Shares of Futura Medical plc. (LON: FUM) gapped 35.1% higher after the European Union granted the CE Mark to its over the counter erectile dysfunction gel MED3000 for sale within the region.
The company’s MED3000 gel is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction (ED). The treatment does not need a doctor’s prescription and can be bought over the counter, giving it a significant edge over competing medications.
Being granted the EU CE Marks opens the door for the drug’s approval in other countries that rely on the CE Mark to issue their approval. Such countries are found in the Middle East, Africa, the Far East, and Latin America, where the drug’s approval can be fast-tracked based on the CE Mark.
We recently covered Futura Medical noting that its shares were trading 40% below their March highs and predicted that the EU’s approval would trigger a rally, which we got today.
Futura’s MED3000 drug is on track for approval within the United States, where the company got the go-ahead to run clinical trials of the drug.
James Barder, Futura Medical’s CEO, said: “Today marks a transformational milestone for the company. We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven OTC [over the counter] treatment for erectile dysfunction,”
Adding:
“MED3000 is a highly differentiated product, with a rapid speed of onset addressing significant unmet needs, across all patient severities in the US$5.6bn global ED market. We look forward to further MED3000 marketing approvals in the coming years in multiple regions across the world, including the USA and Asia.”
I am long-term bullish on Futura Medical given MED3000’s significant revenue potential within the EU and globally as the company secures more approvals in different regions over time.
Futura Medical share price.
Futura Medical shares surged 35.14% to trade at 62.30p, having risen from Thursday’s closing price of 46.10p.
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