ILA to accelerate US government engagement for Marburg drug
Our 2025 biotech Pick Of The Year Island Pharmaceuticals (ASX: ILA) is increasing US government engagement for its Marburg disease drug Galidesivir….
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).
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).
On Monday ILA received approvals to utilise the “Animal Rule” pathway and is now seeking FDA feedback on a trial design before submissions for approvals…
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
In Monday’s announcement ILA said “These include negotiations with…, as well as US
government engagement initiatives.”.
(Source)
Today, ILA appointed Todd Strategy Group (TSG) to strengthen ILA’s positioning in the US biodefence and health security landscape.
TSG is a Washington DC based government affairs firm, which will help ILA accelerate engagement with the US government to advance its antiviral programs.
The collaboration will have a focus on informing ILA on government priorities and also to help identify potential non-dilutive funding opportunities.
These include:
- Strategic guidance on federal processes, agency activities, and congressional considerations.
- Support with the broader medical countermeasure enterprise.
- Ensures ILA remains well-informed as its programs progress.
- Help ILA stay appropriately positioned amid evolving US Government priorities.
- Focusing on areas to include emerging infectious disease threats.
ILA research coverage since the Animal Rule news
We first Invested in ILA back in May this year, our Initial Entry Price was 15c per share.
On Monday, after the Animal Rule news, we made ILA our 2025 Biotech Pick Of The Year.
Since that announcement, we have seen research get published that is putting price targets on ILA above $1 per share.
(It’s always good to see one of our Portfolio stocks grow into a company that is being covered by more analysts and being picked up by more institutional groups)
Here is the research piece we saw from RaaS which had a price target of A$1.14 on ILA:
(Source)
AND here is a note circulated by the Prenzler Group:
(Source)
What’s next for ILA in the next 6-9 months
Today: ILA confirms 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
