Latest Clinical Development News

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.

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.

(E,E)-bisantrene, Race Oncology’s lead anticancer candidate, operates by binding to G4-DNA and RNA structures, revealing a novel mechanism that disrupts key cancer drivers including the MYC gene.

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.

Syntara Limited has reported positive final data from its Phase 2a trial of amsulostat in myelofibrosis, demonstrating significant symptom relief and spleen volume reduction with a favorable safety profile. These results pave the way for advancing clinical development and partnership discussions.

Syntara Limited has reported encouraging Phase 2a results for amsulostat combined with ruxolitinib in treating myelofibrosis, demonstrating sustained symptom improvement and spleen volume reduction over 52 weeks.

Imagion Biosystems has completed the second tranche of its $3.5 million placement, raising $2.85 million to advance its proprietary MagSense® imaging technology targeting breast, prostate, and ovarian cancers.

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.

Noxopharm Limited has secured an extension on $2.6 million of convertible notes and obtained a $1.25 million unsecured loan to bolster working capital, pending shareholder approval.

Starpharma has entered a landmark collaboration with Genentech to develop innovative cancer therapies using its proprietary DEP® platform, securing $5.5 million upfront and potential milestones exceeding $560 million.

PYC Therapeutics has restructured its Board and executive team to steer the company through pivotal clinical milestones expected by the end of 2027. The changes signal a strategic push toward late-stage development of its RNA-based drug candidates.

CLINUVEL Pharmaceuticals has presented compelling new case studies demonstrating the efficacy of SCENESSE® in treating vitiligo, showing significant and stable repigmentation in patients. These findings, shared at the EADV conference, hint at a potential breakthrough for a condition with limited treatment options.