Regenxbio Plunges 26% as FDA Halts Hunter Gene Therapy & Capricor Duchenne Decision Slips to Nov. 22 on Narrower Label

Regenxbio shares plunged 26% to $7.96 after the FDA placed a second clinical hold on RGX-121 (clemidsogene lanparvovec) — but the real trigger was the company abandoning its Hunter syndrome BLA resubmission. Spine MRI findings in five CAMPSIITE participants dosed three to six years ago surfaced through expanded monitoring Regenxbio built itself. Also: Roche's Genentech pays Hanmi $190 million up front, up to $2.3 billion total, for UCN2 analog HM17321 in muscle-sparing obesity; courts reject Merck and AstraZeneca challenges to Medicare price negotiation; the FDA action date lands for Biogen and Eisai's Leqembi Iqlik (lecanemab-irmb) subcutaneous starting dose; and Capricor's deramiocel Duchenne decision moves to November 22 behind a refined upper-limb indication.Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at thepharmacloseout.com.