Latest Biotechnology News

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

Chimeric Therapeutics remains suspended from ASX trading after failing to lodge its FY2026 financial statements, with the company reporting an approximate $7.7 million net asset deficiency and unresolved creditor negotiations. Potential recapitalisation interest has emerged, but no binding funding or settlement agreement has been reached.

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

Paradigm Biopharmaceuticals has entered voluntary administration after its pivotal Phase 3 trial produced an interim efficacy result below the threshold required for continuation. The company’s securities will remain suspended while administrators assess its viability, liabilities and possible restructuring options.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Ocean Sciences delivered a sharp increase in seaweed revenue during FY2026, but the audited report also records a A$1.612 million continuing-operations loss, A$2.319 million operating cash outflow and material uncertainty over its ability to continue as a going concern. The renamed ASX-listed group is now seeking up to A$3 million while building out its Indonesian platform.

Neuren says its partner Acadia has received a US Notice of Allowance for a trofinetide patent that could protect weight-banded dosing through 28 March 2041. The patent has not yet formally issued, but the allowance could extend US protection by almost five years beyond the existing method-of-use patent.

Memphasys will receive an A$3.5 million advance from major shareholder Peters Investments to expand Felix production, inventory and sales capacity as repeat orders emerge across international markets. The funding carries a 12.5% interest rate, potential equity dilution and requires shareholder and ASX approvals before the convertible notes can be issued.

Cynata Therapeutics (ASX:CYP) has reported a $9.25 million loss, negative net assets and a material uncertainty over going concern after its two major clinical trials failed to demonstrate efficacy. The company has since cut its workforce to zero, shifted management to the board and secured a $600,000 R&D tax incentive loan while it considers the future of its Cymerus platform.

Paradigm Biopharmaceuticals will keep its ASX securities suspended until at least 30 September while it reviews interim Phase 3 data and assesses the operational and financial consequences. The company also remains in discussions with Obsidian Global GP, LLC, but has not disclosed the trial results or their direction.

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

Prescient Therapeutics has raised approximately $6 million through its Share Purchase Plan and a shortfall placement, giving PTX-100 additional funding beyond a key clinical review in December. The next test is whether early results support a move into Phase 2b development.