Latest Fda Approvals News

The week was split between big earnings reactions and small-cap rocks-and-rigs rallies. Pro Medicus sank despite record numbers, while a handful of explorers jumped on fresh discoveries and policy wins.

Healthcare stocks split into two stories this week: big names sold off hard, while a few small caps ran on clear news. The biggest moves came from a sharp fall in Pro Medicus and Cochlear, while Noxopharm jumped after a top-tier journal publication.

AVITA Medical reported an 11% increase in sales revenue for 2025, driven by deeper market penetration and new product launches, while reducing its net loss by 21%. The company secured a $60 million senior secured credit facility but flagged substantial doubt about its ability to continue as a going concern.

Neuren Pharmaceuticals has initiated a discretionary on-market share buy-back program of up to 5%, citing a strong cash position and undervaluation relative to internal and analyst assessments.

A single exploration name blew the doors off the leaderboard, while two well-known uranium plays and a Nevada explorer sank hard. Behind the noise: deals got closer to completion, big raisings reset prices, and several “good news” gaps didn’t survive the week.

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

Neuren Pharmaceuticals has dosed the first patient in its groundbreaking Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome, a rare genetic disorder with no approved therapies. The trial marks a significant step forward for the PMS community and rare disease drug development.

The US Congress has reauthorized the Rare Pediatric Disease Priority Review Voucher program through September 2029, a move that could significantly benefit Neuren Pharmaceuticals as it advances its rare disease drug candidates.

Cyclopharm Limited is accelerating its US market push for Technegas with a A$16 million capital raise following a record 2025 sales performance. The company aims to expand its US installations and advance new clinical applications beyond pulmonary embolism.

Island Pharmaceuticals has raised $9 million to advance its antiviral drug Galidesivir through the FDA’s Animal Rule pathway, targeting inclusion in the US Strategic National Stockpile for biodefense viruses.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

Imricor Medical Systems has welcomed Oklahoma Heart Institute as the fourth U.S. site in its pivotal VISABL-AFL clinical trial, accelerating patient recruitment and the FDA approval pathway for its MRI-guided cardiac ablation technology.