and expanded urgent care adoption ahead of the 2027/28 flu season.

Coda Minerals has launched critical drilling and environmental programmes at its Elizabeth Creek Copper-Silver Project, underpinning its Pre-Feasibility Study and potential resource expansion.

Anteris Technologies reported a $22.9 million net loss in Q1 2026 but bolstered its cash position to $283 million following a $320 million capital raise. The company is scaling manufacturing and clinical activities for its DurAVR transcatheter heart valve, with US patient enrolment now underway in the pivotal PARADIGM Trial.

Avecho Biotechnology has bolstered its cash reserves by $1.9 million through the exercise of listed options, positioning the company for a pivotal Phase III interim analysis readout for its insomnia treatment.

BPH Global inks binding deal with Temasek Innovation Holdings to validate its seaweed-based male vitality product through targeted biological assays, advancing regulatory and commercial ambitions.

Noxopharm’s SOF-16 active ingredient demonstrated potent anti-inflammatory activity in patient-derived samples of systemic lupus erythematosus and rheumatoid arthritis, advancing its Sofra™ platform beyond topical applications.

Recce Pharmaceuticals bolsters its clinical and commercial pipeline with a $5.3 million AUD R&D tax rebate, a second U.S. Army research agreement for its RECCE 327 Gel, and a key patent granted in Brazil, while progressing Phase 3 trials in Indonesia.