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Occurring Fact4582SymBio Pharmaceuticals LimitedPharmaceuticals

NIH-led clinical trial of IV BCV for progressive multifocal leukoencephalopathy completes patient enrollment (FPI)

Completed first-patient enrollment in an NIH/NINDS-led clinical trial of intravenous brincidofovir (IV BCV) for progressive multifocal leukoencephalopathy (PML).

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Completed first-patient enrollment (FPI) in an NIH-led IV BCV clinical trial for progressive multifocal leukoencephalopathy

Subject Entity

SymBio Pharmaceuticals Limited and the National Institute of Neurological Disorders and Stroke (NINDS) within the U.S. National Institutes of Health (NIH)

Target Locations / Products

NIH Clinical Center (Bethesda, Maryland), intravenous brincidofovir (IV BCV), and patients with progressive multifocal leukoencephalopathy (PML)

This disclosure06/09/2026
Amount of Impact on Business Performance

No amount disclosed. There is no impact on the earnings forecast for the fiscal year ending December 2026.

Impact on Earnings Forecast

This matter will have no impact on the earnings forecast for the fiscal year ending December 2026.

Related procedures

Type

Investigator-initiated clinical trial

Court or authority

U.S. National Institutes of Health (NIH) and National Institute of Neurological Disorders and Stroke (NINDS)

Outlook

The company will advance development for PML and multiple sclerosis together with NIH/NINDS and expand its business in the field of neurodegenerative diseases.

Event that occurred
ItemDetails
Event nameCompleted first-patient enrollment (FPI) in an NIH-led IV BCV clinical trial for progressive multifocal leukoencephalopathy
Subject EntitySymBio Pharmaceuticals Limited and the National Institute of Neurological Disorders and Stroke (NINDS) within the U.S. National Institutes of Health (NIH)
Target Locations / ProductsNIH Clinical Center (Bethesda, Maryland), intravenous brincidofovir (IV BCV), and patients with progressive multifocal leukoencephalopathy (PML)
Amount of Impact on Business PerformanceNo amount disclosed. There is no impact on the earnings forecast for the fiscal year ending December 2026.
Impact on Earnings ForecastThis matter will have no impact on the earnings forecast for the fiscal year ending December 2026.
Type of litigation or proceedingInvestigator-initiated clinical trial
Court or authorityU.S. National Institutes of Health (NIH) and National Institute of Neurological Disorders and Stroke (NINDS)
OutlookThe company will advance development for PML and multiple sclerosis together with NIH/NINDS and expand its business in the field of neurodegenerative diseases.
Items this document does not state (17)
Date of occurrenceDate recognized / date notice receivedCauseAccounting period in which recognizedPlaintiffDefendantDate of filing / date of actionClaim amount / surcharge amountAmount of receivables at risk of non-collection or delayed collectionSuspended operationsScheduled resumption dateInvestigation structureMeasures to prevent recurrenceDirectors' and officers' liabilityVoting rights ownership percentage before the changeVoting rights ownership percentage after the changePlanned follow-up disclosure

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The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The company states that the trial is being conducted to evaluate the efficacy and safety of IV BCV for PML and build clinical knowledge.

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NIH-led clinical trial of IV BCV for progressive multifocal leukoencephalopathy completes patient enrollment (FPI) | SymBio Pharmaceuticals Limited (4582) timely disclosure | Komori