Futura Medical PLC (LON:FUM) said it is seeing limited impact from the coronavirus lockdown and that regulatory submissions for its erectile dysfunction treatment remain on track.
The company has developed MED3000, a fast-acting gel that will be targeted at men for whom the current treatments don’t work.
WATCH: Futura Medical's James Barder says regulatory submissions for MED3000 remain on track
It is making a De Novo medical device application in the States for its breakthrough after a successful phase III clinical trial and is seeking sign-off in Europe too.
In an update contained in Futura’s AGM statement, investors were told that a second pre-submission meeting with the US Food & Drug Administration has been now set.
This could allow Futura to file for pre-marketing clearance by the end of the third quarter, it added.
In Europe, Futura said it had experienced no delays with its EU notified body as a result of the new medical device regulations or Covid with its technical dossier “nearing completion”.
Chairman John Clarke said: “As a breakthrough treatment for erectile dysfunction, we remain confident that we will receive MED3000 approval as a medical device and look forward to updating the market on Futura's developments during the remainder of 2020.”
In the same announcement, the research firm said it received a £2.2mln research and development tax credit from the UK tax authorities as it reiterated previous guidance that it has funds sufficient to see through to the second quarter of 2022.
Analysts at broker Liberum reiterated their 'buy' recommendation, saying: “Despite a strong recent performance there is still significant upside at Futura in our view given the string of upcoming catalysts and valuation with a market cap of just £44m versus a potential peak sales of >£300m.”
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