Latest Clinical Data News

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

Neuren Pharmaceuticals has added SYNGAP1-related disorder to its NNZ-2591 development program following encouraging pre-clinical findings, targeting a rare condition with no approved treatments.

AVITA Medical’s Q2 2025 update reveals a temporary setback in RECELL demand due to Medicare reimbursement delays, offset by strong revenue growth and promising clinical data. The company anticipates recovery and renewed growth in the second half of the year.

Alterity Therapeutics faces ASX scrutiny after mistakenly marking multiple announcements as market sensitive, prompting a review of its disclosure practices. The biotech denies any intent to manipulate its share price despite repeated errors.

Rhythm Biosciences has advanced its ColoSTAT® diagnostic kits to final production validation, demonstrating consistent detection of colorectal cancer across all stages in a pivotal study. The company is gearing up for regulatory submission and commercial launch later this year.

Nyrada Inc. has raised $8.25 million through a strategic placement to fund its upcoming Phase IIa clinical trial of Xolatryp for acute myocardial infarction, positioning the company for a pivotal year ahead.

Chimeric Therapeutics has progressed its CHM CDH17 CAR-T cell therapy to dose level 2 in its Phase 1/2 trial, showing promising early anti-tumor activity and a strong safety profile in gastrointestinal and neuroendocrine cancers.

Adherium Limited reports a robust 30% increase in US remote patient monitoring users and closes a $4.5 million capital raise, positioning itself for accelerated growth under new leadership.

Vectus Biosystems confirms safety of its lead fibrosis drug VB0004 from Phase Ia/Ib trials and advances licensing talks globally, including in China, while managing costs and funding challenges.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Argent BioPharma has achieved a significant milestone by commencing formal supply of its EU-GMP cannabinoid API for epilepsy treatment at a leading Slovenian hospital and gaining prescription approval for CannEpil™ in Germany, marking key steps in its European expansion.

Invion Limited has secured a $20,000 grant to support its anogenital cancer trial and progressed its skin cancer study with promising early results, while raising approximately $1 million through a Loyalty Option Entitlement Offer.