Latest Regulatory Reviews News

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

NuEnergy Gas Limited has completed drilling three wells and commenced initial gas sales at its Tanjung Enim PSC in Indonesia, marking a key step toward full-scale production. Regulatory approvals and commercial agreements are advancing, positioning the company for growth in the unconventional gas sector.

HeraMED has bolstered its cash position with a $1.98 million capital raise and is on the cusp of finalizing two pivotal U.S. commercial agreements, signaling a major step forward for its digital maternity care platform.

Vintage Energy reported a 24% drop in quarterly sales revenue to $0.9 million alongside a 20% production decline, while initiating a Production Uplift Program targeting its Southern Flank gas fields and maintaining steady 2P reserves at 12.5 MMboe.

Anteris Technologies has enrolled the first patients in its pivotal PARADIGM Trial, testing the DurAVR Transcatheter Heart Valve against leading competitors in a global study.

Pilbara Minerals has delivered a robust start to FY26, boosting lithium production and revenue while cutting unit costs at its Pilgangoora operation. The company also advances key growth projects amid a volatile lithium market.

Apiam Animal Health Limited has entered a binding agreement with Adamantem Capital Fund II for a $228.4 million acquisition via a scheme of arrangement, offering shareholders a significant premium and flexible cash or scrip consideration options.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Mayne Pharma’s planned acquisition by Cosette Pharmaceuticals faces a delay as the Foreign Investment Review Board postpones its decision, potentially pushing back key court proceedings.

Health Canada has requested additional information, extending its review of CLINUVEL’s SCENESSE® for erythropoietic protoporphyria (EPP) into 2026. Meanwhile, Canadian patients continue to access the treatment via a Special Access Program.

RPMGlobal Holdings Limited has agreed to be acquired by Caterpillar Inc. through a Scheme of Arrangement valuing the company at over $1.1 billion, offering shareholders a 32.6% premium. The deal awaits regulatory and shareholder approvals, marking a significant consolidation in mining software technology.

Ainsworth Game Technology’s CEO Harald Neumann faces a setback as the Nevada Gaming Control Board recommends withdrawing his license application, prompting a board review of his role.