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Lumos Diagnostics (ASX:LDX) has gone from 1.1c to 10.5c in little over a week.
Six months after the FDA knocked it back, the US regulator gave it the green light to enter the US market. So will the run continue?
LDX has taken shareholders on a rollercoaster ride
LDX owns FebriDx, a finger-prick blood test that can indicate if a person has a general bacterial or viral acute respiratory infection within 10 minutes.
After listing in June 2021 at $1.25 per share, it was a long journey down to 1.1c. The decline was at first because it was taking a while for the FDA to get back to Lumos Diagnostics, given the sheer amount of applications in light of the state of the pandemic in the USA.
Arguably the gloss had also come off the technology to the rise of Rapid Antigen Tests.
But then the FDA knocked it back in the middle of last year. The FDA was concerned about the risk of false negatives, thereby missing opportunities to treat patients or worse, cause further infections by enabling further spreading.
LDX tried again in 2023, submitting a new application in February and getting an answer at the end of last month. And this time it was a yes.
So perhaps the rollercoaster is going in the other direction now…
So what now?
Shareholders who haven’t bought in might be tempted too. But there’s no telling how much longer this rally will last, let alone how LDX will perform in the US market. Companies like 4DX (ASX:4DX) and Avita (ASX:AVH) prove that FDA approval and US market entry is no certainty of success.
We feel happy that LDX shareholders have hope now, something they were devoid of for nearly 12 months. But the journey is by no means complete, let alone certain to end well.
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