Latest Drug Development News

Immutep Limited has confirmed 30 mg as the optimal biological dose for its immunotherapy efti, following FDA approval of Project Optimus requirements. This milestone paves the way for the US launch of its pivotal Phase III lung cancer trial.

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.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Opthea Limited has received a substantial A$10.8 million R&D tax incentive from the Australian government, reinforcing its commitment to advancing its novel drug candidate sozinibercept. This funding milestone underscores the company’s strategic focus on innovation and fiscal discipline.

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.

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.

Recce Pharmaceuticals has initiated patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, targeting a significant market with high diabetes prevalence. Interim results expected in early 2026 could accelerate regulatory approval and commercial launch.

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.

Algorae Pharmaceuticals has secured an exclusive licensing agreement with Sakar Healthcare to introduce five generic oncology medicines in Australia and New Zealand, marking its first commercial foray in the region.

INOVIQ Limited has demonstrated that its CAR-NK-exosome therapy kills over 90% of triple-negative breast cancer cells within 10 hours in laboratory tests, validating its potential as a next-generation cancer treatment.

Starpharma has entered a significant collaboration with Genentech to develop dendrimer-drug conjugates for oncology, securing an upfront payment and potential milestone earnings exceeding half a billion dollars.

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.