Latest Clinical Stage Biotech News

Radiopharm Theranostics (ASX:RAD) is raising up to $18.5 million via a two-tranche placement, a share purchase plan, and a concurrent US offering, aiming to bolster its clinical programs and working capital.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Amplia Therapeutics reported encouraging mature data from its ACCENT pancreatic cancer trial showing improved survival and response rates with narmafotinib. The company raised $27.5 million to fund development and manufacturing scale-up, while discontinuing a parallel trial due to chemotherapy toxicity.

Noxopharm’s Sofra™ oligonucleotides, delivered via InhaTarget’s inhalable lipid nanoparticles, achieved a significant reduction in lung inflammation in preclinical models, broadening Sofra’s therapeutic reach and delivery versatility.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Neurizon Therapeutics has secured an additional A$2.7 million through a placement addressing the shortfall from its entitlement offer, lifting total proceeds to approximately A$8.5 million. This fresh capital strengthens the biotech’s balance sheet and provides financial flexibility as it advances its lead ALS drug NUZ-001 through pivotal clinical stages.

Noxopharm Limited's CEO and Managing Director Dr Gisela Mautner has resigned after four years with the company, including leading a key strategic pivot. The biotech firm plans to announce her successor shortly.

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Imugene Limited has launched a $20 million equity raising comprising a $12 million placement and an $8 million Share Purchase Plan, alongside issuing options, convertible notes, and warrants to support its azer-cel clinical program.

Neurizon Therapeutics announces the resignation of CEO Dr Michael Thurn, with Executive Chair Sergio Duchini stepping in temporarily as the company embarks on a global hunt for new leadership.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Entropy Neurodynamics has received a $1.73 million R&D tax incentive refund from the Australian Government, reinforcing its clinical development of an intravenous psilocin treatment for neuropsychiatric disorders.