Biotech Dispatch

FDA backs NeuroScientific's stem cell trial for hard to treat Crohn's disease

Regulators have favourably answered most of the biotech's questions ahead of a planned mid-stage stem cell therapy trial, with one manufacturing concern still to resolve before the study can start.

dorsaVi says its human movement data is an asset robot makers want

Wearable sensor maker dorsaVi has raised $3 million via a share placement to grow its movement data library for humanoid robotics developers and advance its neuromorphic and semiconductor chip programs.

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Neurizon hands the reins to Chris Bremer as ALS trial heads for critical readout

Neurizon Therapeutics appoints Chris Bremer as CEO while interim executive chairman Sergio Duchini becomes non-executive chairman, with the company's ALS drug awaiting Phase 2/3 trial results in 2027.

Paradigm Biopharmaceuticals enters voluntary administration after Phase 3 setback

Melbourne biotech Paradigm Biopharmaceuticals appointed FTI Consulting administrators after its Phase 3 trial failed an interim efficacy threshold, and now seeks to restructure debts via a deed of company arrangement.

Telix announces takeover of ITM to create a global radiopharmaceutical powerhouse

Telix Pharmaceuticals has agreed to merge with German isotope producer ITM in a US$1.65 billion upfront deal, with contingent payments of up to US$700 million, creating a combined radiopharmaceutical group.

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Paradigm hands medical reins to rheumatology specialist as Phase 3 data looms

Biotech Paradigm Biopharmaceuticals appoints rheumatology specialist Daniel Furtner as chief medical officer; predecessor Donna Skerrett stays as senior scientific advisor, and the firm's late-stage osteoarthritis trial has finished enrolling 538 participants.

FDA clears Telix's Pixclara as the world's first approved brain cancer imaging drug

Telix Pharmaceuticals has gained US regulatory clearance for its glioma imaging agent Pixclara, a world first, and is now studying the compound in late-stage trials for brain metastases.

US health agency funds broad access trial for Melbourne biotech's ALS drug

America's NIH has agreed to fund a program giving up to 200 ALS patients access to Neurizon Therapeutics' drug NUZ-001, with Melbourne-based Neurizon as subawardee and a Boston ALS centre running it.

OncoSil marks a milestone moment for pancreatic cancer patients in Spain

OncoSil Medical says a Madrid hospital has treated its 100th Spanish pancreatic cancer patient with its brachytherapy device, as the ASX-listed company focuses on deepening use across its 11 treatment sites.

OncoSil Medical wins major investor backing to take its cancer device global

OncoSil Medical has raised $5.6m from three large existing shareholders to fund overseas and domestic launches of its radiation therapy, after winning TGA and FDA clearances for pancreatic and bile duct cancer use.

Neurizon Therapeutics appoints Chris Bremer as chief executive to steer ALS drug through final trial stage

Neurizon Therapeutics, a Melbourne biotech developing an ALS treatment, has appointed industry veteran Dr Chris Bremer as CEO as its lead drug NUZ-001 heads toward Phase 2/3 trial results in 2027.

Arovella Therapeutics moves 'off-the-shelf' cell therapy from lab to patients

Arovella Therapeutics has produced its first clinical batch of ALA-101, a donor-derived cell therapy for blood cancer, and begun trials at a Melbourne hospital, with the first patient expected to be dosed this month.

ENA Respiratory secures funding to test antiviral nasal spray in people with asthma

Melbourne biotech ENA Respiratory has received $2.98 million from incubator Biointelect Venturer's first investment round, one of six companies backed, funding a Phase Ib asthma study of its INNA-051 antiviral nasal spray.

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Percheron raises $2.3 million to fully fund Vanderbilt AML trial

Melbourne biotech Percheron Therapeutics has locked in $2.3 million through an institutional placement to fund a Vanderbilt Health trial of its HMBD-002 antibody in blood cancers.

Six Australian infectious disease ventures share $10.48 million in funding round

An Australian infectious-disease incubator has selected six local biotechs to divide $10.48 million from its inaugural funding round, pairing non-dilutive cash with commercialisation support; the program is backed by an earlier MRFF grant.

Alterity secures option underwriting as it prepares for pivotal MSA trial

Alterity Therapeutics has appointed MST Financial Services to backstop its expiring listed options ahead of a pivotal Phase 3 trial of its lead drug candidate for a rare neurodegenerative disorder.

Mesoblast revenue surges as Ryoncil gains ground and back pain trial reaches key milestone

Mesoblast's yearly report shows revenue leaping on first-year American sales of Ryoncil, losses narrowing, and a US$125 million debt refinancing, with its spinal disc trial fully recruited ahead of 2027 data.

Entropy takes TRP-8803 to the US in head-to-head depression trial

Entropy Neurodynamics has agreed with UCSF to run a US Phase 2 trial of its psilocin drug TRP-8803 against escitalopram in young adults with depression, pending FDA clearance, with Swinburne and BioCina supporting.

Starpharma narrows loss as Genentech deal lifts revenue and new funding extends runway

Melbourne biotech Starpharma grew annual revenue on a Genentech licence payment, cut its loss, and completed a $30 million entitlement offer, giving it cash into 2028 to advance its cancer pipeline.

Genetic Signatures and Microba explore merger to build infectious disease diagnostics group

The two diagnostics companies have entered early-stage merger talks aiming to combine rapid pathogen testing with gut microbiome analysis, though both stress the discussions are preliminary with no terms agreed.

Neuren secures European approval for Rett syndrome treatment

European regulators have cleared Neuren's Rett syndrome drug DAYBU, the first such treatment authorised in the EU, with milestone payments due to the Melbourne biotech from licence partner Acadia.

Acrux brings experienced clinical leader aboard to advance testosterone program

Acrux has hired Dr Jolanta Airey as chief medical officer, adding clinical leadership as the company prepares late-stage trials in the United States for its women's testosterone therapy.

Avecho moves to deepen global partnering push as CBD insomnia program advances

Avecho Biotechnology brings in a former CSL dealmaking executive as a consultant to help license its Phase 3 CBD insomnia capsule internationally.

Mesoblast completes treatment in pivotal low back pain trial as phase 3 readout approaches

Mesoblast has finished dosing all 350 patients in its phase 3 trial of rexlemestrocel-L for degenerative disc disease, with data due mid-2027 and a possible US biologics application to follow.

OncoSil secures FDA approval for targeted bile duct cancer device

Australian device maker OncoSil Medical has won US FDA humanitarian exemption approval for its targeted radiation treatment for unresectable distal bile duct cancer, opening a path to American commercialisation in financial year 2027.

Biotron advances hepatitis B candidate towards human trials after promising HBV and HDV results

Sydney biotech Biotron reports lab results showing its hepatitis B drug candidate works against HBV and HDV, and will begin formal preclinical studies ahead of planned human trials in 2027.

CUREator+ backs six Australian startups with $13.5 million to advance new health technologies

Six Australian health tech startups received a combined $13.5 million in non-dilutive funding from the CUREator+ program, supported by the Australian Government.

Starpharma completes $32 million entitlement offer with near full shareholder take-up

Starpharma wrapped up its $32 million shareholder rights issue with roughly 99% participation, with proceeds earmarked for first-in-human testing of its DEP HER2-Lutetium cancer therapy.

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Percheron turns to former Arovella chief Michael Baker for next phase of HMBD-002 development

Percheron Therapeutics has appointed Arovella Therapeutics' former leader Michael Baker as CEO from October, with James Garner departing for an overseas role while joining the board as a non-executive director.

Starpharma raises $32 million to advance dendrimer cancer programs

Starpharma has launched a shareholder entitlement offer of about A$32 million, underwritten by Canaccord Genuity, to fund a Phase 1 cancer study and broaden its dendrimer oncology pipeline.

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Ferronova secures funding to advance nanoparticle technology for cancer surgery

Adelaide medtech Ferronova added $6 million to its Series A for image-guided cancer surgery, led by Uniseed/UniSuper, South Australian Venture Capital Fund, Artesian and Renew Pharmaceuticals; Renew's parent UltraGreen.ai recently listed in Singapore.

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