Latest Regulatory Engagement News

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.

LGI Limited has launched a $5 million Share Purchase Plan offering eligible shareholders in Australia and New Zealand the chance to buy additional shares at a slight discount. The capital raise aims to fund the acceleration of key renewable energy projects.

Immutep Limited reports strong progress in its Phase III lung cancer trial with over 170 patients enrolled, alongside positive FDA feedback and a robust cash position supporting ongoing development.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting genetic diseases, alongside a strong cash runway supporting ongoing development.

Brazilian Critical Minerals has successfully produced a high-grade mixed rare earth carbonate containing 50% total rare earth oxides from low-grade field leach solutions at its Ema Project, validating its in-situ recovery process and commercial viability.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Battery Age Minerals (ASX – BM8) showcased its global portfolio of critical minerals projects at the Ignite Investment Summit in Hong Kong, highlighting maiden drilling at Austria’s Bleiberg germanium project, a newly granted drill permit for Argentina’s El Aguila gold-silver system, and ongoing lithium exploration in Canada’s Falcon Lake.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.