Immupharma PLC - Update : FDA confirms 4 Dec for Type ‘A’ meeting
("ImmuPharma" or the "Company")
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update on the announcement issued on
The US Food & Drug Administration ("FDA") has now confirmed the date of
As part of the Type 'A' Meeting, Avion has asked the FDA for guidance on the following:
· Key aspects of the study design, clinical end points and approval process for Lupuzor™; and
· Consideration by the FDA for a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway.
ImmuPharma will provide an update as soon as Avion has met with the FDA and notified ImmuPharma of the outcome.
Commenting on the announcement,
"ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' Meeting for early
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases, metabolic diseases, anti-infectives and cancer. 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 Avion Pharmaceuticals signed on
For additional information about ImmuPharma please visit www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to develop, acquire and market a portfolio of innovative pharmaceutical products in the Women's Health and other therapeutic categories aligned with its mission to improve the quality of patient lives. Avion Pharmaceuticals focuses on identifying opportunities to develop, acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfil unmet medical needs. For more information, visit www.avionrx.com.
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