Latest Fda News

Saluda Medical delivered 28% FY26 revenue growth and expanded its spinal cord stimulation opportunity with CAP24, but its annual report warns that additional capital may be needed within 12 months. The ASX-listed medical device company also begins FY27 under new CEO Michael Mathias.

Argent BioPharma ended the September quarter with just A$11,000 in cash after A$734,000 of operating outflows, despite retaining A$7.4 million of unused convertible financing capacity. The company is simultaneously expanding its commercial portfolio through NLC antiviral rights and a CannEpil veterinary programme.

Arovella Therapeutics has received a $4.03 million FY2026 R&D tax refund, giving the clinical-stage biotech additional cash as it advances its lead therapy ALA-101 towards first-patient dosing. The payment arrives without any accompanying clinical data or disclosed update to the company’s cash runway.

Cleo Diagnostics’ prototype ovarian cancer screening test met or exceeded every predefined performance target in a 247-person proof-of-concept study, including among 62 Stage I cases. The result moves the program into larger bridging and expanded studies, but it remains retrospective evidence rather than a validated screening test.

Telix reported US$245 million in unaudited third-quarter revenue, with Precision Medicine sales up 30% and full-year revenue and other income still expected to exceed US$1 billion. The quarter also advanced the proposed US$1.65 billion ITM merger, added FDA-approved Pixclara to the commercial portfolio and narrowed the R&D spending range.

CurveBeam AI has secured its strongest first-quarter HiRise sales result, gained China regulatory clearance and raised A$7.35 million to fund the next stage of commercialisation. The progress comes alongside lower customer receipts and a reported 4.3 quarters of cash runway.

EBR Systems has submitted its WiSE wireless cardiac pacing system for Australian regulatory approval, opening a potential second commercial market after the United States. The application has entered a priority review pathway, but neither approval nor an assessment timetable is guaranteed.

Actinogen Medical says its pivotal XanaMIA Alzheimer’s trial remains on course for topline results in November after the final patient visit was completed. The company also reported $15.9 million in cash, a further $5.3 million from option funding and a projected runway into late 2027 or 2028, assuming future trials are substantially partner-funded.

Acrux has received clearer FDA guidance for Phase III trials of its female testosterone spray, including potential three-year data exclusivity if the product reaches submission. The company also reported positive September-quarter operating cash flow, but that result was largely driven by a $1.977 million R&D tax rebate and Acrux says it is still pursuing funding for the clinical programme.

Nyrada has moved its PROTECT-MI heart-attack trial into active recruitment, with four hospitals open and three patients dosed. The biotech also reported supportive US FDA feedback, encouraging preclinical oncology data and AU$13.72 million in cash after a AU$12 million placement.

AdAlta expects an additional R&D Tax Incentive refund of more than A$1 million after securing approval for specified overseas work on its EW-001 CAR-T therapy. The cash benefit arrives as the company prepares for a US FDA pre-IND meeting in November.

Noxopharm has completed its first-in-human safety trial for SOF-SKN and advanced the wider Sofra platform, but its annual report flags a material uncertainty over funding. The biotech ended June with A$293,573 in cash, net liabilities of A$3.65 million and a need for additional capital.