Latest Pharmaceuticals News

Mayne Pharma rebuffs Cosette's claim of a material adverse change in their merger scheme and secures FDA clearance on regulatory concerns, maintaining its commitment to the deal's completion.

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.

Cardiex Limited has gained Therapeutic Goods Administration approval for its CONNEQT Pulse device, paving the way for commercial expansion in Australia alongside its established US presence.

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.

EVE Health Group has successfully passed all shareholder resolutions at its recent General Meeting, paving the way for its acquisition of Nextract Pty Ltd and announcing significant leadership changes.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

Avecho Biotechnology has received $1.66 million from the Australian Government’s R&D Tax Incentive, reinforcing its commitment to a pivotal Phase III trial for its CBD-based insomnia treatment and accelerating its commercial ambitions.

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.

ALS Limited has announced a fully underwritten A$350 million equity placement to fund major upgrades to its global laboratory network and support future growth initiatives, aiming for mid single-digit EPS accretion by FY25 pro forma.

ALS Limited delivered a robust FY25 performance with 16% revenue growth to $3 billion and underlying EBIT rising 4.7% to $515 million, driven by strong organic growth and strategic acquisitions. The company is advancing its Nuvisan integration ahead of schedule and has unveiled a $230 million investment plan to expand key laboratories, positioning itself for sustained growth amid market uncertainties.