Latest Pharmaceutical Industry News

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

The Takeovers Panel has intervened in the Mayne Pharma and Cosette Pharmaceuticals scheme, issuing interim orders that extend the deal deadline and restrict termination rights to maintain the status quo.

The Takeovers Panel has issued interim orders extending the deadline for Mayne Pharma's takeover scheme with Cosette Pharmaceuticals, preventing termination without consent and maintaining the status quo.

Mayne Pharma updates shareholders on the extended Foreign Investment Review Board approval deadline and the rescheduled court hearing for its acquisition scheme by Cosette Australia BidCo.

Cryosite Limited reports a strong start to FY26 with a 22% revenue increase and a strategic warehouse acquisition that doubles capacity, positioning the company for sustained growth in clinical trial logistics.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

The Hydration Pharmaceuticals Company Limited reported a 55% reduction in half-year losses to $1.44 million, driven by strategic cost reductions and a sharpened focus on US e-commerce operations. Despite a 15% revenue decline, the company is banking on new product launches and retail expansion to fuel growth.

Mayne Pharma reported a 5% revenue increase to $408.1 million for FY25 but posted a net loss of $93.8 million, narrowing from the prior year. The company’s planned acquisition by Cosette Pharmaceuticals faces legal hurdles, delaying completion.

Island Pharmaceuticals reported a $3.92 million loss for FY2025 despite an 86% increase in income, with no dividends declared.

Algorae Pharmaceuticals reported a 62% reduction in net loss for FY2025, driven by R&D tax credits and cost efficiencies, while making significant strides in its AI drug discovery platform and therapeutic candidates.

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

Nova Eye Medical has reported a record A$29.3 million in FY25 revenue, driven by sustained US growth and operational improvements, setting the stage for breakeven EBITDA in the first half of FY26.