Latest Pharmacokinetics News

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.

Amplia Therapeutics has commenced dosing the first patient in its new pancreatic cancer trial combining narmafotinib with FOLFIRINOX chemotherapy, marking a key milestone in its drug development journey.

Argenica Therapeutics has reported positive Phase 2 trial results for ARG-007 in acute ischemic stroke patients, confirming safety and revealing a promising efficacy signal in a high-risk subgroup with slow collateral blood flow.

Race Oncology has activated its first clinical trial site in Hong Kong for the Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours, marking a significant step in accelerating patient enrolment and broadening clinical data.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

InhaleRx has secured ethics approval to begin a Phase 1 clinical trial of IRX-616a, a synthetic cannabidiol inhaler aimed at providing fast relief for panic disorder. The fully funded study will assess safety and pharmacokinetics in healthy volunteers.