ImmuPharma Shares Rise on Formal Meeting Confirmation With FDA Over Lupuzor

 ImmuPharma PLC shares rose Thursday after it said that Avion Pharmaceuticals--its U.S. partner for its Lupuzor lupus treatment--has received a Type C Meeting confirmation from the U.S. Food and Drug Administration.

A Type C meeting concerns the development and review of certain products.

The London-listed biopharmaceutical company said that the statement of purpose, objectives and proposed agenda of the meeting have already been agreed on, as has the option to provide written responses, rather than face-to-face meetings. The FDA has agreed to provide a written response by Aug. 29.

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

"We applaud the quick turnaround from the FDA in respect to Avion's request for this Type C Meeting and pleased to note the FDA's confirmation that only a written response is required and no face to face meeting is needed," Chief Executive Tim McCarthy said.

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