Latest Regulatory Submissions News

Orthocell’s new study confirms Remplir™ delivers superior nerve regeneration and faster muscle recovery compared to traditional sutures, bolstering its US market rollout plans.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

Recce Pharmaceuticals has locked in a non-dilutive A$30 million debt facility with Avenue Capital Group, extending its cash runway to support pivotal Phase 3 trials and commercialisation of its synthetic anti-infective R327G.

EVE Health Group’s subsidiary Nextract has inked a pivotal two-year agreement with TeleDocs Clinic, enabling nationwide online prescribing of its upcoming erectile dysfunction and dysmenorrhea products ahead of regulatory approval.

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.

EVE Health Group has completed its acquisition of Nextract Pty Ltd, positioning itself to enter the lucrative erectile dysfunction and dysmenorrhea markets with innovative drug delivery technologies.

Optiscan Imaging Ltd has launched InSpecta™, a cutting-edge microscopic imaging device tailored for veterinary medicine, marking its strategic entry into a booming $12 billion US market. The device promises to revolutionize diagnostics and treatment for companion animals with real-time, non-invasive imaging.

Recce Pharmaceuticals has completed a A$15.8 million capital raise to fund pivotal Phase 3 clinical trials and progress its FDA application, positioning the company for potential commercial breakthroughs in antibiotic-resistant infections.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

EVE Health Group has initiated stability testing for its novel oral treatments targeting erectile dysfunction and dysmenorrhea, marking a crucial step toward regulatory approval in Australia. The company also finalizes its acquisition of Nextract, the developer behind these innovative formulations.

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.

Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.