Regeneron preps filings for myasthenia gravis drug

Regeneron could be just a few months away from filing for approval of a therapy for the neuromuscular disorder generalised myasthenia gravis (gMG), cemdisiran, which can be dosed just four times a year.

The US biotech has reported a positive phase 3 trial for the small interfering RNA (siRNA) therapy and is now preparing to file it for approval in the US in the first quarter of 2026 – assuming discussions with the FDA proceed as planned. The drug targets complement C5, a tried and tested drug target in gMG.

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