ImmuPharma Shares Rise on Formal Meeting Confirmation With FDA Over Lupuzor
July 07 2022 - 5:47AM
Dow Jones News
By Joe Hoppe
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.
Shares at 0908 GMT were up 10.0 pence, or 2.3% at 445.0
pence.
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.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
July 07, 2022 05:32 ET (09:32 GMT)
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