Latest Pharmacokinetics News

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.

LTR Pharma has made significant strides towards its US market debut with ROXUS, bolstered by expert appointments and peer-reviewed clinical data validating its rapid-onset ED treatments.

Actinogen Medical has fast-tracked enrolment in its pivotal Alzheimer’s trial, secured a clear FDA regulatory path, and strengthened its financial position with funding extending its runway to mid-2026.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

Nyrada has completed its Phase I trial for Xolatryp, confirming safety and predictable pharmacokinetics, while securing AU$8.25 million to fund an upcoming Phase IIa trial targeting heart attack patients.

Radiopharm Theranostics has received a positive safety recommendation to increase the dose of its radiotherapeutic 177Lu-RAD202 in the Phase 1 HEAT trial for HER2-positive advanced solid tumors, signaling promising early results.

Nyrada Inc. has announced successful Phase I trial results for its lead drug candidate Xolatryp, confirming safety and pharmacokinetics that pave the way for a Phase IIa trial targeting heart attack patients next year.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Pathkey.AI has upgraded its TrialKey platform to include drug-level molecular and pharmacokinetic features, enhancing clinical trial predictions and opening doors to AI-driven drug discovery.