REGENXBIO Swings to Profit as AbbVie Milestone Hits
REGENXBIO posted net income of $22.7 million after AbbVie paid a $100.0 million dosing milestone that pushed quarterly revenue to $108.0 million.
REGENXBIO (RGNX) reported net income of $22.7 million, or $0.43 a share, for the second quarter of 2026, reversing a year-earlier net loss of $70.9 million as a $100.0 million milestone payment from AbbVie flowed through its top line.
The gene-therapy company, which develops treatments for rare and neurodegenerative diseases, triggered the payment in June when it dosed the first patient in the Phase IIb/III NAAVIGATE study evaluating its sura-vec diabetic retinopathy program, a milestone AbbVie funded after REGENXBIO advanced the program from site activation earlier in the year.
Total revenue rose to $108.0 million from $21.4 million a year earlier, a roughly 405% increase driven mainly by that milestone. License and royalty revenue climbed to $103.8 million from $18.5 million, while service revenue rose to $4.2 million from $2.9 million. The gain came even as royalty revenue tied to Novartis's ZOLGENSMA fell $16.7 million after the expiration of licensed U.S. patents in January 2026; Novartis's follow-on product ITVISMA, launched in the U.S. in the first quarter, now generates royalties for REGENXBIO under patent protection running to 2037.
Income from operations flipped to a $29.3 million gain from a $63.3 million loss, aided by the milestone revenue and by lower spending. Research and development expenses declined to $56.1 million from $59.5 million on reduced manufacturing and clinical-trial costs for the sura-vec and RGX-121 pivotal programs, while general and administrative expenses rose to $21.6 million from $19.9 million on personnel and commercialization costs. The six-month net loss still widened slightly to $67.3 million from $64.8 million, reflecting the loss recorded earlier in the year before the milestone hit.
Two of REGENXBIO's clinical programs advanced toward regulatory filings during the quarter. RGX-121, the company's therapy for MPS II, cleared a reversal that began with a Complete Response Letter from the FDA in February 2026: the agency lifted a clinical hold in the first quarter and, in July, held a positive Type A meeting reaffirming that no additional studies are needed, putting a BLA resubmission on track for the third quarter of 2026. RGX-202, the company's Duchenne muscular dystrophy candidate, met its primary endpoint with a p-value below 0.0001 in topline pivotal data reported in the first quarter, and its confirmatory study completed enrollment ahead of schedule by the anchor quarter, with a BLA submission also targeted for the third quarter and potential accelerated approval guided to the second half of 2027. REGENXBIO also disclosed plans for a new ex-U.S. randomized-controlled trial, AFFINITY RISE, to support global submissions for RGX-202, expected to begin in the first half of 2027.
Cash, cash equivalents and marketable securities fell to $105.5 million as of June 30 from $240.9 million at the end of 2025 as the company funded first-half operations. That balance was replenished after the quarter closed: the $100.0 million AbbVie milestone and roughly $108.0 million in net proceeds from a July underwritten offering brought pro forma cash to approximately $313 million. Shares outstanding rose to 54.164 million from 50.892 million, a figure that does not yet fully reflect the July offering.
The post-raise cash position funds operations into the fourth quarter of 2027, a runway figure it did not disclose in its first-quarter or year-end 2025 releases. Royalty monetization liabilities shifted toward the long end of the balance sheet, with the current portion falling to $26.8 million from $39.6 million and the long-term portion rising to $154.7 million from $147.4 million.