Latest Pharmacokinetics News

Nyrada has moved its PROTECT-MI heart-attack trial into active recruitment, with four hospitals open and three patients dosed. The biotech also reported supportive US FDA feedback, encouraging preclinical oncology data and AU$13.72 million in cash after a AU$12 million placement.

Neurotech International has moved NTI164 into a registration-enabling Phase III autism trial, but its annual report carries a material going-concern warning. The company says post-year-end debt and equity funding should support the program through topline data, subject to execution and completion.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Patrys has moved its injectable quetiapine program into human testing, while its FY2026 annual report warns the company will need further funding within 12 months. The company ended the year with $3.36 million in cash after raising capital and acquiring the RLS-2202 development program.

Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.

Patrys has formed an international Clinical Advisory Committee to help shape the next stages of RLS-2202, its injectable quetiapine candidate for delirium in acute-care settings. The appointments add recognised expertise in delirium research, intensive care and trial design, but do not yet provide clinical efficacy or regulatory evidence.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

Patrys has cleared a key regulatory hurdle with Human Research Ethics Committee approval for its Phase 1A clinical trial of RLS-2202, aiming to start dosing healthy volunteers this quarter.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.