Latest Market Exclusivity News

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Osteopore Limited reports a three-fold increase in craniofacial implant sales within a year of signing an exclusive distribution deal with Zimmer Biomet, signaling strong early traction across key global markets.

Sprintex has landed a landmark three-year private-label supply agreement worth A$9.3 million with Guangdong Baode Technology, marking its entry into China’s vast aquaculture market.

Invex Therapeutics has broadened its collaboration with Tessara Therapeutics to explore Exenatide’s potential in Alzheimer’s disease, while successfully renewing key orphan drug designations in Europe and the US.

Sprintex Limited has boosted its Türkiye presence by extending its exclusive distribution deal, securing a new A$377,000 order, and launching larger Jet Blowers aimed at industrial and municipal markets.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

dorsaVi has secured exclusive worldwide rights to cutting-edge RRAM technology from NTU Singapore, promising to revolutionize its wearable sensor products with enhanced performance and energy efficiency. This strategic move positions the company for expansion into healthcare, elite sports, and industrial IoT markets.

Cyclopharm Limited has secured the maximum five-year U.S. patent extension for its flagship Technegas® Kit, extending market exclusivity to 2031 and reinforcing its strategic foothold in pulmonary imaging.

Anagenics Limited’s proprietary hair regrowth technology powers the newly launched Bouf Haircare brand, which has achieved over $500,000 in sales in its first week, setting the stage for a lucrative royalty stream.

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.