Latest Clinical Trials News

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

Racura Oncology has locked in an underwriting agreement covering nearly 1.84 million expiring options, ensuring up to $2.3 million in fresh capital to back its cancer drug development programs.

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.

Actinogen Medical has obtained positive scientific advice from the European Medicines Agency that aligns with prior FDA guidance, clarifying regulatory requirements for its Alzheimer’s drug Xanamem and paving the way for a streamlined approval process in major markets.

Nexalis Therapeutics has locked in a $53 million non-dilutive funding facility with Point8 Capital, replacing its previous lender and supporting three clinical programs targeting breakthrough cancer pain, panic disorder, and treatment-resistant depression.

Imugene has dosed the first patient in a new cohort combining its azer-cel CAR T therapy with BTK inhibitors, targeting patients with B-cell malignancies who failed prior BTKi treatment. This move broadens the trial’s scope and tackles a significant unmet need in blood cancer therapy.

Tetratherix Limited secures $15 million via institutional placement plus a capped $2 million share purchase plan at a 14% discount, aiming to fast-track manufacturing expansion and commercial partnerships.

OncoSil Medical has secured a pivotal ethics committee approval in Italy, reclassifying its OSPRItaly registry and enabling a streamlined procurement process that could double the number of authorised hospitals using its OncoSil™ device by mid-2027.

Acrux has amended its licensing agreement with Gedeon Richter to bring its Estradiol spray Lenzetto® to Australia, unlocking up to AUD 5.4 million in milestone payments and addressing a critical shortage in Menopause Hormone Therapy products.

Neuren Pharmaceuticals reported a 15% rise in 2025 royalties from DAYBUE®, boosted by strong US sales and a new powder formulation launch. The company is progressing its pivotal Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome and reassessing capital management amid solid cash reserves.

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Neurizon Therapeutics has boosted the participant count in its HEALEY ALS Platform Trial Regimen I from 160 to 240, capitalising on faster enrolment and philanthropic support to maintain costs and accelerate topline results to early Q3 2027.