Latest Fda News

Immuron delivered record FY26 sales, a narrower loss and a much stronger cash balance, while shifting clinical development towards commercial partners. The annual report also flags a material weakness in inventory controls and confirms that IMM-529 remains dependent on a future licensing deal.

Nexsen has paused its StrepSure clinical programme after an interim review identified performance improvements needed before a US FDA submission, pushing the target timetable back by roughly one quarter. Its shares were then suspended pending an announcement about a potentially material contract for an additional device.

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.

4DMedical delivered sharp growth in scans, sites and operating revenue as CT:VQ moved into commercial deployment across several global markets. But the company remains loss-making and its auditor issued a qualified opinion over the carrying value of goodwill and other intangible assets.

Cleo Diagnostics has begun developing a multi-biomarker blood test for ovarian cancer screening in asymptomatic women, targeting a stated $150 billion global market. The prototype program will run alongside the company’s pre-surgical test, with initial proof-of-concept data expected early next quarter.

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.

PainChek grew recurring revenue, implemented licences and customer sites in FY2026, but its $8.94 million loss and $9.24 million operating cash outflow prompted an explicit going-concern warning from its auditor. The company is now betting that US deployments and a sharper commercial focus can convert market access into cash-generating growth.

Actinogen Medical has completed the final patient visit in its 247-participant XanaMIA Alzheimer’s disease trial, keeping topline results on track for November 2026. The milestone closes patient participation in the pivotal study, but provides no indication yet of whether Xanamem improved outcomes.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

Telix will acquire ITM in a proposed US$1.65 billion deal that combines a commercial radioisotope supplier with Telix’s precision medicine and therapeutic pipeline. The transaction could give Telix greater supply-chain control and entry into a validated cancer treatment market, but it also brings dilution, integration risk and an unresolved FDA pathway for ITM-11.

CurveBeam AI has raised A$1.75 million through an oversubscribed SPP shortfall offer and placement, lifting its recent capital raised to A$7.36 million. The funds will support the HiRise China launch, product development, supply-chain preparation and working capital.

Echo IQ says it sees a path to US FDA clearance for EchoSolv HF after receiving a Not Substantially Equivalent determination. The company is weighing an appeal, an Ombudsman review or a fresh 510(k) submission, but has not selected a route or set a firm timetable.