Latest Market Exclusivity News

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Zoono Group has inked a five-year exclusive contract with Sharpak and OSY to apply its antimicrobial technology on UK soft fruit packaging, aiming to reduce food waste and boost shelf-life.

Streamplay Studio Limited has inked an exclusive agreement to bring its cloud gaming service to Sri Lanka’s largest mobile network, Dialog Axiata, targeting over 19 million subscribers. This expansion follows its recent successful launch in the UAE, positioning Streamplay for growth in emerging mobile-first markets.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Botanix Pharmaceuticals clarifies its lead product Sofdra is unlikely to face price cuts under the proposed US executive order on drug pricing, citing its exclusive US market approval and distinct formulations abroad.

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

Nuchev Limited has entered an exclusive sales agency agreement with Brauer Natural Medicines and H&S Brand Corporation, expanding its footprint in Australia's natural and complementary medicines sector. The deal covers key brands including Brauer, Skin Physics, and Rapid Loss, with potential for broader ANZ distribution.

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.

Neurizon Therapeutics reported a sharp rise in half-year losses to $7.28 million but marked significant progress with its lead drug NUZ-001 entering a major ALS clinical trial and securing critical regulatory designations.

Recce Pharmaceuticals reports strong Phase II results for its RECCE® 327 topical gel, achieving a 93% efficacy rate in treating serious skin infections and setting the stage for accelerated Phase 3 trials.

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.