Latest Regulatory Filings News

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

WA Kaolin Limited has initiated a partially underwritten pro-rata non-renounceable rights offer to raise up to $34.9 million, aiming to reduce debt, fund plant improvements, and restore working capital amid ongoing ASX suspension.

The Koala Company Limited has issued corrected Appendix 3X notices for directors Daniel Milham and Michael Gordon, clarifying escrow status and relevant interests in securities. This update follows a prior announcement on substantial holder notices and aims to ensure regulatory compliance.

Santana Minerals has finalised the second tranche of its A$130 million capital raising, issuing nearly 19 million shares and securing A$17.04 million before costs. The company confirms ongoing progress towards project construction scheduled for late 2026, supported by strong margins and green hydro power.

De.mem Limited has responded to an ASX query regarding the late lodgement of an Appendix 3Y for director Andreas Hendrik De Wit, attributing the delay to an administrative oversight. The company has outlined existing compliance protocols and introduced additional measures to prevent future lapses.

Eastern Gas Corporation Limited has addressed ASX concerns regarding trading by a non-executive director and a related entity during a closed period, outlining remedial actions and governance reviews.

Memphasys Limited (ASX: MEM) announced an investor webinar and released an updated presentation detailing its transition from early-stage commercialisation to scaling global revenues, highlighting multi-market sales, recurring cartridge revenue, and regulatory progress.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.

Tesoro Gold has issued a replacement Appendix 5B for the December 2025 quarter to correct an administrative error and reclassify certain deposits, ensuring consistency with its audited FY2025 financial statements.

CVC Limited has addressed ASX concerns over a delayed Appendix 3Y filing related to director John Leaver’s interest change, attributing the delay to administrative oversight while affirming existing compliance policies.

AVITA Medical has lodged a new $200 million shelf registration with the SEC, renewing its capacity to issue various securities in the US market. While no immediate capital raising is planned, this move preserves the company’s financial agility for future growth opportunities.