Futura Medical (FUM) Shares Surged 9.53% on ED Drug Progress

The Futura Medical plc. (LON: FUM) share price surged 9.53% after revealing that it had submitted all the confirmatory data requested by the US Food and Drug Administration (FDA) concerning approving its MED3000 erectile dysfunction (ED) drug in the USA.

The company noted that it had provided detailed information to the FDA in response to the regulator’s questions following its initial submission. After reviewing the recently-submitted data, Futura expects the FDA to grant its De Novo request in Q2 2023.

Investors cheered the announcement, meaning that Futura is one step closer to getting its MED3000 ED drug approved in the United States, the world’s largest single market for ED drugs. The approval of MED3000 would make it the first ever over-the-counter ED medication that does not need a doctor’s prescription. 

The markets eagerly await the FDA to approve MED3000 after successfully completing the phase 3 clinical trial mandated by the FDA before considering approving the ED drug for sale within the United States of America. 

MED3000 has already been approved within the European Union and the United Kingdom. Futura Medical is working on distributing the treatment within the EU countries that accept CE-marked medications and treatments. 

Investors are also concerned about Futura’s manufacturing and distribution capacity, given the anticipated high demand for MED3000 in the USA and Europe due to its over-the-counter availability. 

Meanwhile, investors must wait for further updates from Futura Medical to discover when MED3000 shall be approved in the US and to monitor the company’s progress in distributing the drug across Europe and other countries that accept the CE mark. 

*This is not investment advice. 

Futura Medical (FUM) share price. 

The Futura Medical share price surged 9.53% to trade at 46.55p, from Tuesday’s closing price of 42.50p.