REGENXBIO Inc. 8K

REGENXBIO Inc. announced strong Q2 2026 financial results and major clinical and regulatory milestones across RGX-202, ABBV-RGX-314, and RGX-121, supported by over $200 million in new capital that extends its cash runway into Q4 2027.

On August 6, 2026, REGENXBIO Inc. reported its second quarter 2026 financial results and operational updates, highlighting pivotal Phase III success for RGX-202 in Duchenne muscular dystrophy with plans to initiate an accelerated approval BLA submission in Q3 2026, progress of surabgene lomparvovec (ABBV-RGX-314) for wet AMD and diabetic retinopathy with key pivotal readouts expected in Q4 2026 and global filings in 2027, and a positive FDA Type A meeting confirming that no additional studies are required for the RGX-121 BLA resubmission for Hunter syndrome targeted for Q3 2026; the company also disclosed receipt of over $200 million in July 2026 from an AbbVie milestone and an underwritten offering, extending its cash runway into Q4 2027, and reported a swing to Q2 2026 net income of $22.7 million driven largely by a $100 million development milestone payment.

Filing Facts

CIK

1590877

Ticker

RGNX

Form

8K

Source Type

fda

Accession

0001193125-26-336716

Alert Tier

7