Seikagaku receives FDA complete response letter for SI-6603 on manufacturing deficiencies

Reuters2026/09/10 07:05

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FDA issued a complete response letter on Seikagaku’s U.S. BLA for SI-6603 (condoliase), blocking approval in its current form.
cGMP deficiencies remained at the drug substance site; new issues emerged at the contract drug product manufacturer, requiring remediation.
FDA raised no clinical efficacy or safety concerns; no additional clinical studies were requested.
Management is working with the FDA and partner Ferring to prepare a prompt resubmission.
Seikagaku is assessing the impact on its fiscal year ending March 31, 2027 outlook.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seikagaku Corporation published the original content used to generate this news brief on September 10, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Seikagaku receives FDA complete response letter for SI-6603 on manufacturing deficiencies

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