By Joe Hoppe

Clinigen Group PLC said Wednesday that the U.S. Food and Drug Administration has issued a complete response letter to its partner Porton Biopharma Ltd., rejecting its leukemia treatment license application in its current form.

The pharmaceutical services and products company said Porton is in the process of reviewing the letter and will provide it updates as soon as discussions with the FDA have been completed.

The company signed a global licensing and distribution agreement with Porton in April 2020 to commercialize and distribute Erwinaze, an acute lymphoblastic leukemia treatment designed for patients who have developed hypersensitivity to E. coli-derived treatments. Clinigen supplies Erwinaze to more than 30 licensed and unlicensed markets outside the U.S.

Given that the company has recently negotiated more favorable terms with Porton, cost-savings linked to the delayed rollout of Erwinaze in the U.S. and its strong pipeline, Clinigen maintained its fiscal 2022 guidance for earnings growth of 5% to 10%, and continues to expect strong growth thereafter.

At 0903 GMT, shares were down 47.0 pence, or 7.9%, at 550.5 pence.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

December 01, 2021 04:34 ET (09:34 GMT)

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