5 ASX Healthcare Companies with Game Changing Milestones in 2026!

2026 is set to be a big year for several ASX Healthcare Companies, especially companies in the pre-commercialisation stage. The two keys to get drugs or devices to market are to pass clinical trials and obtain regulatory approval. This article takes a look at 5 of the most exciting of those companies.

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5 ASX Healthcare Companies with Game Changing Milestones in 2026!

Dimerix (ASX:DXB)

Dimerix is in Phase 3 clinical development with DMX-200, for an Orphan kidney disease called Focal Segmental Glomerulosclerosis (FSGS). Even though the trial will continue into 2027, it is possible the company could get approval in 2026, depending on how interim data from Part 2 of the trial turns out. The endpoint of the trial is the extent of proteinuria in the urine and the company may be able to obtain approval based off an effect after 52 weeks and this could be later this year.

If the preferred endpoints have been achieved at the 52 week mark, Dimerix can then proceed to file for FDA approval of Qytovra. Even if the milestone of a green light is delayed to early 2027, the confirmation of the data and whether or not a 52 week mark is acceptable will be milestones in themselves.

Blinklab (ASX:BB1)

BlinkLab has an e-platform that can help diagnose neurological disorders in children such as ADHD and autism. It is a formal diagnosis – not a general subjective judgement. The device consists of a mobile app to collect Data and a Portal to analyse the data and to customise the tests. Although it is not yet FDA approved, BlinkLab has completed roughly 6,000 individual tests.

This year, Blinklab will undertake a clinical trial, examining the ability of the app to diagnose autism in children between 2 and 6 years of age. All the while, the company will lay the groundwork for a commercial launch, including seeking reimbursement code and support from Key Opinion Leaders. The company reckons regulatory approval can come in the second half of this year.

Actinogen (ASX:ACW)

ACW has a drug called Xanamem which it is using to fight neurological disorders, in particular Alzheimer’s where the drug is in a Phase 2b/3 trial. Interim analysis will come out in January and the final results will be in Q4. The company is looking for disease-modifying effects in Alzheimers, by controlling 11beta-HSD1.

The company is also ready for a Phase 2a trial in Fragile X syndrome and has plans to address other indications including PTSD and bipolar disorder down the track, but the Alzheimers trial is key right now.

Clarity Pharmaceuticals (ASX:CU6)

Clarity is aspiring to follow in the footsteps of Telix by commercialising a cancer imaging agent. One of Clarity’s agents is 64Cu-SAR-bisPSMA, a PET-imaging agent for prostate cancer which is in the middle of two ongoing Phase III registrational trials (CLARIFY and AMPLIFY). Data from these trials are intended to support a New Drug Application (NDA) in the U.S.

Clarity is already poised to hit the market in possessing multiple Fast Track Designations from the U.S. FDA for its SAR-bisPSMA products — this accelerates development and review and allows rolling NDA submissions, not to mention having a manufacturing agreement with SpectronRx.

Recce Pharmaceuticals (ASX:RCE)

Recce is developing R327 for ‘superbugs’ and conditions they cause such as diabetic foot infections and acute bacterial skin infections. Recce has commenced a registrational Phase III trial of R327G in Indonesia — this is designed to support regulatory approval by Indonesia’s Drug and Food Authority (Badan POM) and potentially broaden to ASEAN markets that will accept a green light from Indonesia’s authorities as evidence it is safe and efficacious to warrant being permitted in their markets.

Recce will likely need further trials to warrant approval in the West. Nonetheless, it has trials underway in other indications, especially for ABSSSI.