Latest Pharmaceuticals News

Mayne Pharma Group has proposed a $7.40 per share acquisition by Cosette Pharmaceuticals, with unanimous board support and a fair and reasonable opinion from an independent expert. Shareholders will vote on the scheme on June 18, 2025.

Sigma Healthcare has released its standalone annual and sustainability reports for the year ending January 2025, marking the final disclosures before its merger with Chemist Warehouse Group in February 2025.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Amplia Therapeutics reports a significant milestone in its ACCENT trial, with 15 confirmed partial responses indicating that narmafotinib combined with chemotherapy outperforms chemotherapy alone in advanced pancreatic cancer.

Mayne Pharma has voluntarily withdrawn a speaker presentation for its contraceptive NEXTSTELLIS® following an FDA Untitled Letter concerning promotional claims. The company confirms this does not impact sales or its planned merger with Cosette.

Mayne Pharma has addressed a sharp share price decline following the public release of an FDA Untitled Letter, confirming no undisclosed material information and reaffirming compliance with ASX rules.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

Botanix Pharmaceuticals has clarified that recent share price movements are linked to a rumored US executive order on drug pricing, confirming no undisclosed material information. The company reassures investors of compliance with ASX disclosure rules amid market speculation.

Botanix Pharmaceuticals clarifies its lead product Sofdra is unlikely to face price cuts under the proposed US executive order on drug pricing, citing its exclusive US market approval and distinct formulations abroad.

Mayne Pharma Group has acknowledged a delayed filing of a director's interest notice due to administrative oversight and is taking steps to reinforce compliance with ASX disclosure rules.

Acrux Limited, partnering with TruPharma, has introduced its Dapsone 7.5% Gel in the US, featuring a unique tube packaging that aims to improve patient convenience and reduce environmental impact.

Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.