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Radiopharm Theranostics has reached agreement with the US Food and Drug Administration on the design of a single pivotal Phase 3 trial for RAD101, its imaging agent for brain metastases.

Island Pharmaceuticals has started surgical preparations on the 22 nonhuman primates that will take part in its Galidesivir dose optimisation study for Marburg virus disease.

OncoSil Medical has applied to regulators to manufacture its OncoSil device at a Macquarie Park, Sydney facility. The company said it hopes to start commercial production at the facility in the second half of the 2027 financial year.

The funds enable the Melbourne company to pay out its convertible note holder and avoid a further drawdown on that facility before its lead ALS drug reaches a pivotal trial readout next year.

Mesoblast is farewelling two of its longest-serving and most technically experienced directors as the cell therapy company reshapes its board for what it calls the next phase of commercial delivery and growth.

Noxopharm has secured commitments for a $1.5 million placement and will offer existing shareholders up to a further $1 million to fund the next clinical study of SOF-SKN, its topical therapy for cutaneous lupus erythematosus.

Neuren Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration for NNZ-2591 as a treatment for neonatal hypoxic-ischemic encephalopathy, or HIE, a brain injury that affects newborns.

A small Melbourne company founded by two medical researchers has landed one of Australia's biggest potential licensing deals.

BCAL Diagnostics has secured a seat on Genetic Signatures' board, though it is only part of what it asked for. At an Extraordinary General Meeting, shareholders voted to appoint Dr John Melki to the GSS board but rejected the other three resolutions BCAL had put forward.

Melbourne biotech Magellan Stem Cells is 17 years old and about to begin a pivotal Phase 3 trial of its stem cell treatment for osteoarthritis, a condition affecting more than 2 million Australians. Yet under legislation now before the Federal Parliament, it may also lose access to the refundable R&D Tax Incentive.

AusBiotech says the Government's R&D tax bill still penalises the clinical trial and manufacturing companies Australia most wants to keep. The industry body is now pushing for changes in the Senate.

The Melbourne company dosed the first patient in its Beyond Harmony study of NTI164 on 21 September. All six sites across Victoria, Queensland, New South Wales, Tasmania and Western Australia are now open.