Notice of IRB Approval for the Domestic Phase 3 Clinical Trial of the Achondroplasia Treatment umedaptanib pegol

IRB approval has been obtained at one of the participating medical institutions for the domestic Phase 3 clinical trial of umedaptanib pegol in pediatric patients with achondroplasia. The company has now moved into the stage of obtaining approval at each participating institution and preparing for first patient enrollment.

Worth reading

55In focus

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Direction

Improvement

Direction inferred from the company’s description.

Scale

Target number of subjects

Wording

Conditional

How definitive the wording is.

Announced details

umedaptanib pegol (RBM-007, anti-FGF2 aptamer)

Applicable field (uses covered by this announcement)

Clinical trial of a treatment for pediatric patients with achondroplasia (ACH) aged 2–14 years

Impact on Business Performance

No change to the full-year earnings forecast for the fiscal year ending March 2027

The company does not address Contract Value / Offering price.

Announced details
Item	Details
Names of Products / Services Covered	umedaptanib pegol (RBM-007, anti-FGF2 aptamer)
Applicable area	Clinical trial of a treatment for pediatric patients with achondroplasia (ACH) aged 2–14 years
Impact on Business Performance	No change to the full-year earnings forecast for the fiscal year ending March 2027

Items this document does not state (15)

CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historySource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

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

To move into the final preparations for first patient enrollment (FPI) in the trial and begin subject enrollment as soon as possible.

How to read this page

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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.