Aravax Awarded FDA Fast Track Designation for PVX108

Melbourne, Australia and Oxford, UK – 3 August 2026, Aravax, a clinical-stagebiotechnology company developing next-generation, disease-modifyingimmunotherapies for food allergy, today announces it has received Fast Trackdesignation fromthe US Food and Drug Administration (FDA) for its lead product, PVX108for the treatment of peanut allergy. 

The FDA’s Fast Track programfacilitates the expedited development and review of new drugs or biologics thatare intended to treat serious or life-threatening conditions and demonstratethe potential to address unmet medical needs.

A drug that receives FastTrack designation is eligible for some or all of: more frequent meetings withthe FDA to discuss the drug’s development and collection of appropriate data;more frequent written communication with the FDA; eligibility for AcceleratedApproval and Priority Review if certain criteria are met; and Rolling Review,which means completed sections of the drug’s NDA can be submitted whencompleted rather than waiting until every section is completed.

“There remains a critical needfor effective new treatments for food allergy and we believe PVX108 has thepotential to offer a safer, more convenient and disease modifying treatment forthe millions affected by peanut allergy worldwide. Receiving FDA Fast Trackdesignation is a significant step for PVX108’s future development as being ableto communicate more frequently with the FDA often leads to early drug approvaland access by patients.”
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Dr Pascal Hickey, CEO of Aravax

PVX108 is a next-generation immunotherapy which uses proprietarypeptides designed to precisely retrain the immune system to tolerate peanut whilstavoiding treatment-induced acute allergic reactions.  Phase 2 studies of PVX108 are ongoing atclinics in the United States and Australia with key data anticipated to bereported later in 2026.

ENDS

About Aravax

Aravax is a clinical stage biotechnology companyfocused on revolutionising the treatment of food allergies withnext-generation, disease-modifying immunotherapies which are safer and moreconvenient than existing approaches.

Aravax’s proprietary platform generates peptidesdesigned to precisely retrain the immune system and restore the body’s abilityto safely tolerate food allergens, with minimal risk to patients of significanttreatment-induced acute allergic reactions, including anaphylaxis. The leadproduct, PVX108, is currently being studied in an international Phase 2 trialfor the treatment of peanut allergy. Uniquely, PVX108 has been designed to meetthe needs of all stakeholders managing peanut allergy. Aravax is also developinga pipeline of products to address additional food allergy indications.

Aravax is an international company with entities inMelbourne, Australia and Oxford, UK and operations in USA and Europe. Aravax’ssyndicate of leading international and Australian investors includes NovartisVenture Fund, Brandon Capital, Tenmile, Breakthrough Victoria, Uniseed andUniSuper.

For more information visit: www.aravax.com.au

For further information please contact

Media Contacts- Charles Consultants

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Chris Gardner E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077

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