Faron Pharmaceuticals Oy (DI) (FARN)

Sector:

Pharma and Biotech

Index:

FTSE AIM All-Share

165.00p
   
  • Change Today:
    -7.50p
  • 52 Week High: 350.00
  • 52 Week Low: 92.50
  • Currency: UK Pounds
  • Shares Issued: 104.62m
  • Volume: 13,161
  • Market Cap: £172.63m

Faron's 'Traumakine' set for swift progress through FDA process

By Josh White

Date: Monday 04 Sep 2017

LONDON (ShareCast) - (ShareCast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals announced on Monday that the FDA had proposed that the company could proceed directly to Biologics License Application (BLA) submission, pending positive results from the two ongoing Phase III trials with the company's wholly-owned product, 'Traumakine', for the treatment of acute respiratory distress syndrome (ARDS).
The AIM-traded firm said that in the letter received on 1 September, the FDA proposed that - subject to the regulator being satisfied with data from the trials - the BLA application for Traumakine could be filed purely with data obtained from the ongoing trials outside of the US.

In the event of positive outcomes of the ongoing trials, Faron said that FDA feedback was therefore expected to shorten the time for approval of Traumakine in the US.

"We welcome the news that the FDA have proposed that we proceed directly to BLA submission for the US development of Traumakine," said CEO Dr Markku Jalkanen.

"This important feedback potentially speeds up the regulatory approval process in the US and brings us one step closer to delivering Traumakine to patients in the world's largest pharmaceutical market."

Dr Jalkanen said there was currently no approved pharmaceutical treatment for ARDS, and claimed Traumakine had the potential to address a "significant unmet medical need" in terms of mortality and savings for society.

"We now eagerly await the outcome of our ongoing Phase III trials and continue to build our presence in the US."

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FARN Market Data

Currency UK Pounds
Share Price 165.00p
Change Today -7.50p
% Change -4.35 %
52 Week High 350.00
52 Week Low 92.50
Volume 13,161
Shares Issued 104.62m
Market Cap £172.63m

FARN Star Ratings

Compare performance with the sector and the market.
more star ratings
Key: vs Market vs Sector
Value
Market averageMarket averageMarket averageMarket averageMarket average
60% below the sector average60% below the sector average60% below the sector average60% below the sector average60% below the sector average
Price Trend
Market averageMarket averageMarket averageMarket averageMarket average
34.69% above the sector average34.69% above the sector average34.69% above the sector average34.69% above the sector average34.69% above the sector average
Income Not Available
Growth Not Available

What The Brokers Say

Strong Buy 1
Buy 1
Neutral 0
Sell 0
Strong Sell 1
Total 3
neutral
Broker recommendations should not be taken as investment advice, and are provided by the authorised brokers listed on this page.

FARN Dividends

No dividends found

Trades for 31-Oct-2024

Time Volume / Share Price
16:42 10,000 @ 165.00p
14:36 60 @ 167.00p
12:27 751 @ 173.00p
11:00 1,295 @ 173.00p
08:36 473 @ 166.00p

FARN Key Personnel

CFO Yrjö E K Wichmann
CEO Juho Jalkanen
Chair Tuomo Pätsi

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