Latest Pharmaceuticals News

Neuren’s partner Acadia secures positive CHMP opinion for DAYBU® in Rett syndrome, paving the way for first EU treatment approval and triggering significant milestone payments for Neuren.

Recce Pharmaceuticals secured A$4 million through an institutional placement and launched a Share Purchase Plan to raise up to an additional A$4 million, bolstering funds for commercial licensing and ongoing clinical programs.

LTR Pharma’s intranasal spray OROFLOW® has secured ethics approval for a clinical study targeting oesophageal motility disorders, marking its first foray beyond erectile dysfunction. The study, led by Dr Peter Wu, aims to validate a non-invasive alternative for swallowing difficulties in a market projected to reach US$8.1 billion by 2034.

AFT Pharmaceuticals surged 22% to NZ$254.7 million revenue in FY26, surpassing profit guidance and securing FDA approval to advance a pivotal injectable iron Phase III trial targeting a $7.4 billion market. The company is poised for further global expansion and product launches in FY27.

AFT Pharmaceuticals delivered a 22% revenue jump in FY26 to NZD 254.7 million, surpassing profit guidance and expanding its footprint to 87 countries. The company is advancing multiple R&D projects, including a pivotal Phase III injectable iron trial, while targeting over NZD 300 million in revenue for FY27.

Recce Pharmaceuticals has secured ethics approval to upgrade and broaden its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, accelerating recruitment and reinforcing its global registration ambitions.

Island Pharmaceuticals has won a key regulatory boost as the US FDA granted Orphan Drug Designation to Galidesivir for post-exposure prophylaxis of Marburg virus disease, enhancing its commercial and development prospects.

CLINUVEL Pharmaceuticals has lodged its Form 20-F with the U.S. SEC, seeking to elevate its American Depository Receipt program to a Nasdaq-listed American Depository Share, aiming to boost visibility and liquidity without raising capital.

LTR Pharma has confirmed it disclosed a binding US commercialisation agreement for ROXUS promptly after signing, responding to ASX scrutiny over pre-announcement trading activity.

Paradigm Biopharmaceuticals has completed enrolment ahead of schedule in its pivotal Phase 3 trial for Zilosul®, enrolling 538 patients with knee osteoarthritis and maintaining its timeline for interim and final results.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

LTR Pharma has locked in Strive Specialties as its exclusive US pharmacy fulfilment partner for ROXUS, marking a critical step towards commercial launch in the US erectile dysfunction market.