Here are 4 ASX biotechs with major milestones coming right up!

Investing in ASX biotechs is a risky business, even more than most other companies on the market. Unless you own one of the large cap biotechs, you are betting that major milestones (such as clinical trial completions and decisions on regulatory approval) will occur right on cue and that they will be favourable to the company.

But it doesn’t hurt to know which companies have these milestones upcoming, because at least you’ll get an answer sooner. Here are 4 ASX biotechs with major milestones coming up soon.

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4 ASX biotechs with major milestones coming right up!

1. Imagion Biosystems (ASX:IBX)

Imagion’s focus is on its MagSense® molecular MRI imaging agent. An imaging agent is administered to the body and makes certain things in the body easier to say. In the case of MagSense, it targets HER2 biomarkers with iron‑oxide nanoparticles that show up strongly on MRI.

After successfully completing Phase 1 safety studies, the company progressed into preparatory work for a Phase 2 program in HER2‑positive breast cancer, including manufacturing of a new batch of the imaging agent under FDA‑style Good Manufacturing Practice and optimisation of imaging protocols in collaboration with Siemens Healthineers and Wayne State University.

These steps were critical inputs to the Investigational New Drug (IND) application lodged with the U.S. Food and Drug Administration in early Feb 2026, paving the way for a Phase 2 trial expected to start as early as Q1 2026 pending FDA clearance.

Filing the IND is earlier stage than getting clinical trial results, but it is still a major regulatory milestone validating the scientific and regulatory foundation of MagSense. Enrolment for the Phase 2 clinical trial will be closely watched for early diagnostic performance data after trial initiation

2. Clarity Pharmaceuticals (ASX:CU6)

Sticking with imaging agent-focused company here, Clarity’s technology is Targeted Copper Theranostics (TCT). Its technology platform has a bifunctional chelator (cage) at its heart that can bind and retain the copper isotopes used (in other words, stop them leaking into the body before reaching the cancer cells and causing damage to healthy cells).

Clarity is progressing two registrational Phase III trials — the AMPLIFY (for biochemical recurrence) and CLARIFY (pre‑prostatectomy) studies — with first patient imaging achieved and active recruitment across US and Australian sites.

Full enrolment of CLARIFY is expected in H1 CY2026 and potential New Drug Application (NDA) planning underway for post‑trial data submission. Additionally, clinical data from the Co‑PSMA study has been accepted for presentation at the 2026 European Association of Urology Congress, adding to the evidence base ahead of later‑stage readouts.

3. Cynata Therapeutics (ASX:CYP)

Cynata is advancing its proprietary Cymerus™ induced pluripotent stem cell (iPSC‑derived) mesenchymal stromal cell therapies, with its lead candidate CYP‑004 positioned as a disease‑modifying therapy for knee osteoarthritis. The pivotal Phase III SCUlpTOR trial, run in collaboration with the University of Sydney and funded by an Australian NHMRC grant, completed all final patient visits in late 2025, entering data verification and analysis phases.

Top‑line results from this trial are expected in Q2 2026, which could be transformational if they demonstrate both symptomatic relief and structural benefit. Alongside CYP‑004, Cynata is preparing for clinical readouts in its Phase 2 acute graft‑versus‑host disease (aGvHD) study of CYP‑001, and management has highlighted 2026 as a pivotal year transitioning the company into late‑stage clinical validation with potential regulatory discussions to follow positive outcomes.

4. Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals (ASX: PAR) is developing injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis (OA), targeting both pain and underlying disease progression. Its global Phase III PARA_OA_012 trial is actively recruiting across Australia, the United States, Hong Kong and Moldova, with the majority of clinical sites now operational and 25% recruitment achieved in late 2025.

Paradigm expects full enrolment of ~466 participants during 2026, with an interim analysis planned for mid‑2026 once ≥50% of participants reach Day 112 of treatment — a key near‑term value catalyst. The trial’s primary endpoint is change in average daily pain, with secondary outcomes including functional scores and imaging biomarkers.

Imagion Biosystems is a research client of Pitt Street Research. Pitt Street directors own shares in Imagion.