Seikagaku Corporation
Receipt of Completion Notice for Examination Regarding US Approval Application of lumbar disc herniation treatment SI-6603
We have received a Complete Response Letter (CRL) from the U.S. FDA regarding the approval application of SI-6603 for lumbar disc herniation treatment. There are no concerns about drug efficacy or safety; no additional clinical trials are required, but deficiencies in the manufacturing contractor led to the approval denial. We will consider resubmission in collaboration with licensing partner Felling Pharmaceuticals. Impact on the consolidated results for the fiscal year ending March 2027 is undecided.
Key Figures
- Resubmission timing: Unknown
- Reason for CRL: deficiencies at the API/finished drug manufacturing contractor
- Clinical data assessment: no efficacy/safety concerns, no additional clinical trials required
AI要約
Neutral headline
This release announces that we have received a Complete Response Letter (CRL) from the FDA regarding the US approval application for SI-6603. The CRL mainly stems from findings at the API manufacturing facility and deficiencies identified during the cGMP inspection of a newly contracted finished drug manufacturer. There are no concerns about the efficacy or safety of the clinical data, and no additional clinical trials are required. We will proceed with the resubmission plan in collaboration with the licensee Felling Pharmaceuticals.
Financial outlook and future prospects
The impact of this matter on the consolidated earnings forecast for the fiscal year ending March 2027 is currently under review, and we will disclose promptly if there are any material items. As of now, specific numerical impacts are unknown, and we are pursuing a cautious disclosure approach.
Seikagaku Corporation
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