Latest Pharmacokinetics News

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

Immutep Limited reports encouraging Phase I results for IMP761, a novel LAG-3 agonist antibody targeting autoimmune diseases, demonstrating dose-dependent immunosuppression and a strong safety profile. Further trial updates are expected in early 2026.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

InhaleRx has boosted its funding facility by $12.6 million to accelerate clinical trials of SRX-25, a novel oral treatment for Treatment-Resistant Depression. This brings total available capital to $52.3 million, positioning the company for pivotal Phase III studies.

LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.

InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.

Race Oncology has received ethics approval to launch its HARNESS-1 Phase 1a/b trial testing RC220 combined with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward addressing resistance to current therapies.

Patrys Limited has expanded its clinical pipeline by acquiring Reliis Pty Ltd, gaining a proprietary injectable formulation of Quetiapine aimed at the large and underserved delirium market. This strategic move balances Patrys’ portfolio with a near-term pharmaceutical asset alongside its biologics program.

Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug candidate NUZ-001 and strengthened its balance sheet with a $5.2 million capital raise. The company is now poised to enter the pivotal HEALEY ALS Platform Trial, marking a significant step forward in its neurodegenerative disease program.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.