IMM Immupharma Plc

By Ian Walker

Shares of ImmuPharma PLC fell 23% on Wednesday after the company said Avion Pharmaceuticals--its U.S. partner for its Lupuzor lupus treatment--has received a response from the U.S. Food and Drug Administration giving dosing guidance and advice on an amended study protocol to improve the regulatory outcome.

Shares at 0932 GMT were down 1.54 pence at 5.08 pence, marking the worst one-day percentage fall since November 2019.

The London-listed biopharmaceutical company didn't provide further information on the contents of the FDA's letter, which it described as detailed.

ImmuPharma said it is currently reviewing the response with Avion.

The company said on June 27 that Avion was seeking final regulatory guidance from the FDA as it prepared for the start of the international Phase 3 trial of Lupuzor. It said Lupuzor has met all of the FDA's requirements so far, including all key endpoints in prior trials.

Avion received a Type C meeting confirmation from the FDA on July 7, which concerns the development and review of certain products.

Write to Ian Walker at ian.walker@wsj.com

(END) Dow Jones Newswires

September 14, 2022 05:51 ET (09:51 GMT)

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