Subsequent Events

3 Months Ended

Mar. 31, 2024

Subsequent Events [Abstract]

Subsequent Events

Subsequent Events

SPN-830 Regulatory Development

In April 2024, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-830. The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. Prior to the issuance of the CRL, the Company submitted additional product quality data to the FDA, which it had not yet reviewed at the time of the CRL's issuance. The second relates to the master file for the infusion device, which is proprietary to the device manufacturer. No clinical safety or efficacy issues were identified as a requirement for approval.

The Company is in the process of analyzing the CRL and determining next steps for the resubmission of the NDA. While it is too early to ascertain the full impact to our financial statements, we may identify indicators of impairment for the related IPR&D asset, which represents an estimate of the fair value of SPN-830, resulting from the receipt of the CRL. Additionally, the Company also expects to assess adjustments to the fair value of the contingent consideration liabilities related to the milestone payments due upon the achievement of certain FDA regulatory approvals and the commercial launch of SPN-830. While we are unable to estimate the anticipated financial impact at this time, any potential adjustments would be recognized and reported within the second quarter of 2024. Any material adjustments to the fair value of the IPR&D asset or the fair value of contingent consideration liabilities could impact the Company’s results of operations and financial condition.