Latest Regulatory Affairs News

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

BlinkLab has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.

Marvel Gold Limited has extended the completion date for the sale of its Mali gold projects to August 2025 due to ongoing regulatory delays, signaling cautious navigation of complex local approvals.

Prescient Therapeutics has opened a Share Purchase Plan to raise up to $7 million, offering shareholders discounted shares to fund the Phase 2 development of its targeted cancer therapy PTX-100.

Prescient Therapeutics has launched a $7 million Share Purchase Plan at a notable discount to fund the next phase of clinical trials for its promising PTX-100 cancer therapy. The capital raise aims to accelerate progress toward regulatory approval and patient access.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

The Takeovers Panel has received a contentious application challenging Keybridge Capital’s role in the Yowie takeover bid, spotlighting conflicts of interest tied to WAM Active’s influence. Interim orders were declined, leaving the dispute unresolved as a critical shareholder meeting unfolds.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

Syntara Limited has unveiled encouraging interim Phase 2a data for SNT-5505, an add-on therapy targeting myelofibrosis patients with suboptimal response to ruxolitinib. The data highlight meaningful symptom relief and spleen volume reduction, positioning the drug as a potential game-changer in a challenging treatment landscape.