Latest Regulatory Filings News

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

European Lithium (ASX: EUR) has obtained a crucial ASX waiver allowing it to cancel unlisted options and performance rights without shareholder approval, smoothing the path for its acquisition by NASDAQ-listed Critical Metals Corp (NASDAQ: CRML).

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

EQT’s controlled entity has upped its non-binding offer for Perpetual to A$22.07 per share, a 2% premium on its initial bid. The proposal hinges on Perpetual’s Wealth Management sale and other conditions, with no certainty of a deal.

Amaero has taken a key step toward listing in the US by confidentially submitting its draft registration statement to the SEC, though pricing and timing remain undecided.

Loyal Metals has cleared a key regulatory hurdle with ASIC registering the Scheme Booklet for its proposed A$0.45 per share acquisition by PT Bumi Resources. The Independent Expert endorses the deal as fair and reasonable, while Loyal’s board unanimously backs the scheme, setting the stage for a shareholder vote.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

The Supreme Court of New South Wales has approved the scheme of arrangement for Rubik Australia to acquire Qube Holdings, setting the stage for trading suspension and ownership transfer.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Po Valley Energy has lodged a crucial Environmental Impact Assessment for a four-well gas drilling program at its Selva Malvezzi concession in Northern Italy, aiming to boost production and support regional energy needs.