The company now plans to apply for regulatory approval in the U.S. for Cemdisiran in the first quarter of 2026, pending discussions with the FDA.
Regeneron Pharmaceuticals, Inc. (REGN) announced on Tuesday that the late-stage trial evaluating its investigational Cemdisiran monotherapy in adults with generalized myasthenia gravis (MG) yielded positive results.
MG is a rare and chronic autoimmune disease where disrupted communication between nerves and muscles results in debilitating and potentially life-threatening muscle weakness. According to Regeneron, the disease impacts approximately 85,000 people in the U.S.
Both Cemdisiran and the combination of Cemdisiran and the approved antibody Pozelimab (cemdi-poze) demonstrated improvements in activities of daily functioning such as talking, eating, breathing, vision, and mobility at week 24. Cemdisiran showed numerically better results across all generalized myasthenia gravis-specific outcomes, the company said.
On Stocktwits, retail sentiment around REGN stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels. Shares of the company traded 2% higher at the time of writing.
A Stocktwits user believes that the stock may hit an all-time low soon.
The firm said that treatment-emergent adverse events (TEAEs) occurred in 69% of patients treated with Cemdisiran, 81% with cemdi-poze, and 77% with placebo. Serious TEAEs occurred in 3% of patients treated with Cemdisiran, 9% with cemdi-poze, and 14% with placebo, the company said. However, there were no treatment discontinuations due to adverse events through week 24 in the Cemdisiran arm, it added.
The company also said that there were no deaths during the 24-week placebo-controlled portion of the trial. During the extension period, however, one death due to pneumonia occurred in the Cemdisiran arm, and one death due to septic shock occurred in the combination arm. Both deaths occurred in patients who were on concomitant immunosuppressive therapies, Regeneron said.
The company now plans to apply for regulatory approval in the U.S. for Cemdisiran in the first quarter of 2026, pending discussions with the U.S. Food and Drug Administration (FDA).
REGN stock is down by 18% this year and by 51% over the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com<