Latest Clinical Stage Biotech News

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

Nyrada Inc has responded to ASX inquiries confirming the timely and compliant disclosure of positive safety data from its Phase I clinical trial of Xolatryp. The company detailed the timeline of its awareness and release of information, affirming adherence to continuous disclosure rules.

Tryptamine Therapeutics has locked in $2.6 million in non-dilutive funding to fast-track clinical trials of its lead psilocin-based therapy, TRP-8803, targeting binge eating disorder and other conditions.

Syntara Limited is set to update investors on the clinical progress of its lead drug candidate amsulostat, targeting myelofibrosis, in a webinar scheduled for 11 August 2025. The company highlights recent regulatory milestones and advancing trials.

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

Noxopharm Limited has successfully completed the second dose cohort in its HERACLES Phase 1 trial for SOF-SKN™, confirming safety and tolerability and moving forward to a higher dose. This progress marks a key step in developing a novel autoimmune disease treatment.

Noxopharm’s Sofra™ technology shows promising results in collaboration with US biotech Tezcat Biosciences, advancing targeted drug delivery for cancer and inflammatory diseases.

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.

Neurizon Therapeutics has secured a $1.5 million loan against its expected 2025 R&D tax rebate, boosting liquidity without diluting shareholders. This strategic move supports ongoing development of its neurodegenerative disease treatments.

Clarity Pharmaceuticals has completed a $203 million institutional placement at a premium, bolstering its cash reserves to nearly $288 million and positioning the company to advance pivotal clinical trials and commercial preparations for its cancer-fighting radiopharmaceuticals.

Noxopharm Limited has successfully completed the first low-dose cohort in its HERACLES clinical trial for SOF-SKN™, clearing the way for higher dose testing in autoimmune disease treatment.