One of the happiest moments an investor in the biotech sector can have is when one of his or her companies reports a regulatory submission for a promising product. Sure enough, investors snapped up shares of Vera Therapeutics (VERA 3.21%) on Wednesday, sending them to a nearly 5% gain, on the company's news that it made such a filing.
FDA decision coming soon
That morning, Vera announced that its biologics license application (BLA) for its atacicept was accepted for priority review by U.S. healthcare regulator, the Food and Drug Administration (FDA). Atacicept is a drug that targets IgA nephropathy (IgAN), a kidney affliction that's also known as Berger's disease.
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The company's BLA was assigned a target action date -- i.e., deadline -- of July 7, 2026, by the FDA. If the regulator approves the drug, which is self-administered via injection, Vera could have it on pharmacy shelves shortly thereafter.
The atacicept application was supported by a Phase 3 study that met its primary endpoint of reducing proteinuria, a condition characterized by excessive protein in the urine.
NASDAQ: VERA
Key Data Points
Pricing is key
In its press release updating the progress of the drug, Vera quoted founder and CEO Marshall Fordyce as saying that the "FDA's priority review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape."
If the treatment wins FDA approval, its success will depend on pricing. Vera's rival, Otsuka Pharmaceutical, which earned an FDA nod for a similar medication called Voyxact last November, has apparently set the cost of that drug at $30,000 for each monthly treatment.
