Latest Regulation News

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

Parkway Corporate Limited (ASX:PWN) delivered a sharp revenue increase in FY26 and generated positive operating cash flow, but slipped into a statutory loss and flagged significant uncertainty around its ability to continue as a going concern. Key approvals for its Queensland brine project and a new $2 million mining contract offer commercial progress, while funding remains the central test.

SkyCity has appointed UBS and Chapman Tripp to run a structured process exploring potential transactions and other ways to lift shareholder value, while continuing talks with two parties whose earlier approaches were rejected. The casino operator also expects major asset sale proceeds and says cost savings are tracking ahead of plan.

Chalice Mining is moving Gonneville from study to execution, with a feasibility study underway and a targeted investment decision in the first half of 2028. The project’s sizeable economics sit alongside a A$26.2 million annual loss and a funding task that remains unresolved.

St George Mining’s Araxá project now boasts a 111.2Mt rare earths resource after a major post-year-end upgrade, alongside 630,000 tonnes of contained niobium. The 2026 annual report shows a company moving rapidly towards development, but still without an ore reserve, mine design or production decision.

The Takeovers Panel has allowed Pengana Capital Group to withdraw its challenge to Pengana International Equities’ buy-back and proposed rights issue, but stopped short of endorsing the transactions. The regulator said it remained concerned about the structure and warned that settlement terms must not obstruct future proceedings.

Heartland Group Holdings (NZX: HGH, ASX: HGH) more than doubled FY2026 net profit as margins widened, asset quality improved and its proposed TSB merger moved towards a shareholder vote. The bank also reported a 16% fall in restated emissions, though much of its climate-risk work remains incomplete or estimate-driven.

Brazilian Critical Minerals has reported striking economics for its Ema rare earths project, including a US$1.47 billion post-tax NPV, 105% IRR and six-month payback. The company’s A$7.87 million FY2026 loss, December debt maturity, permitting requirements and unresolved Drake dispute leave the development case dependent on execution and further funding.

Rubicon Water’s technology has been selected as part of a joint venture bid for a major Moroccan irrigation upgrade covering 69,600 hectares. The opportunity could become its largest EMEA contract, but formal execution remains subject to a 15-day appeal period and subsequent commissioning.

American Tungsten & Antimony has submitted a confidential draft Form F-1 to US regulators, moving its proposed Level III ADR listing on Nasdaq into formal review. The company also extended the Del Sol transaction end date by three weeks, leaving both major initiatives progressing but unfinished.

Synlait’s operational recovery gathered pace in the second half, but the NZX-listed dairy processor still reported a NZ$75.4 million FY26 loss and negative operating cash flow. KPMG flagged a material uncertainty over going concern as the company prepares to refinance facilities due in 2027.