Vera Therapeutics, Inc.
VERA
announced positive top-line data from the phase IIb ORIGIN study evaluating its lead product candidate, atacicept, for treating patients with immunoglobulin A nephropathy (IgAN).
The double-blind, placebo-controlled ORIGIN study evaluated the safety and efficacy of atacicept in 116 patients with IgAN. Data from the same showed that treatment with atacicept led to a statistical significance in the 150 mg dose group with a 33% mean reduction in proteinuria from baseline at 24 weeks — the primary endpoint of the study.
The safety profile of atacicept was similar to that of placebo in IgAN patients.
Vera plans to advance the development of atacicept into a pivotal phase III study in the first half of 2023 after discussions with the FDA.
Despite the positive news, shares of Vera were down 58.5% in the after-hours trading on Tuesday, following the announcement of the news. The stock has plunged 18% in the past year compared with the
industry
’s decline of 17.4%.
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We note that IgAN is a common cause of kidney failure and has a high unmet medical need for its treatment. Several other companies are developing treatments for treating IgAN.
Alnylam Pharmaceuticals
ALNY
is developing cemdisiran, an investigational RNAi therapeutic, targeting the C5 component of the complement pathway, for treating IgAN in collaboration with
Regeneron Pharmaceuticals
REGN
.
ALNY, in collaboration with REGN, is advancing cemdisiran for the treatment of complement-mediated diseases. Currently, Alnylam and Regeneron are planning for the phase III development of cemdisiran in IgAN.
Apart from IgAN, Vera is evaluating atacicept in the phase III COMPASS study for the treatment of lupus nephritis.
Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus.
Vera’s portfolio currently does not have any approved products. Hence, in the absence of a marketed product, successful developments of its pipeline remain in key focus for the company.
Zacks Rank & Stock to Consider
Vera currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is
Syndax Pharmaceuticals, Inc.
SNDX
, which sports a Zacks Rank #1 (Strong Buy) at present. You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 14.5% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39%, on average.
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