Latest Regulatory Affairs News

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Northern Minerals propels its Browns Range Heavy Rare Earths Project forward with a planned Final Investment Decision in Q3 2026 and a significant 40% increase in the Dazzler Deposit resource.

Acrux Limited’s FY26 receipts soared 960% to $5 million, fuelled by licensing milestones and growing generic sales, while FDA guidance clears the way for pivotal Phase III trials of its Female Testosterone therapy.

Rua Gold’s Auld Creek Project has qualified for New Zealand’s new Fast-Track Approvals Act 2024, promising a faster permitting timeline and reduced regulatory risk as the company advances toward mine development.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

Avecho Biotechnology has secured a unanimous recommendation to continue its Phase III insomnia trial without increasing sample size, alongside raising $1.9 million through option exercises and bolstering its cash position to $6.6 million.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

PYC Therapeutics has made significant progress across its four RNA therapeutic programs, including dose escalation approvals in its Polycystic Kidney Disease trial and orphan drug designation for its Retinitis Pigmentosa candidate, supported by a robust cash position of $669 million.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.