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"
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 targets profitability as erectile dysfunction gel gains commercial traction
Deep Dive - Futura Medical PLC
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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A glance at some of the day's highlights from the Proactive Investors newswire
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