Latest Pharmaceuticals News

Island Pharmaceuticals has secured key regulatory milestones for its antiviral Galidesivir, including FDA confirmation of the Animal Rule pathway and Priority Review Voucher eligibility, while strengthening US biodefense ties and expanding patent protection.

Botanix Pharmaceuticals reported a robust 28% increase in net revenue for Sofdra in Q2 FY26, driven by a 24% rise in prescriptions and a growing US sales team. The company maintains a strong cash position while navigating higher operating costs.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Algorae Pharmaceuticals has locked in a $3 million revolving debt facility with ScotPac, providing flexible, non-dilutive funding to accelerate its commercial operations across Australia and New Zealand.

Firebrick Pharma has introduced its Nasodine Throat Spray in Singapore, marking its first international product launch and setting the stage for further global rollouts in 2026.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Recce Pharmaceuticals has received a $5.3 million R&D tax rebate from the Australian Taxation Office, providing a significant cash injection to support its innovative synthetic anti-infective drug development programs.

Clinuvel Pharmaceuticals has initiated dosing in a preclinical study of its novel controlled-release injectable peptide platform, VLRX-L, aiming to enhance drug delivery for melanocortin-based therapies. Preliminary results are expected in the second half of 2026.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Island Pharmaceuticals has been granted a key US patent for Galidesivir, extending intellectual property protection through 2031 for treating filoviridae viruses including Marburg and Ebola. This milestone aligns with the company’s clinical development strategy and recent FDA regulatory progress.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.