Ascelia Pharma AB has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Orviglance, with the regulator requesting additional clinical data and product documentation before it can consider for approval.

The biotechnology company, which focuses on developing treatments for rare cancer conditions, said the FDA is currently unable to approve the application in its present form. The agency has asked the company to provide further clinical evidence and supporting product-related documentation as part of the review process.

In response, Ascelia Pharma said it plans to engage with the FDA to gain a detailed understanding of the issues raised in the Complete Response Letter and intends to request a Type A meeting with the regulator as soon as possible. The objective of the meeting will be to discuss the agency's concerns and identify the most efficient regulatory pathway for advancing the application.

Magnus Corfitzen, Chief Executive Officer, Orviglance, said the company remains confident in the potential of Orviglance and is committed to making the therapy available to patients. He added that Ascelia's immediate priority is to work closely with the FDA to establish an expedited path forward and that further updates will be provided as regulatory discussions progress.

Despite the regulatory setback, the company stated that its current financial position provides a cash runway into 2027. It also noted that it will evaluate potential cost-saving initiatives while continuing efforts to advance the programme.

Orviglance is one of two investigational drug candidates in Ascelia Pharma's oncology pipeline. The company's development portfolio also includes Oncoral, as it continues to focus on developing and commercialising therapies for orphan oncology indications that address significant unmet medical needs.