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Regeneron And Alnylam Await FDA Decision On Cemdisiran<\/p>\n
In June, the FDA\u00a0granted<\/a> Priority Review to Cemdisiran for generalized myasthenia gravis, an autoimmune disease that causes muscle weakness, with results expected any time this month.<\/p>\n The Phase 3 Nimble trial testing the drug showed that patients receiving Cemdisiran experienced a 4.5-point improvement in daily functioning after 24 weeks, compared with 2.2 points for those receiving placebo. About 76.6% of Cemdisiran-treated patients achieved a clinically meaningful improvement of at least three points, compared with 44.1% in the placebo group.<\/p>\n The treatment, administered through an injection once every three months, also met its secondary goal of improving muscle strength, with benefits observed by the second week of treatment.<\/p>\n Regeneron is developing Cemdisiran under license from Alnylam, which could receive royalties of up to 15% of worldwide sales.<\/p>\n Roche Eyes Two FDA Decisions In November<\/p>\n Roche is awaiting FDA\u2019s decision on Gazyva for primary membranous nephropathy, a rare autoimmune disease that damages the kidneys and can eventually lead to kidney failure. The regulator granted Priority Review in July. The drug could become the first FDA-approved treatment specifically for the disease.<\/p>\n In the Phase 3 MAJESTY trial involving 142 patients, 36.9% of Gazyva-treated patients achieved complete remission after two years, meeting the trial\u2019s primary and secondary goals.<\/p>\n Separately, the FDA is also set to announce its decision on Roche\u2019s experimental breast cancer drug Giredestrant on November 30. The drug is being developed for patients with early-stage, estrogen receptor-positive, HER2-negative breast cancer. Roche sees peak annual sales exceeding CHF3 billion ($3.65 billion).<\/p>\n How Have RHHBY, ALNY And REGN Stocks Fared So Far In 2026?<\/p>\n Retail sentiment for RHHBY on Stocktwits remained \u2018bearish\u2019 over the past 24 hours, while sentiment for REGN remained \u2018extremely bullish\u2019 and \u2018bullish\u2019 for ALNY.<\/p>\n Regeneron and Roche shares have gained 19.5% and 17.9% so far this year, respectively, while Alnylam Pharmaceuticals stock has slumped about 59%. Both Roche and Regeneron clocked their biggest monthly gains in October. ALNY shares have gained in just two months in 2026.<\/p>\n Also read:\u00a0Stocktwits Defense Watch: L3Harris, BA Report Record Backlogs, HII Raises FY2026 Shipbuilding Revenue Forecast<\/a><\/p>\n (Exchange Rate: CHF1 = $1.22)<\/p>\n![\"PDUFA.png\"\/](\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/11\/PDUFA_a5f49af42f.png\")
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