Latest Fda News

Syntara Limited’s FY2026 results show a 7.9% revenue decline and a 13.6% increase in net loss amid significant clinical progress, including FDA backing for its lead drug amsulostat and a successful $8.8 million capital raise.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

ImpediMed reported a 15% revenue increase to $14.6 million in FY26, broadened reimbursement coverage for its SOZO platform to 95% of the US population, and launched new applications in heart health and weight management.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.

Neuren Pharmaceuticals reported an 8% rise in H1 2026 revenues driven by DAYBUE royalties, but profit fell 68% due to ramped-up R&D. The company declared its first ever dividend, signalling confidence amid ongoing clinical and regulatory milestones.

Prescient Therapeutics (ASX:PTX) has opened a $7 million Share Purchase Plan at a significant discount to advance its lead cancer therapy PTX-100 beyond a pivotal Dose Optimisation Committee review in late 2026.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.

Control Bionics has secured MHRA registration for its NeuroStrip device, unlocking commercial supply in Great Britain and launching early trials with leading UK institutions.

Prescient Therapeutics launches a $7 million Share Purchase Plan at an 18.8% discount to fund advancement of its PTX-100 cancer therapy beyond a key 2026 Dose Optimisation Committee review.