Company
LON:FUM
Futura Medical specialises in the development and global commercialisation of innovative sexual health products, including lead product Eroxon®. The company's core strength lies in its research, development and commercialisation of topically delivered gel formulations in sexual health products.
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“Futura is talking to many more potential partners as it works to build the global commercialisation landscape, and we expect more licensing agreements to be signed in the coming months,” said Liberum in a note to clients
It has partnered with the speciality pharma group, m8 Pharmaceuticals
It has been given sign-off for a simple human factors study by the Food & Drug Administration
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A glance at some of the day's highlights from the Proactive Investors newswire
Chairman John Clarke will tell the firm's AGM: “The team is laser-focused on preparation and execution of the confirmatory clinical study and the non-clinical study to finalise an OTC [over-the-counter] label for the regulatory submission f
MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction through a unique evaporative mode of action
"Approval removes the last hurdle to signing meaningful commercial agreements"
Futura's fast-acting topical gel formulation MED3000 is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction available over the counter
The erectile dysfunction gel will be commercialised in Europe this year after the pharma company navigated unexpected twists and turns along the way
The pharma company is eyeing a global rollout after receiving the CE mark in Europe
The main purpose of the trial is to ensure that the efficacy of the erectile dysfunction gel does not wear off after more than three months of use.
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A glance at some of the day's highlights from the Proactive Investors newswire
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A look at Friday's major share movers in the London Stock Exchange
"The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000"
Futura Medical has created a technology called DermaSys that delivers active pharmaceuticals through the skin barrier rapidly and effectively
It has brought in new funds and found a co-development partner
The pharma company has submitted a final detailed clinical study protocol to the FDA and a meeting has been scheduled for February to agree on details of a statistical analysis plan for the MED3000 treatment
In an update, investors were told discussions were taking place with a “growing number” of potential partners interested in helping Futura exploit the commercial potential of MED3000 as an over-the-counter treatment
The company has developed a fast-acting erectile dysfunction product that could be sold over the counter
Ther group has done so by securing a positive audit opinion for the quality management systems (QMS) around its sexual health product MED3000
It has just completed initial laboratory and optimisation work on the new product
Approval is being sought for MED3000 to be sold over-the-counter without a prescription
The update was provided in a statement accompanying the firm's annual meeting
The broker said with the right commercialisation partner, the firm's erectile dysfunction treatment could take a 15% market share in the US and EU
Futura has filed for a further pre-submission meeting with the FDA to follow up the initial presentation of existing clinical evidence from the FM57 study to the FDA in February
The company expects the second meeting with the US food and drug regulator to take place in the coming months
“Following positive feedback after consultations with regulators we are confident MED3000 has a well-defined path to approval as a medical device as a clinically proven ED [erecrtile dsyfunction] therapy,” said chief executive James Barder
The March 26 gathering will hear from Ken James, the company’s head of research and development
In the update, it also said a meeting is lined up with American regulators this quarter
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A glance at some of the day's highlights from the Proactive Investors newswire
The issue of new shares is being 'cornerstoned' by Swiss Private Bank Lombard Odier, while a retail tranche will be done via the financial platform Primary Bid
The delivery mechanism for the company's erectile dysfunction drug appeared to have a clinically significant impact on men with the condition
A major inflexion point will be the results of a pivotal Phase III study (FM57) for MED2005 in December.
The broker said the phase III clinical trial, which is expected to report by the middle of next month, had been “significantly de-risked” and had an over 70% chance of delivering a positive outcome
MED2005, which is currently undergoing a phase III clinical trial, demonstrated a “dose-proportional” increases in penile blood flow
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In the same announcement, it said recruitment for a one-year, open-label extension study involving 1,000 men had been successfully concluded
The company will also host its third Scientific Advisory Meeting with high profile US key opinion leaders in the field of erectile dysfunction
The update in erectile dysfunction treatment MED2005 was provided alongside interim results
“The benefits and applications of cannabis and cannabidiol in both the medical and consumer markets are well known and expanding rapidly," said Futura boss James Barder.
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A glance at some of the day's highlights from the Proactive Investors newswire
Depending on the read-out from current study, it may opt to submit the results from just one phase III trial in Europe. But at this stage it is only considering this option
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On Wall Street, stocks were heading higher, through albeit with not much gusto
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Aside from the two mid-cap transport operators, blue chip contractor Bunzl will also issue a trading update, while the macro focus will be on the G20 meeting in Japan
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A glance at some of the day's highlights from the Proactive Investors newswire
A total of 1,000 men with mild, moderate and severe ED will be treated with MED2005
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All eyes will be on the statement from Fed rate setters later, especially due to the pressure to lower rates from President Trump
In an initiation note, Liberum’s analysts forecast peak sales potential for MED2002 at £500mln, ten times the company’s current market cap of £50mln
Over the weekend The Guardian published an in-depth piece on the emerging treatments for erectile dysfunction (ED) with a significant focus on Futura's MED2005 product
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A glance at some of the day's highlights from the Proactive Investors newswire
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Headline results from the trial of MED2005 are due before the end of 2019, while Futura is also confident of hearing back from UK regulators about its pain relief gel later in the year
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A look at some of the top risers and fallers in London on Wednesday
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A glance at some of the day's highlights from the Proactive Investors newswire
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The first of two phase III studies of MED2005 got underway in October, treating 1,000 men at 60 centres across Europe
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The raft of macro-economic news from the US, the UK and ECB policy failed to cheer the FTSE 100 as the focus turned to the meeting in Brussels
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With the latest data showing the supermarket losing market share to discounters, investors will be hoping for news on how the group plans to maintain its position at the top
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Also on the retail front, WH Smith and Dunelm will issue updates as well in the Week Ahead, while on the macro front an ECB rate decision and US FOMC meeting minutes are also due
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A look at the day's major movers, including Sabien technology, Stock Spirits, Simigon,UK Oil & Gas, Tungsten, WANdisco, Restaurant Group and Titon
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A glance at some of the day's highlights from the Proactive Investors newswire
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FTSE 100 closed up just over six points at 7,197, while FTSE 250 shed over 74 at 18,898
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A glance at some of the day's highlights from the Proactive Investors newswire
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A look at the day's major movers, including Sensyne Health, Reabold Resources, Maintel, Nu-Oil, Altona Energy, Flybe and PCI-PAL
The latest round of tests carried is what’s called impedance testing, which compared MED2005 to two commercially available lubricants used for sexual intercourse
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A deceptively dull start by the Footsie gradually turned into something a bit more dramatic
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A glance at some of the day's highlights from the Proactive Investors newswire
The event will feature a presentation from a key opinion leader in erectile dysfunction
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At the close, the FTSE 100 was down 71.93 points, or 1.1% at 6,773.24, just above the session low of 6,761.37 and well below the early high of 6,845.17.
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A glance at some of the day's highlights from the Proactive Investors newswire
The company is developing MED2005, a fast-acting gel for men who suffer erectile dysfunction
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A glance at some of the day's highlights from the Proactive Investors newswire
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MED2002 is being developed as a rapid onset version of pills such as Viagra and Cialis
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The FTSE 100 closed up around 92 points at 7,182. FTSE 250 also gained..
A look at some winners and losers in UK equity trading during Friday's session
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A glance at some of the day's highlights from the Proactive Investors newswire
Three directors have subscribed for shares. Two independent directors have consulted with Futura's nomad and deemed that the terms of the participating directors' participation in the subscription are "fair and reasonable"
The UK blue-chip index closed up almost 23 points at 7,049 - up around 0.77% on the week as a whole
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A glance at some of the day's highlights from the Proactive Investors newswire
The pharma group expects to dose the first patient in the Phase III trial of its MED2002 erectile dysfunction treatment within the next month
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The UK blue-chip index closed nearly four points higher at 7,511
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Aside from the US interest rate decision, corporate updates are due from online fashion retailer Boohoo Group, outsourcer MITIE, and automotive services firm The AA ...
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Aside from the latest Federal Reserve policy meeting, the week ahead will bring updates from the likes of Next, Thomas Cook, TUI, United Utilities, and Pennon
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A glance at some of the day's highlights from the Proactive Investors newswire
A look at some of the biggest risers and fallers in the UK market on Wednesday
The pharmaceuticals firm said that the MED2002 trial would involve 1,000 patients with headline data expected by the end of 2019
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The FTSE 100 closed nearly 31 points higher at 7,331, while FTSE 250 added over 42 at 20,500
A look at some of the biggest risers and fallers in London on Monday
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A glance at some of the day's highlights from the Proactive Investors newswire
Futura’s commercialisation partner for TPR100, Thornton & Ross, has filed the product’s marketing authorisation application with UK regulators
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In London, FTSE 100 shed 23 points to 7,655, while FTSE 250 shed over 155 points at 20,770
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A glance at some of the day's highlights from the Proactive Investors newswire
A look at some of the biggest risers and fallers in London on Thursday
The AIM-listed firm said the trial will be a dose ranging, multicentre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically applied glyceryl trinitrate (GNT)
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Imports in the period fell 2.1%, while exports increased 2.4%
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A glance at some of the day's highlights from the Proactive Investors newswire
