Latest Regulatory Approvals News

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

Nickel Industries faced a challenging December quarter due to delayed regulatory approvals impacting ore sales, yet the company kicked off 2026 with robust nickel ore sales and record earnings from its HPAL project.

Riversgold Limited reports encouraging shallow gold intersections at its Northern Zone Gold Project near Kalgoorlie, supported by a $2.15 million capital raise with MEGA Resources as a key investor. The drilling results and strategic partnership set the stage for advancing mining plans in 2026.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Syrah Resources and Tesla have agreed to extend the cure date for an alleged default under their offtake agreement to March 2026, buying time to resolve ongoing qualification issues at Syrah’s Vidalia facility.

Larvotto Resources is on track to restart production at its Hillgrove Antimony-Gold Project by mid-2026, while progressing metallurgical testing at Eyre and due diligence on a copper acquisition at Mt Isa.

PolyNovo reports a robust 26% increase in group sales for 1H FY26, driven by strong U.S. market expansion and a near tripling of NovoSorb MTX sales. The company also completes a new manufacturing facility, positioning itself for sustained growth.

Tetratherix has inked a global exclusive distribution agreement with healthcare giant Henry Schein, paving the way for its first bone regeneration product, Tegenix, to enter major markets in 2026. Concurrently, the company has begun building an advanced manufacturing facility to meet expected global demand.

Buru Energy advances its Rafael Gas Project with strong funding interest and a $2.35 million capital raise, setting the stage for critical 2026 drilling and resource validation.

Tungsten Mining NL has released an updated financial analysis for its Mt Mulgine project, illustrating a substantial uplift in project economics driven by record-high tungsten and precious metal spot prices. While the study remains illustrative, it highlights the potential for accelerated development amid a robust commodity market.

Osteopore Limited has inked an exclusive collaboration with Majeton to commercialise its cutting-edge 3D-printed bioresorbable implants across China, Hong Kong, and Macau, unlocking significant growth potential in the region.

Bass Oil reported steady December production with a notable gas sales agreement for the Vanessa field, signaling a strategic shift towards gas commercialization.