Latest Biotechnology News

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.

Zoono Group has secured its first major commercial orders worth NZ$600,000 from Sharpak under an exclusive UK soft fruits packaging contract, marking a key step in scaling its antimicrobial coating technology in international markets.

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.

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.

Biome Australia has launched a multi-centre clinical trial for its proprietary probiotic BMB18, adding a prestigious Greek university to its research network and commencing recruitment within the expected timeline.

Skin Elements Limited has lodged an application with the Takeovers Panel alleging undisclosed voting power exceeding 20% via a private placement, raising questions about shareholder rights ahead of critical board spill meetings.

Nexalis Therapeutics (ASX: NX1) has voluntarily suspended trading of its shares pending a material announcement on its existing debt funding facility, extending a recent trading halt. The suspension is set to last until the earlier of the announcement release or resumption of trading on 28 May 2026.

Noxopharm has unveiled new data showing its Sofra technology dramatically boosts TLR8 activation, a key immune pathway, potentially reshaping cancer immunotherapy.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.