Latest Clinical Guidelines News

Patrys has formed an international Clinical Advisory Committee to help shape the next stages of RLS-2202, its injectable quetiapine candidate for delirium in acute-care settings. The appointments add recognised expertise in delirium research, intensive care and trial design, but do not yet provide clinical efficacy or regulatory evidence.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

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.

Cyclopharm Limited posted a fifth consecutive record half-year revenue of $17.5 million, propelled by a 74% jump in US Technegas® sales and a doubling of revenue-generating US sites. New US clinical guidelines naming Technegas® as the preferred ventilation imaging agent underpin a robust growth outlook despite a wider net loss.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Cyclopharm Limited delivered a record $17.1 million in revenue for 1H FY26, driven by a 73% surge in US Technegas® sales. However, delays in clinical guideline publication have pushed the short-term US installation target beyond 2026, while medium-term ambitions remain intact.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Cyclopharm Limited is rapidly expanding its Technegas® lung imaging technology across the US, securing new contracts and advancing clinical guideline recognition that could boost adoption.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.