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Share Name Share Symbol Market Type Share ISIN Share Description
Immupharma Plc LSE:IMM London Ordinary Share GB0033711010 ORD 10P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.175 1.31% 13.55 13.35 13.75 14.10 13.50 13.80 1,009,827 09:02:44
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 0.1 -6.7 -4.0 - 33

Immupharma PLC Update : FDA confirms 4 Dec for Type 'A' meeting

20/11/2020 7:00am

UK Regulatory (RNS & others)


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RNS Number : 9464F

Immupharma PLC

20 November 2020

20 November 2020

ImmuPharma PLC

("ImmuPharma" or the "Company")

FDA confirms 4 December 2020 for Type 'A' meeting to discuss guidance on forthcoming international Phase 3 trial of Lupuzor(TM) in Lupus patients

ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update on the announcement issued on 10 November 2020, in respect to the new optimised international Phase 3 trial of Lupuzor(TM) in systemic lupus erythematosus ("SLE"), a potentially life-threatening auto-immune disease.

The US Food & Drug Administration ("FDA") has now confirmed the date of 4 December 2020 for a Type 'A' Meeting Request, with Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for Lupuzor(TM).

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(TM); and

-- Consideration by the FDA for a conditional approval of Lupuzor(TM), 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, Dimitri Dimitriou, CEO of ImmuPharma said :

"ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' Meeting for early December 2020. We look forward to providing a further update to the market following confirmation from Avion of the FDA's guidance post this meeting."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")

 
 For further information please contact: 
   ImmuPharma PLC ( www.immupharma.com ) 
    Tim McCarthy, Chairman                        + 44 (0) 207 152 4080 
   Dimitri Dimitriou, Chief Executive Officer 
   Lisa Baderoon, Head of Investor Relations      + 44 (0) 7721 413496 
   SPARK Advisory Partners Limited (NOMAD) 
    Neil Baldwin 
 
    Stanford Capital Partners (Joint Broker)      +44 (0) 203 36 8 3550 
    Patrick Claridge 
    John Howes 
    Bob Pountney                                   +44 (0) 203 815 8880 
 
    SI Capital (Joint Broker) 
    Nick Emerson                                   +44 (0) 1483 413500 
   4Reliance (Euronext Growth Listing Sponsor)    +32 (0) 2 747 02 60 
    Jean-Charles Snoy 
 
    Degroof Petercam (Liquidity Provider)          +32 (0) 2 287 95 34 
    Erik De Clippel 
 
    Backstage Communication 
    Olivier Duquaine                               +32 (0) 477 504 784 
    Gunther De Backer                              +32 (0) 475 903 909 
 

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(TM), 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 28 November 2019, an exclusive licence and development agreement and trademark agreement for Lupuzor(TM) to fund a new international Phase 3 trial for Lupuzor(TM) and commercialise in the US.

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 .

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 or visit www.rns.com.

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November 20, 2020 02:00 ET (07:00 GMT)

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