Latest Safety News

CSL has secured an exclusive agreement to co-develop and co-promote Alentis Therapeutics’ investigational drug lixudebart, committing US$355 million upfront and funding a multi-trial development programme. The antibody remains unapproved, with its commercial potential dependent on results from ongoing and planned clinical studies.

Alkane Resources has reported a transformational FY2026, with the Mandalay merger helping lift revenue to A$935.8 million and profit after tax to A$228.7 million. The enlarged gold and antimony producer has also declared its first dividend and approved a buy-back, while setting broadly stable production guidance for FY2027.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

BSA is proposing to acquire aerial infrastructure technology business Eonetics in a largely scrip-based transaction that would leave the sellers with about 39.9% of BSA. The deal remains non-binding, with one seller yet to sign and multiple approvals still required.

Acusensus has exercised a second six-month extension to its NSW mobile speed camera agreement, adding an estimated $16 million in contracted value through June 2027. The more consequential question remains unresolved: whether the company can convert the ongoing tender into a longer-term deal.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

ClearVue Technologies reported just A$108,484 of FY2026 revenue against an A$11.86 million loss, while consuming A$8.69 million in operating cash. The solar-glazing developer says certifications, international partners and an 80-project pipeline have strengthened its platform, but the next test is converting those assets into cash revenue.

KGL Resources says its Jervois copper project is funded through construction and ramp-up after a US$300 million Wheaton agreement and a post-year-end A$300 million equity raising. The company is now targeting a final investment decision in the second half of 2026 and first copper concentrate in 2028, while its annual report highlights the execution risks still attached to that timetable.

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.

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.

Jupiter Mines delivered above-target production and sales at its Tshipi manganese mine in FY26, but higher costs and a stronger South African rand pulled group profit lower. The year also brought a new majority co-investor, a leadership transition and fresh questions around the mine’s resource and reserve base.