Futura Medical (FUM)

Sector:

Pharma and Biotech

Index:

FTSE AIM All-Share

16.00p
   
  • Change Today:
    -1.00p
  • 52 Week High: 47.50
  • 52 Week Low: 7.75
  • Currency: UK Pounds
  • Shares Issued: 245.63m
  • Volume: 172,759
  • Market Cap: £39.30m
  • RiskGrade: 504

Futura files for second FDA meeting over erection gel

By Josh White

Date: Monday 20 Apr 2020

LONDON (ShareCast) - (Sharecast News) - Futura Medical has filed for a further pre-submission meeting with the US Food and Drug Administration (FDA), it announced on Monday, following receipt of the complete and signed clinical study report for its phase 3 Study, 'FM57'.
The AIM-traded firm said the filing followed the initial presentation of existing clinical evidence from the FM57 study at an FDA pre-submission meeting on 24 February.

It noted that FM57 reported top line results in December, describing it as a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study for its lead product, 'MED3000' - a topical treatment for erectile dysfunction (ED).

The study reportedly demonstrated that MED3000 had the potential to be a highly effective, clinically proven topical treatment for erectile dysfunction, with a fast onset of action and excellent safety profile.

As it disclosed on 6 April, the US FDA had agreed to a 'De Novo' medical device application for MED3000, subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and post-marketing requirements, with reference to the full FM57 clinical study report and other supporting information.

Futura said it had now filed for the pre-submission meeting, and expected that second meeting to take place in the coming months.

If the outcome of the meeting is positive, it could lead to a US submission filing in the third quarter of 2020, for FDA review for pre-marketing clearance.

"Following extensive review of the clinical data, we are pleased to have received the completed and signed clinical study report for FM57, and have filed the necessary data in order for the company to have the next pre-submission meeting to further discuss clinical sufficiency and post-marketing requirements for MED3000," said chief executive officer James Barder.

"As a breakthrough treatment for erectile dysfunction, we are confident that we will receive MED3000 approval as a medical device, and we continue to target the next six months for regulatory submissions in both Europe and the US."

At 1557 BST, shares in Futura Medical were up 11.22% at 11.4p.

Email this article to a friend

or share it with one of these popular networks:


Note 1: Prices and trades are provided by Digital Look Corporate Solutions and are delayed by at least 15 minutes.

Note 2: RiskGrade figures are provided by RiskMetrics.

 

Futura Medical Market Data

Currency UK Pounds
Share Price 16.00p
Change Today -1.00p
% Change -5.88 %
52 Week High 47.50
52 Week Low 7.75
Volume 172,759
Shares Issued 245.63m
Market Cap £39.30m
RiskGrade 504

Futura Medical Star Ratings

Compare performance with the sector and the market.
more star ratings
Key: vs Market vs Sector
Value
49.04% below the market average49.04% below the market average49.04% below the market average49.04% below the market average49.04% below the market average
41.82% below the sector average41.82% below the sector average41.82% below the sector average41.82% below the sector average41.82% below the sector average
Price Trend
16.99% below the market average16.99% below the market average16.99% below the market average16.99% below the market average16.99% below the market average
40.35% below the sector average40.35% below the sector average40.35% below the sector average40.35% below the sector average40.35% below the sector average
Income Not Available
Growth Not Available

What The Brokers Say

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

Futura Medical Dividends

No dividends found

Trades for 09-Jul-2020

Time Volume / Share Price
15:47 1,500 @ 16.09p
15:08 5,000 @ 15.70p
14:51 10,386 @ 16.00p
14:35 10,000 @ 15.72p
14:08 4,850 @ 15.98p

Futura Medical Key Personnel

CEO James Henry Barder
Finance Director Angela Hildreth

Top of Page