The upbeat Phase‑3 read‑out for Cemdisiran (a quarterly‑subcutaneous MG monotherapy) has already removed the “clinical‑uncertainty” discount that previously capped Regeneron’s $30‑$35 b valuation. What now drives the near‑term price is the timing of the FDA’s regulatory decision. If the agency grants a standard‑track review (≈ 8 weeks after the BLA is submitted) and Regeneron can file its application this quarter, the market will price in a near‑term, high‑probability “approval at any price” scenario—supporting a 10‑12 % upside from today’s levels, especially on a break‑out of the 20‑day 20‑week high‑volume bullish pattern (currently 0.8 % of shares on the bid). Conversely, an extended “referral to advisory committee” or a standard 12‑month review window pushes the cash‑flow horizon out to 2026, keeping the upside tethered to a later‑dated catalyst. In that case, the equity will trade at a steeper risk‑discount, likely stalling at the $165‑$180 area (≈ 1.2× forward 2024‑25 EV/EBITDA) until a clearer regulatory timetable emerges.
Actionable take‑aways
- Short‑pull: If the BLA is filed this month and the FDA signals an 8‑week review, go long at current levels with a target of $190‑$200 (≈ 3‑4 % upside) and a stop just below the 50‑day EMA (~$175).
- Long‑pull: If the company issues a press‑release indicating a ≥ 12‑month review or a committee referral, stay defensive – trim exposure or place a tight stop at $175, as the upside will be deferred and the stock is likely to remain range‑bound until the next regulatory milestone.
In short, the FDA review clock is the decisive near‑term catalyst: a rapid, standard review lifts the valuation premium, while any protracted timeline caps upside and forces the market to price Regeneron on a longer‑term, higher‑risk trajectory.