Watch LIVE the focusIR May Investor webinar with guest speakers from WS Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksImmupharma Regulatory News (IMM)

Share Price Information for Immupharma (IMM)

London Stock Exchange
Share Price is delayed by 15 minutes
Get Live Data
Share Price: 2.36
Bid: 2.35
Ask: 2.41
Change: 0.23 (10.70%)
Spread: 0.06 (2.553%)
Open: 2.20
High: 2.45
Low: 2.20
Prev. Close: 2.15
IMM Live PriceLast checked at -

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

Lupuzor Update

30 Sep 2022 07:30

RNS Number : 2629B
Immupharma PLC
30 September 2022
 

30 September 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Lupuzor™ Update

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, provides an update on Lupuzor™, following the Company's recent announcement on 14 September 2022, that its US partner for Lupuzor™ (P140), Avion Pharmaceuticals ("Avion"), had received a written response from the Food and Drug Administration ("FDA") to the Type C meeting.

 

In summary, the FDA response earlier this month, recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor™ in Lupus, to optimise the clinical benefit to Lupus patients and to maximise efficacy. In addition, the FDA made additional recommendations on clinical measurements, again to support Lupuzor™ through the regulatory process to approval.

 

Since then, both ImmuPharma and Avion, with their clinical and regulatory teams and advisors, have been reviewing in detail the FDA's written response and recommendations.

 

Further details on the next steps for Lupuzor™ will be communicated to the market, once finalised between ImmuPharma and Avion.

 

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma said:

 

"Following receipt of the FDA letter earlier this month, we welcome the helpful recommendations from the FDA on the next steps in the Lupuzor™ clinical program. We equally recognise shareholders' frustrations on what is a very complex regulatory process, which is having an impact on moving Lupuzor™ forward. However, we are working very closely with the clinical and regulatory teams at Avion to accommodate the FDA's recommendations and decide on the next steps. We will update the market as soon as we have further guidance to share."

 

 

This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

 

Ends

 

 

For further information please contact:

 

ImmuPharma PLC (www.immupharma.com)

Tim McCarthy, Chief Executive Officer

Lisa Baderoon, Head of Investor Relations

+44 (0) 207 206 2650

 

+ 44 (0) 7721 413496

 

 

SPARK Advisory Partners Limited (NOMAD)

Neil Baldwin

 

Stanford Capital Partners (Joint Broker)

Patrick Claridge, John Howes, Bob Pountney

 

SI Capital (Joint Broker)

Nick Emerson

 

+44 (0) 203 368 3550

 

 

+44 (0) 20 3650 3650

 

 

+44 (0) 1483 413500

 

 

 

 

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 for the treatment of Lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action.

 

For additional information about ImmuPharma please visit www.immupharma.co.uk

 

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 or visit 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.
 
END
 
 
UPDPPUBUBUPPPWB
Date   Source Headline
30th Jul 20217:00 amRNSBoard Changes
16th Jul 20217:00 amRNSBoard Appointment
28th Jun 202112:27 pmRNS2021 RESULT OF ANNUAL GENERAL MEETING -REPLACEMENT
28th Jun 202111:03 amRNS2021 RESULT OF ANNUAL GENERAL MEETING
24th Jun 20214:41 pmRNSSecond Price Monitoring Extn
24th Jun 20214:36 pmRNSPrice Monitoring Extension
24th Jun 20217:00 amRNSUpdate: Lupzuor™ PK study
2nd Jun 20217:00 amRNSNotice of AGM and posting of Report & Accounts
24th May 20217:00 amRNSDirector Retirement
29th Apr 20214:35 pmRNSPrice Monitoring Extension
29th Apr 20217:00 amRNSFinal Results
16th Apr 20214:41 pmRNSSecond Price Monitoring Extn
16th Apr 20214:36 pmRNSPrice Monitoring Extension
25th Feb 20214:41 pmRNSSecond Price Monitoring Extn
25th Feb 20214:35 pmRNSPrice Monitoring Extension
9th Feb 20217:00 amRNSUpdate- scheduled Phase 3 trials in lupus patients
18th Jan 20217:00 amRNSAppointment of Company Secretary
4th Jan 20217:00 amRNSHolding(s) in Company
2nd Dec 20207:00 amRNSIMM TO PRESENT AT BIOTECH SHOWCASE DIGITAL 2021
30th Nov 20207:00 amRNSTotal Share Capital Notification
26th Nov 20207:00 amRNSGrant of Share Options & PDMR dealing
24th Nov 20207:00 amRNSConversion of Convertible Security
23rd Nov 20207:00 amRNSConversion of Convertible Security
20th Nov 20207:00 amRNSUpdate : FDA confirms 4 Dec for Type ‘A’ meeting
18th Nov 20207:00 amRNSTotal Share Capital Notification - Replacement
10th Nov 20207:00 amRNSUpdate on submission to the FDA
30th Sep 20207:01 amRNSTotal Share Capital Notification
30th Sep 20207:00 amRNSInterim Results
29th Sep 20207:00 amRNSShare Subscription into Incanthera plc
22nd Sep 20207:00 amRNSRepayment of Convertible Security
11th Sep 20207:59 amRNSUpdate on submission to the FDA
10th Sep 202010:59 amRNSConversion of Convertible Security
9th Sep 20201:45 pmRNSConversion of Convertible Security
8th Sep 20203:49 pmRNSHolding(s) in Company
8th Sep 20209:00 amRNSDirector/PDMR Shareholding / TR -1
7th Sep 20207:02 amRNSPlacing - update; related party transaction)
3rd Sep 20207:00 amRNSConversion of Convertible Security
2nd Sep 20207:00 amRNSPlacing to raise £6.5 million
1st Sep 20207:00 amRNSHolding(s) in Company
27th Jul 20207:00 amRNSFDA submission for Special Protocol Assessment
18th Jun 202011:31 amRNS2020 AGM – ALL RESOLUTIONS PASSED
16th Jun 20207:00 amRNSTotal Share Capital Notification
11th Jun 202012:00 pmRNSTR-1 Notification of major holdings
11th Jun 20207:00 amRNSSTRAT. INVTS FROM 2 SPECIALIST US H'CARE INVESTORS
5th Jun 20207:00 amRNSChange of Registered Office Address
2nd Jun 20207:00 amRNSNotification of Change of AGM Venue
21st May 20207:00 amRNSNotice of AGM and posting of Report & Accounts
18th May 20201:45 pmRNSTR-1: Notification of major holdings
14th May 20207:00 amRNSEfforts in fight vs Covid-19 with Lupuzor; Ureka
30th Apr 20209:57 amRNSAudited Report & Accounts published on website

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.