REG - Immupharma PLC - FDA response for Type C Meeting - update

ImmuPharmaAnnouncement

31/08/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220831:nRSe6692Xa&default-theme=true

RNS Number : 6692X  Immupharma PLC  31 August 2022

 

 
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.

 

 For further information please contact:

ImmuPharma PLC (www.immupharma.com (http://www.immupharma.com) )  + 44 (0) 207 152 4080

 Tim McCarthy, Chairman
 Lisa Baderoon, Head of Investor Relations                         + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                           +44 (0) 203 368 3550 (about%3Ablank)

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                          +44 (0) 203 815 8880

 Patrick Claridge

 John Howes

 Bob Pountney                                                      +44 (0) 1483 413500

 SI Capital (Joint Broker)

 Nick Emerson

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.

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDFFFEITEIIVIF