Latest Clinical Development News

LTR Pharma has appointed Associate Professor Darren Katz, a leading urologist and erectile dysfunction expert, to its Scientific Advisory Board, aiming to fast-track the development and commercialization of its innovative nasal spray treatments SPONTAN and ROXUS.

ITM Isotope Technologies Munich SE and Radiopharm Theranostics have entered a strategic supply agreement for the critical radioisotope Lutetium-177, underpinning Radiopharm’s clinical development of targeted cancer therapies.

Recce Pharmaceuticals has successfully raised A$8.4 million through an entitlement offer and placement to fund pivotal Phase 3 clinical trials, advancing its synthetic anti-infective pipeline towards commercialisation in 2026.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.

Nyrada’s experimental drug NYR-BI03 shows promising cardioprotective and anti-arrhythmic effects in animal models, reinforcing its potential as a treatment for acute myocardial infarction.

Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.

AdAlta Limited has announced a pro rata renounceable rights offer to raise approximately $1.29 million, aiming to fund its strategic pivot towards licensing CAR-T cell therapies through its subsidiary AdCella. The offer includes new shares and options, underpinned by key insiders and an underwriting agreement.

Neurizon Therapeutics has announced the successful completion of its Open-Label Extension study for NUZ-001 in ALS, revealing significant survival benefits and strong tolerability. The company is on track to release top-line results in Q3 2025 and advance to a pivotal Phase 2/3 trial.

Immutep’s combination of eftilagimod alfa (efti) and KEYTRUDA® delivers a striking 17.6-month median overall survival in head and neck cancer patients with low PD-L1 expression, a group with limited treatment options.

Nyrada Inc. has cleared the Safety Review Committee’s scrutiny for its Phase I clinical trial, progressing to the third dosing cohort of its promising neuroprotective and cardioprotective drug candidate NYR-BI03.

Recce Pharmaceuticals reports strong Phase II clinical trial results for its topical anti-infective R327G, achieving a 93% efficacy rate in treating ABSSSI, alongside a significant capital raise to fund upcoming Phase III trials.