Thursday, Vera Therapeutics Inc VERA announced 72-week data from the open-label extension (OLE) period of its Phase 2b ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN).
Data from the OLE show the consistent and sustained reductions of serum galactose-deficient IgA1 (Gd-lgA1), hematuria, and urine protein to creatinine ratio (UPCR), as well as the stability of eGFR over 72 weeks in participants with IgAN.
Raymond James analysts Ryan Deschner and Steven Seedhouse upgraded Vera Therapeutics, noting that the data set exceeded their expectations.
The analysts write that the data confirms that atacicept is the most low-risk drug candidate for IgA nephropathy (IgAN).
The dataset establishes a strong, long-term glomerular filtration rate (eGFR) durability as a significant benchmark for distinguishing IgAN drugs. This sets a high standard for competitors who may struggle to produce a comparable dataset for a considerable period.
The analysts upgraded the stock from Outperform to Strong Buy and raised the price target from $29 to $37.
Investors have expressed concerns about the frequency of dosing, particularly with competitors exploring different dosing schedules.
Despite previous intentions to explore less-frequent dosing in post-marketing, Vera Pharma has now formally added “IgAN extended dosing” to their pipeline.
During an event, they presented simulation data indicating comparable exposure for weeks 48-52 in a 52-week study between 150mg weekly (Phase 3 dosing) and 600mg monthly administration.
While the risk of losing market share due to convenience in administration is acknowledged, the company’s current strategy focuses on quickly entering the market and establishing a strong presence with a dose-optimized, at-home autoinjector.
Price Action: VERA shares are up 21.65% at $30.79 on the last check Friday.
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