Futura Medical says 'multiple' potential out-licensing parties' interested in erectile dysfunction gel
The company delivered a comprehensive update on its progress
Company
Futura Medical PLC
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 Medical adds consumer healthcare products veteran to board
Jeff Needham was at Perrigo, the US-based manufacturer and marketer of consumer healthcare products, for 36 years
Futura Medical well-funded and on-track
The results for the six months revealed the company was sitting on £12.76mln as at June 30
Futura Medical agrees third commercial deal for fast-acting erectile gel
It has teamed up with a Swiss company called Labatec Pharma, which will oversee the regulatory sign-off of the product in the Gulf Co-operation Council region as well as Jordan, Lebanon and Iraq
Futura Medical says countdown to regulatory sign-off of erectile dysfunction gel begins
It has hosted the first patient visit as part of the company's FM71 confirmatory study
Futura Medical: More deals will follow after LatAm agreement, says City broker
“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
Futura Medical inks deal that will take its erectile dysfunction gel to Brazil and Mexico
It has partnered with the speciality pharma group, m8 Pharmaceuticals
Futura Medical makes headway with US drug regulator as it looks to sell erectile dysfunction gel over the counter
It has been given sign-off for a simple human factors study by the Food & Drug Administration
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Futura Medical in talks with potential licensing partners; FDA interactions on track
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
Futura Medical raises funds for a small confirmatory clinical study for MED3000
MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction through a unique evaporative mode of action
Futura Medical better placed for commercial deals with EU approval, says Liberum
"Approval removes the last hurdle to signing meaningful commercial agreements"
Futura Medical confirms EU CE mark for MED3000 has been granted
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
How Futura Medical turned MED3000 into a near-billion pound opportunity
The erectile dysfunction gel will be commercialised in Europe this year after the pharma company navigated unexpected twists and turns along the way
Futura Medical well-positioned to announce more positive news on MED3000 after year of milestones
The pharma company is eyeing a global rollout after receiving the CE mark in Europe
Futura Medical soars (again) after US Food & Drug Administration agreement
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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Futura Medical soars as EU clears way for marketing of company's erectile dysfunction gel
"The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000"
Futura Medical targets profitability as erectile dysfunction gel gains commercial traction
Futura Medical has created a technology called DermaSys that delivers active pharmaceuticals through the skin barrier rapidly and effectively
Futura Medical shares rise 21% after it makes significant commercial and financial headway
It has brought in new funds and found a co-development partner
Futura Medical highlights regulatory and commercial progress of erectile dysfunction treatment candidate
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
Futura Medical up almost a fifth after it says it is making commercial and regulatory headway
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
Futura Medical provides update on commercial progress with breakthrough gel
The company has developed a fast-acting erectile dysfunction product that could be sold over the counter
Futura Medical moves nearer EU sign-off for erectile dysfunction gel
Ther group has done so by securing a positive audit opinion for the quality management systems (QMS) around its sexual health product MED3000
Futura Medical has early success with new CBD gel
It has just completed initial laboratory and optimisation work on the new product
Futura Medical submits MED3000 for European approval, US wants new confirmatory trial
Approval is being sought for MED3000 to be sold over-the-counter without a prescription
Futura Medical says regulatory submissions are on track
The update was provided in a statement accompanying the firm's annual meeting
Futura Medical reinitiated at ‘buy’ as Liberum forecasts MED3000 sales potential of £300mln
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 Medical files for pre-submission meeting with the FDA for MED3000
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
Futura Medical gets boost as FDA confirms it will consider flagship product as medical device
The company expects the second meeting with the US food and drug regulator to take place in the coming months
Futura Medical confirms regulatory timeline for breakthrough gel; excited about its commercial potential
“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
Futura Medical to host investor seminar to discuss phase III trial results
The March 26 gathering will hear from Ken James, the company’s head of research and development
Futura Medical says it has held positive initial discussions with EU regulators
In the update, it also said a meeting is lined up with American regulators this quarter
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Futura Medical shoots higher as it raises £3.25mln
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
Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results
The delivery mechanism for the company's erectile dysfunction drug appeared to have a clinically significant impact on men with the condition
Futura Medical worth double current value suggests research house
A major inflexion point will be the results of a pivotal Phase III study (FM57) for MED2005 in December.
Futura Medical’s December trial data could be “game-changing”, says Liberum
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
Futura Medical says latest data add to the growing body of evidence supporting its erectile dysfunction drug
MED2005, which is currently undergoing a phase III clinical trial, demonstrated a “dose-proportional” increases in penile blood flow
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Futura completes landmark ED phase III dosing, expects data by year end
In the same announcement, it said recruitment for a one-year, open-label extension study involving 1,000 men had been successfully concluded
Futura Medical to share data at US sexual medicine conference
The company will also host its third Scientific Advisory Meeting with high profile US key opinion leaders in the field of erectile dysfunction
Futura Medical on track with lead drug
The update in erectile dysfunction treatment MED2005 was provided alongside interim results
Futura Medical agrees joint venture to develop CBD product
“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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Futura Medical mulling fast-track European submission for lead drug candidate
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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Futura Medical completes recruitment for phase III erectile dysfunction treatment
A total of 1,000 men with mild, moderate and severe ED will be treated with MED2005
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Futura’s Phase 3 data for MED2005 could drive 500% share price upside, says Liberum
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
Futura Medical on the rise as Liberum says newspaper article could spark interest in group’s main ED product
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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Futura Medical looking ahead to completion of key phase III ED trial
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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Futura Medical trial on track to deliver “major value inflection point”
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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Futura Medical set to share further safety data
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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Futura Medical plans R&D day
The event will feature a presentation from a key opinion leader in erectile dysfunction
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Futura Medical study results signals the potential of its lead treatment
The company is developing MED2005, a fast-acting gel for men who suffer erectile dysfunction
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MED2002 is being developed as a rapid onset version of pills such as Viagra and Cialis
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Futura Medical raises funds to finance its erectile dysfunction gel through Phase 3 studies
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"
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"Excellent" first half for Futura Medical as first dosing in final stage trial of its ED gel draws near
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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Futura Medical begins Phase III trial for erectile dysfunction treatment as erectogenic condom receives shelf-life approval
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