31 August 2022
ImmuPharma plc
("ImmuPharma" or the "Company")
FDA response for Type C Meeting - update
ImmuPharma plc (LSE : IMM), the specialist drug discovery and development company, announced on 7 July 2022 that its US partner for Lupuzor™ (P140), Avion Pharmaceuticals ("Avion"), had advised that it had received Type C Meeting confirmation from the Food and Drug Administration ("FDA").
It was announced at that time that : the statement of purpose, objectives, and proposed agenda of the Type C meeting have been agreed with the FDA, that the FDA also agreed that written responses to the agenda items would be the most appropriate means for responding and that a face to face meeting was not required, and that the agreed date from the FDA for providing its written responses was 29 August 2022.
As of 30 August 2022, Avion has not yet received the written response from the FDA. The Company is in close contact with Avion and have been advised that the FDA is experiencing general delays in meeting response dates and that this is not specific to Avion and the Type C meeting for Lupuzor™ (P140). The Company will notify the market as soon as practicable once a response from the FDA has been received.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
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Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases and anti-infectives. The lead program, Lupuzor™, is a first-in class autophagy immunomodulator which is in Phase 3 for the treatment of lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action. ImmuPharma and Alora Pharmaceuticals signed on 28 November 2019, an exclusive licence and development agreement and trademark agreement for Lupuzor™ to fund a new international Phase 3 trial for Lupuzor™ and commercialise in the US.
For additional information about ImmuPharma please visit www.immupharma.com. ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.
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