Latest Regulatory Affairs News

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Echelon Resources Limited has agreed to postpone accepting Horizon Oil Limited's off-market takeover bid for Cue Energy Resources Limited shares it controls, excluding those under a pre-bid agreement, until 13 April 2026.

Apollo Minerals Limited has validated significant historical tungsten intercepts up to 5.3% WO3 in unmined areas of its Couflens Project in France, highlighting exploration potential around the Veronique Zone and advancing preparations for further drilling.

Memphasys Limited (ASX: MEM) announced an investor webinar and released an updated presentation detailing its transition from early-stage commercialisation to scaling global revenues, highlighting multi-market sales, recurring cartridge revenue, and regulatory progress.

Nexsen Limited's subsidiary has won a HK$6 million grant to accelerate clinical validation and manufacturing of its rapid Group B Streptococcus diagnostic in Hong Kong, positioning the city as a key Asia-Pacific hub.

Alterity Therapeutics has secured encouraging regulatory feedback from the FDA on its ATH434 Phase 3 program for Multiple System Atrophy, marking a critical step towards pivotal trial initiation.

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Atomo Diagnostics has responded to an ASX price query following unusual trading activity, denying any undisclosed price-sensitive information while acknowledging a related FDA update involving Lumos Diagnostics.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

Biotron Limited reveals that its lead antiviral candidate BIT-HBV001 shows promising activity against Hepatitis Delta Virus, expanding its potential impact beyond Hepatitis B. Meanwhile, the company completes integration of Sedarex and advances regulatory plans for its anaesthetic SedRx.

Neurotech International has opened the first clinical site for its pivotal Phase 3 trial of NTI164, targeting core symptoms of Autism Spectrum Disorder in children. This milestone marks a key step toward potential regulatory approval and commercialisation.

Dimerix Limited is set to conduct a blinded statistical review of its pivotal Phase 3 ACTION3 study in March 2026, aiming to confirm the trial remains powered to demonstrate the primary endpoint of proteinuria reduction in FSGS patients.