Latest Biotechnology News

PYC Therapeutics has reported positive safety outcomes from its Phase 1 trial of PYC-001 for Autosomal Dominant Optic Atrophy, paving the way for a global Phase 1/2 study later this year.

Immutep Limited has enrolled over 170 patients in its global Phase III TACTI-004 trial for advanced non-small cell lung cancer, surpassing the threshold needed for a futility analysis expected in early 2026.

Anatara Lifesciences has completed the first tranche of its two-part share placement, issuing over 33 million ordinary shares to professional investors. This move marks a significant step in the company’s capital raising efforts amid ongoing product development.

Immuron Limited has taken a significant step forward by submitting an Investigational New Drug application to the FDA for IMM-529, targeting Clostridioides difficile infection. The company aims to start Phase 2 trials in early 2026, addressing a critical unmet need in infectious disease treatment.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

The U.S. FDA has lifted the clinical hold on Neurizon Therapeutics’ lead drug candidate NUZ-001, enabling its entry into a major ALS platform trial set for Q4 2025. This regulatory milestone accelerates the company’s clinical development and opens doors for broader neurodegenerative applications.

Invex Therapeutics has ended negotiations on two neurological asset acquisitions following due diligence setbacks and shareholder disputes, while advancing R&D collaborations and managing financial stability.

Arovella Therapeutics has demonstrated that its novel CLDN18.2 CAR-T cells effectively eliminate pancreatic cancer cells in vitro, matching the performance of a leading competitor’s product. The company is now advancing this CAR into its innovative iNKT cell platform to tackle solid tumours.

Invex Therapeutics Ltd has had its trading suspension lifted following the announcement of a material acquisition, signaling a pivotal moment for the biotech company.

Starpharma has entered a strategic research and option agreement with Radiopharm Theranostics to develop a novel radiotherapy asset using its proprietary dendrimer technology, unlocking potential milestone payments of up to AUD $89 million.

Bio-Gene Technology Limited has addressed ASX concerns over the timing of its announcement on promising Flavocide efficacy data, confirming compliance with continuous disclosure rules after receiving final presentation materials from Purdue University.

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.