ILA completes follow up submission to FDA
Our 2025 biotech Pick Of The Year Island Pharmaceuticals (ASX: ILA) just made an additional submission to the FDA.
These are responses relating to guidance received from the FDA, where it recently received approval to utilise the animal rule pathway, when we made ILA our 2025 Biotech Pick of the Year.
ILA expects to hear back on or before the 2nd of January 2026, US time.
With this, ILA will hear more on the specific development program that its Marburg drug Galidesivir will be taking under the animal rule, so will allow ILA to gain more clarity on the process going forward.
As part of this process, ILA had the opportunity to ask questions and seek clarifications, so can now wait for a response ahead of what is shaping up to be a big next year.
ILA is looking to develop Galidesivir as an antiviral drug aimed at treating Marburg disease.
Marburg virus is classified as a Category A bioterrorism threat (the highest level threat) by the US government (source).
ILA recently got approved for a fast tracking avenue utilising the “Animal Rule” and a valuable Priority Review Voucher.
This allows ILA to effectively skip a 15+ year, expensive process of human phase 2 & 3 clinical trials.
Marburg is the only Category A biothreat with no current vaccine or FDA approved treatment…
It's also one of the most deadly with a fatality rate up to 88%.
It’s classified as a biothreat because it can be weaponised (and it was part of the soviet bioweapons program in the 80’s,(source, source).
ILA is going for approvals on the drug via a fast tracked “Animal Rule” approvals pathway - which is basically where biotech’s can seek FDA approvals for really deadly diseases on animal trials alone.
(Cutting out the 10-15 years of human trials needed for most drugs).
We are Invested in ILA to see it go through the animal rule process - get its drug FDA approved (fingers crossed).
Approvals for ILA (potentially inside the next 12-18 months) could unlock:
- A Priority Review Voucher (PRV) that comes in if ILA’s Galidesivir is FDA approved - these can be worth on average ~US$150M.
- US Government national stockpiling deals - these can be worth anything between US$100M to US$1.2BN ANNUALLY
We covered all of this in our most recent note here: ILA: Our Biotech Pick of the Year
What’s next for ILA in the next ~6 months
Mid November: ILA confirmed Animal Rule eligibility for its Marburg drug ✅
NEXT: FDA confirms to ILA the use of the Animal Rule for its Marbourg disease treatment and PRV voucher eligibility successful.
NEXT: Commence animal trial for deadly Marburg disease. Here are the milestones we will be tracking for the animal study:
- 🔲 Clinical trial design completed
- 🔲 Clinical trial starts
- 🔲 Clinical trial completed
- 🔲 Clinical trial results
NEXT: (Assuming results are good) Submit to FDA for commercial approval and access to Priority Review Voucher
