Vera Therapeutics Files for Atacicept Approval in Key Kidney Disease
Company seeks accelerated FDA approval for its IgA nephropathy drug, but shares dip in a potential 'sell the news' reaction amid a competitive landscape.
Vera Therapeutics has taken a critical step toward commercializing its lead drug candidate, atacicept, submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the treatment of IgA nephropathy (IgAN), a rare and serious autoimmune kidney disease. Despite the milestone, shares of the biotechnology firm fell nearly 4.1% in trading on Friday, closing at $24.19.
The submission, announced Friday, seeks approval under the FDA's Accelerated Approval Program, a pathway designed to fast-track drugs for serious conditions with unmet medical needs. The application is supported by positive data from the Phase 3 ORIGIN trial, which showed atacicept led to a statistically significant 46% reduction in proteinuria—a key marker of kidney damage—at 36 weeks.
"The submission of our BLA for atacicept is a significant achievement for Vera and a critical step forward for the IgAN community," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, in a press release. "We believe atacicept, with its differentiated mechanism of action, has the potential to be a transformative, disease-modifying therapy."
Atacicept is a potential first-in-class treatment that targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), two cytokines involved in the production of pathogenic autoantibodies that cause IgAN. This dual-action mechanism is what differentiates it in an increasingly competitive field.
The stock's negative reaction may reflect a classic "buy the rumor, sell the news" scenario, as investors had widely anticipated the filing. It also comes as the treatment landscape for IgAN, also known as Berger's disease, is rapidly evolving. Several therapies have gained FDA approval in recent years, including Calliditas Therapeutics' Tarpeyo, Travere Therapeutics' Filspari, and Novartis' Fabhalta.
Novartis has also recently entered the market with the approval of Atrasentan, and Otsuka's sibeprenlimab had its BLA accepted by the FDA earlier in the year, signaling a crowded market where Vera will need to carve out a distinct position.
Despite the competitive pressures, Wall Street analysts remain largely optimistic about Vera's prospects. The consensus 12-month price target for VERA stock sits near $62, suggesting a significant potential upside from its current levels. Analysts' optimism is rooted in atacicept's strong clinical data and its novel mechanism, which could offer a new line of defense for patients who do not respond to existing treatments. On Friday, analysts at J.P. Morgan maintained an 'Overweight' rating on the company, even as they slightly adjusted their price target to $52 from $53.
The FDA's acceptance of the BLA for review, which typically occurs within 60 days of submission, will be the next major catalyst for the company. An acceptance would formalize the review timeline and set a potential Prescription Drug User Fee Act (PDUFA) date for an approval decision. Given atacicept's previously granted Breakthrough Therapy Designation, the review process may be expedited.
For Vera Therapeutics, a clinical-stage company with no revenue to date, a potential FDA approval would be transformative, validating its scientific platform and setting the stage for its first commercial launch. The company's future now rests on navigating the final stages of the regulatory process and preparing for a competitive market entry.