Latest Therapeutics News

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

Nexalis Therapeutics has ended funding negotiations with Point8 Capital after failing to secure a formal agreement, while successfully completing its IRX-616a Phase 1 trial with no serious adverse events. The company is reassessing clinical priorities amid funding uncertainty.

Starpharma has reached a key milestone in its collaboration with Radiopharm Theranostics, unlocking a $0.5 million option fee and advancing the partnership toward a potential $91 million licensing deal.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.

Neurotech International has received Notices of Allowance from the USPTO for two patents covering its lead drug NTI164, reinforcing its intellectual property position as it advances Phase 3 trials for autism spectrum disorder.

Imugene reports a second complete response in its Phase 1b trial of azer-cel combined with BTK inhibitors, including the first patient with Mantle Cell Lymphoma who had failed prior BTKi therapy.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Chimeric Therapeutics has appointed Hawkesbury Partners to lead a strategic review aimed at exploring options to enhance shareholder value, reflecting concerns that its market cap undervalues its clinical assets and infrastructure.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

Skin Elements Limited has secured a $900,000 placement at a 25% discount to recent prices, bolstering its balance sheet to advance its natural biotechnology product range. The company also appointed Rod Nicholas as non-executive chairman and engaged Phoenix Global Investments for investor relations.