[ADVERT]
Share Name Share Symbol Market Type Share ISIN Share Description
Evgen Pharma Plc LSE:EVG London Ordinary Share GB00BSVYN304 ORD 0.25P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.0% 5.85 5.80 5.90 5.85 5.74 5.85 1,400 08:00:15
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 0.2 -3.2 -1.8 - 16

Evgen Pharma PLC Glioma Orphan Drug designation granted by FDA

02/09/2021 11:01am

UK Regulatory (RNS & others)


Evgen Pharma (LSE:EVG)
Historical Stock Chart


From Aug 2021 to Oct 2021

Click Here for more Evgen Pharma Charts.

TIDMEVG

RNS Number : 5469K

Evgen Pharma PLC

02 September 2021

Evgen Pharma plc

("Evgen" or the "Company")

Glioma Orphan Drug designation for SFX-01 granted by FDA

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases, announces the grant of an Orphan Drug Designation ("OD") by the US Food and Drug Administration ("FDA") for use of SFX-01 to treat malignant glioma.

The Company, announced submission of an Orphan Drug application to the FDA on 13 July 2021. OD is usually granted when there are fewer than 200,000 patients with a given disease in the United States and there is a scientific rationale for potential use of the product in that condition. As well as recognising the relative rareness of a disease, OD confers intellectual property cover to an investigational drug in the form of data protection at the time of approval of a new drug application, which is additional to any patent cover in force. Tax credits are also possible on eventual US sales of an approved orphan drug.

Dr Huw Jones, CEO of Evgen, commented: "We are delighted that our team and advisors have successfully gained Orphan Drug designation for SFX-01 in the USA in a very short period of time. This is part of a wider strategy to access the US market and positions us well for further investigations of our lead asset in this devastating brain cancer as we continue to optimize SFX-01 for clinical trials and eventually partnering."

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

Enquiries:

 
  Evgen Pharma plc www.evgen.com                                          via Walbrook 
  Dr Huw Jones, CEO 
  Richard Moulson, CFO 
 
  finnCap www.finncap.com                                          +44 (0)20 7220 0500 
  Geoff Nash / Teddy Whiley (Corporate 
   Finance) 
  Alice Lane (ECM) 
 
  Walbrook PR                             +44 (0)20 7933 87870 or evgen@walbrookpr.com 
                                                     +44 (0)7876 741 001 / +44 (0)7980 
  Anna Dunphy / Paul McManus                                                   541 893 
 
 

About Evgen Pharma plc

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex(R), a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.

Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.

The has its headquarters at Alderley Park, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.

For further information, please visit: www.evgen.com

For research on the Company, please visit: http://evgen.com/investors/analyst-coverage/

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

MSCUUVKRAWUKRRR

(END) Dow Jones Newswires

September 02, 2021 06:01 ET (10:01 GMT)

1 Year Evgen Pharma Chart

1 Year Evgen Pharma Chart

1 Month Evgen Pharma Chart

1 Month Evgen Pharma Chart
ADVFN Advertorial
Your Recent History
LSE
EVG
Evgen Phar..
Register now to watch these stocks streaming on the ADVFN Monitor.

Monitor lets you view up to 110 of your favourite stocks at once and is completely free to use.

By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions

P: V:gb D:20211025 08:15:03