The company is now tantalizingly close to commercializing its leading drug candidate.
The mood on the stock market was gloomy on Monday, but apparently somebody forgot to notify Belite Bio (BLTE +12.06%). The company, a clinical-stage biotech focused on developing therapies for eye disorders, saw its share price zoom 12% higher thanks to an encouraging update from the laboratory.
Seeing more clearly
That morning, Belite announced that its leading drug candidate, tinlarebant, met its primary endpoint in a phase 3 trial. The medicine was being tested to determine its efficacy in treating adolescents with Stargardt disease, a condition that can lead to loss of central vision.
Image source: Getty Images.
Tinlarebant was found to produce a nearly 36% reduction in lesion growth, a key feature of the affliction, compared to a placebo. Belite added that it recorded minimal change in visual acuity after 24 months.
In its press release touting the readout, Belite quoted CEO Tom Lin as saying that “Not only was tinlarebant shown to be efficacious in slowing retinal degeneration, but this is also the first time that an oral treatment was able to demonstrate a clinically meaningful outcome in retinal degenerative disease.”
The healthcare company said that it aims to submit New Drug Applications for the medication in the first half of next year.
Today’s Change
(12.06%) $16.58
Current Price
$154.02
Key Data Points
Market Cap
$5B
Day’s Range
$130.06 – $154.99
52wk Range
$49.00 – $154.99
Volume
753K
Avg Vol
89K
Gross Margin
0.00%
Dividend Yield
N/A
A vision for the future
As always, I must caution that, regardless of how well a drug performs in a late-stage trial, regulatory approval is by no means guaranteed.
However, tinlarebant is clearly efficacious in treating a disease that is pernicious and highly problematic. Given that, I’d say at least a U.S. Food and Drug Administration (FDA) nod is likely. Monday’s investor reaction, in my opinion, was fully justified.
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
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