Jan. 7 at 12:44 PM
$VERA $50.00 +3.48
Holding long position at a gain.
https://stocktwits.com/G101SPM/message/635070933
UPDATE: The FDA accepted Vera Therapeutics' Biologics License Application for atacicept for adults with IgA nephropathy and granted Priority Review with a PDUFA target date of July 7, 2026.
If approved, atacicept would be the first B-cell modulator targeting both BAFF and APRIL for the treatment of IgAN and would be administered as a once-weekly subcutaneous injection via autoinjector.
The BLA was submitted under the Accelerated Approval Program and is supported by interim ORIGIN 3 trial data showing a statistically significant and clinically meaningful reduction in proteinuria versus placebo.
Atacicept previously received FDA Breakthrough Therapy Designation for IgAN, reflecting the high unmet medical need in the disease.
