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Alnylam (ALNY) Posts Positive Data From IgA Nephropathy Study

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced positive top-line data from a phase II study evaluating its investigational pipeline candidate, cemdisiran, for the treatment of immunoglobulin A nephropathy ("IgAN").

Alnylam is developing cemdisiran, an investigational RNAi therapeutic targeting the C5 component of the complement pathway, in collaboration with Regeneron Pharmaceuticals (REGN - Free Report) .

Data from the above-mentioned study showed that treatment with cemdisiran led to a 37% mean reduction from base line in the 24-hour urine protein to creatinine ratio relative to placebo — the primary endpoint of the study.

The study data of secondary endpoints were similar to a therapeutic benefit of cemdisiran in IgAN. There were no significant drug-related safety signals.

Alnylam and Regeneron are planning for the phase III development of cemdisiran in IgAN.

Per the company, the data on cemdisiran demonstrates what is believed to be clinically meaningful reductions in proteinuria — which is an important prognostic factor in IgA nephropathy.

Though the overall safety and tolerability profile supports the clinical development of cemdisiran monotherapy in patients with IgAN, one death was reported in the cemdisiran arm related to a post-surgical complication. However, it was not related to the study drug.

Shares of Alnylam were down 3.2% on Thursday following the announcement of the news. The stock has plunged 20.4% so far this year compared with the industry’s decrease of 22.8%.

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Alnylam, in collaboration with Regeneron, is advancing cemdisiran for the treatment of complement-mediated diseases.

Regeneron is advancing a phase III study of cemdisiran and pozelimab combination for treating myasthenia gravis.

Alnylam records collaboration revenues from its collaboration with REGN.

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. (LPTX - Free Report) and Precision BioSciences, Inc. (DTIL - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.

Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.

Precision BioSciences’ loss per share estimates have narrowed 21.7% for 2022 and 31.4% for 2023 in the past 60 days.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.