HAE is one orphan disease that has changed from almost no effective treatment option to very crowded in very short period of time. In addition to those already approved, SNTS just resubmitted BLA this month for Ruconest, recombinant C1 esterase, for acute HAE, approved in EU already. VPHM is developing subQ version of Cinryze. As they noted in cc, FDA no longer considers HAE as unmet medical need, thus need large controlled trial from now on.
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