What is the estimated market size for a subcutaneous Myasthenia Gravis therapy and how might this trial success translate into revenue growth?

Estimated market size

Generalized Myasthenia Gravis (MG) affects roughly 50‑150 patients per million worldwide, translating into about 200‑250 k diagnosed individuals globally. The existing MG therapeutic market—comprised of anticholinesterase agents, steroids, and the complement‑inhibitor eculizumab (Soliris)—is currently valued at roughly $1.5‑$2 billion per year. A quarterly‑subcutaneous product that offers durable disease‑control could realistically capture 15‑20 % of that market to‑pay, suggesting a peak‑sales potential in the $250‑$350 million range (U.S. alone) and $400‑$600 million globally once fully commercialised.

Revenue translation & trading implications

Regeneron’s cemdisiran, by meeting both the primary and key secondary endpoints, moves the product from a “pipeline‑only” to a commercially viable asset. Assuming FDA approval in 2025, a 3‑year lag to market entry would let the therapy start generating $300‑$500 million in incremental revenue by 2027‑2028 under a mid‑price scenario (≈ $12‑$15 k per patient per year). This upside is additive to Regeneron’s existing portfolio (e.g., Dupixent), nudging its total 2025‑2028 revenue growth from ~10 % to 13‑14 % CAGR.

From a technical standpoint, REGN is trading near its 52‑week high on modest volume, reflecting a “buy‑the‑news” rally. The catalyst—potential NDA filing—creates a classic “breakout” pattern; a pull‑back to the 200‑day moving average (≈ $540) could offer a lower‑‑risk entry point. Given the modest market size but strong pricing power and limited competition (no other long‑acting subcutaneous complement inhibitors in the pipeline), a 5‑10 % upside in the next 3‑6 months appears priced in.

Actionable take‑away

‑ Long REGN on any corrective dip to the 200‑day MA, targeting a 5‑10 % upside as FDA+ approval news solidifies.

‑ Monitor for the Regeneron‑AstraZeneca partnership announcement and NDA filing timeline (mid‑2025); any delay or additional data read‑out could trigger a short‑term sell‑off.

‑ Risk: competitive pressure from upcoming oral complement inhibitors and potential safety‑profile disclosures; keep a stop‑loss around 8 % below entry.