Latest Regulatory Risk News

Acrux pivots from generics to developing a Female Testosterone therapy for HSDD, leveraging FDA feedback and a strong US market opportunity.

PYC Therapeutics fortified its balance sheet by $600 million and progressed key RNA therapeutic trials in Q1 2026, setting the stage for pivotal clinical data and regulatory submissions.

Macro Metals’ subsidiary Macro Mining Services has landed an exclusive 36-month mining services contract with Metal Logic, supporting the rollout of innovative modular smelting technology in the East Pilbara. The first work package at Poondano Mine is set to start mid-2026, promising regional economic and Indigenous engagement benefits.

Newmont Corporation delivered a standout first quarter in 2026, reporting $3.3 billion net income and $3.1 billion free cash flow, while authorising an additional $6 billion share repurchase program after completing the previous one.

Qube Holdings Limited is set for a $9.3 billion cash takeover by a Macquarie-led consortium, with court approval granted to convene shareholder meetings in June. The scheme offers shareholders a 28% premium and is backed by an independent expert's fair and reasonable opinion.

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

Siren Gold continues its push to upgrade the Sams Creek gold resource with ongoing drilling and a mining permit application nearing decision. Meanwhile, exploration at Queen Charlotte reveals extensive high-grade gold and antimony mineralisation, underpinning the company’s strategic growth in New Zealand’s critical minerals sector.

Tartana Minerals has closed a $275,000 share placement to its directors at a significant premium, issuing 5.5 million shares and promising options exercisable at 5.5 cents. The company also flagged imminent settlement of a larger $1.7 million placement from earlier this year.

Peninsula Energy (ASX: PEN) has voluntarily suspended trading of its shares pending a Supreme Court decision on the validity of share sales made earlier this year. The court hearing, set for 22 April, will determine if required disclosures were properly made for sales between February and April 2026.

European Resources Limited (ASX: ERE) has repriced and relaunched a renounceable rights issue to raise up to $3.4 million, partially underwritten by Mahe Capital for $1.5 million, to fund metallurgical and exploration work at its Korsnäs rare earth project in Finland and Slovakian tenements.

Synlait Milk Limited confirms extended product release times and supply chain disruptions following The a2 Milk Company's update on its China infant formula business. The company maintains no FY26 guidance amid persistent industry risks.

Zinc of Ireland NL (ASX: ZMI) has entered a binding agreement to acquire Dutch metals technology company Meclex, integrating proprietary hydrometallurgical processes ARGO and VOLTA with its Kildare Zinc project. The company also announced a $5.5 million placement to support exploration and technology development alongside new board appointments.