Island Pharmaceuticals Ltd (ASX:ILA) is an antiviral therapeutics company targeting infectious diseases. The company announced on 4 February 2026 that it had received anticipated feedback from the US Food & Drug Administration (FDA) on how to progress Galidesivir toward FDA approval under the Animal Rule Pathway. Crucially, the FDA has provided clear regulatory alignment on variables that were previously unknown. This is a further de-risking event for ILA as no more clarifying questions are required, and ILA can progress with defined steps towards demonstrating efficacy of Galidesivir on Marburg. In what will now be a two-stage clinical development pathway, pivotal study efficacy results are likely due in late-2026 (vs the previous best-case scenario of mid-2026). While a slight delay, the two-stage pathway should result in a better defined and smaller pivotal study which potentially increases the probability of success. Pharmacology results from Stage 1 studies will likely be in the June quarter, providing for important news flow in the near term. Separately, ILA also announced that it had raised $9m at $0.35/share in a placement. With an estimated ~$15.4m in cash, ILA is fully funded to complete its Galidesivir programme and make its New Drug Application (NDA) submission. The company continues to progress in an impressive and thoughtful way, potentially becoming the first Australian biotech to deliver a drug via the Animal Rule pathway which would save several years in the development process. Our probability-weighted NPV (rNPV) moves to $1.24/share from $1.14/share previously.
05 Feb 2026
Fully funded with regulatory clarity
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Fully funded with regulatory clarity
Island Pharmaceuticals Ltd (ILA:ASX) | 0 0 0.0%
- Published:
05 Feb 2026 -
Author:
Naheed Rahman -
Pages:
6 -
Island Pharmaceuticals Ltd (ASX:ILA) is an antiviral therapeutics company targeting infectious diseases. The company announced on 4 February 2026 that it had received anticipated feedback from the US Food & Drug Administration (FDA) on how to progress Galidesivir toward FDA approval under the Animal Rule Pathway. Crucially, the FDA has provided clear regulatory alignment on variables that were previously unknown. This is a further de-risking event for ILA as no more clarifying questions are required, and ILA can progress with defined steps towards demonstrating efficacy of Galidesivir on Marburg. In what will now be a two-stage clinical development pathway, pivotal study efficacy results are likely due in late-2026 (vs the previous best-case scenario of mid-2026). While a slight delay, the two-stage pathway should result in a better defined and smaller pivotal study which potentially increases the probability of success. Pharmacology results from Stage 1 studies will likely be in the June quarter, providing for important news flow in the near term. Separately, ILA also announced that it had raised $9m at $0.35/share in a placement. With an estimated ~$15.4m in cash, ILA is fully funded to complete its Galidesivir programme and make its New Drug Application (NDA) submission. The company continues to progress in an impressive and thoughtful way, potentially becoming the first Australian biotech to deliver a drug via the Animal Rule pathway which would save several years in the development process. Our probability-weighted NPV (rNPV) moves to $1.24/share from $1.14/share previously.