November brings several closely watched FDA decisions, with Regeneron and its partner Alnylam’s therapy for generalized myasthenia gravis and Roche’s Gazyva for primary membranous nephropathy in the spotlight this week.
- Regeneron and Alnylam’s Cemdisiran showed significant improvements in daily functioning and muscle strength in a Phase 3 trial.
- Alnylam could receive royalties of up to 15% of worldwide sales of Cemdisiran.
- Roche awaits decisions on two drugs this month, including one for breast cancer.
The U.S. Food and Drug Administration (FDA) is set to rule on several key drugs in the penultimate month of 2026, with Capricor Therapeutics’ (CAPR) Deramiocel among the most closely watched decisions after the regulator extended its deadline by three months.
Regeneron Pharmaceuticals (REGN) and its partner Alnylam Pharmaceuticals (ALNY), along with Roche (RHHBY), are also awaiting FDA decisions on their respective autoimmune disease treatments this month, although exact dates have not been disclosed.
Regeneron And Alnylam Await FDA Decision On Cemdisiran
In June, the FDA granted Priority Review to Cemdisiran for generalized myasthenia gravis, an autoimmune disease that causes muscle weakness, with results expected any time this month.
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.
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.
Regeneron is developing Cemdisiran under license from Alnylam, which could receive royalties of up to 15% of worldwide sales.
Roche Eyes Two FDA Decisions In November
Roche is awaiting FDA’s 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.
In the Phase 3 MAJESTY trial involving 142 patients, 36.9% of Gazyva-treated patients achieved complete remission after two years, meeting the trial’s primary and secondary goals.
Separately, the FDA is also set to announce its decision on Roche’s 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).
How Have RHHBY, ALNY And REGN Stocks Fared So Far In 2026?
Retail sentiment for RHHBY on Stocktwits remained ‘bearish’ over the past 24 hours, while sentiment for REGN remained ‘extremely bullish’ and ‘bullish’ for ALNY.
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.
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(Exchange Rate: CHF1 = $1.22)