Binary FDA Catalysts 2027 — Dated PDUFA Only

Eight biotechs, each with a concrete FDA PDUFA target action date in 2027 confirmed by the company's own press release — no 'expected sometime' names. Binary outcomes: approval typically re-rates +30–80 %, a Complete Response Letter can halve the stock overnight, so each position is sized at 8–15 % with the two larger caps (Insmed, Axsome) as the anchors and the small caps (Dyne, Belite, Intellia, Immunome, Cogent) at 8–10 %. Rule: no adding on the way down, and the position is reviewed the day after the PDUFA date — win or lose, the thesis expires with the decision. Invalidation before the date: CRL, adcomm vote against, or a clinical hold. Not a diversified healthcare portfolio and not a buy-and-hold basket.