Catalyst Calendar

Interim efficacy data in rare paediatric neurological condition

First-in-human safety data for chlorotoxin CAR-T in glioblastoma

FDA review of OncoSil™ HDE application for distal cholangiocarcinoma is expected to be completed within approximately 45 days from the submission date of July 2, 2026. [Source: OncoSil Medical Files for FDA Approval, 2026-07-02]

H1 showed record revenue $124.8M (+28.4% YoY). Market watching for new contract announcements and margin trajectory

H1 revenue A$5.445B, EBITDA A$907M. Market expects further margin improvement

GTG has multiple outstanding periodic reports due by 29 August 2026. [Source: Long Term Suspended Entities, 2026-07-10]

Phase 2 progress for hernia repair indication

Market questioning whether $48M FY26 EBIT guidance is achievable

All 11 Technegas system installations across University Hospitals Cleveland network scheduled to be completed within weeks of the July 2026 agreement. [Source: Immediate 11-Site Technegas Rollout at University Hospitals, 2026-07-14]

Noxopharm expects to hold a pre-IND meeting with the US FDA within two months of the formal request to discuss the clinical development pathway for SOF-SKN™. [Source: Pre-IND meeting request with US FDA, 2026-07-06]

FDA assigned a PDUFA goal date of September 11, 2026 for the resubmitted NDA for TLX101-Px (Pixclara), a PET imaging agent for glioma characterization. [Source: FDA Accepts NDA for TLX101-Px (Pixclara), 2026-04-09]

Primary completion expected for NCT06125951. Indication: {"Dementia Moderate","Dementia, Mild","Alzheimer Disease"}

Registrational Phase III diagnostic trial in BCR prostate cancer. Enrolment target achieved March 2026, data expected H2 2026

Phase 3 data for hereditary angioedema prevention submitted to FDA

Rexlemestrocel-L in chronic heart failure, interim data expected

Data from Phase 2 DEP cabazitaxel trial in solid tumours

Multiple ascending dose cohorts ongoing; no safety issues to date; completion guides Phase II dose selection

Biosynthetic wound matrix clinical study top-line results

Formal commercial/manufacturing partnership terms expected to be announced. Medtronic holds 16.2% equity (US$90M, Jan 2026) with board observer rights.

First manufacturing runs for BZDS1901 expected in H2 2026 using plasmid DNA and mRNA transposases from Shanghai Cell Therapy Group. [Source: Second BZDS1901 milestone paid, 2026-06-30]

FDA pre-IND meeting anticipated in H2 2026 to advance BZDS1901 toward US clinical development. [Source: Second BZDS1901 milestone paid, 2026-06-30]

An IND amendment is being prepared to enable U.S. initiation of Part 2 of the ProstACT Global trial, following FDA alignment on the clinical protocol and safety monitoring plan. [Source: FDA Alignment to Advance ProstACT Global Phase 3 Trial, 2026-07-02]

Full results from the SNT-4728 Phase 2 trial in isolated REM Sleep Behaviour Disorder including digital and biological markers are expected in Q3 2026. [Source: Encouraging SNT-4728 Phase 2 iRBD results, 2026-07-05]

FDA-approved and launched in US/India. Further EU and Asia-Pacific geographic rollouts through CY2026

Management noted at H1 FY26 earnings call initial deployment could occur within months. Validates major TAM expansion beyond radiology

Formal FDA meeting to agree on Phase 3 design and endpoints. Could unlock Priority Review Voucher pathway (>US$150M)

In commercial discussions with leading clinical laboratories for EXO-OC and neuCA15-3

The multiple ascending dose (MAD) portion of the Phase I study is currently ongoing across two dose levels, with completion expected in Q3 2026. [Source: Update on Phase I Study of IMP761 for Autoimmune Diseases, 2026-03-18]

Interim analysis results evaluating the primary endpoint of change in weekly average of daily pain at Day 112 in the global Phase 3 PARA_OA_012 trial of injectable pentosan polysulfate sodium in knee osteoarthritis are expected. [Source: Paradigm Achieves 50% Patient Dosing in Phase 3, 2026-03-30]

Subject to HREC approval, first participant dosing in the bridging PK, safety and tolerability study is targeted for Q3 CY2026. [Source: Patrys advances RLS-2202 toward Phase 1 Clinical Trial, 2026-05-19]

Recruitment expected to accelerate from Q3 2026 as sites move to 24-hour Cath Lab-based drug storage and additional sites are activated. [Source: PROTECT-MI Phase IIa Clinical Trial Update, 2026-06-15]

Primary completion expected for NCT05485155. Indication: {"Eosinophilic Esophagitis"}

Primary completion expected for NCT07485582. Indication: {"Obstructive Sleep Apnea"}

Primary completion expected for NCT07081776. Indication: {COPD,"Respiratory Acidosis"}

GTG has a 2-year deadline of 21 October 2026 to execute plans for trading resumption or face removal from the official list. [Source: Long Term Suspended Entities, 2026-07-10]