Recent Updates — RGNX
REGENXBIO Inc. announced that director Kenneth T. Mills resigned from the Board, effective October 21, 2026, to focus on his new role as CEO of another company. The departure was not due to any disagreement regarding operations or policies. Concurrently, the Board appointed George Migausky as Chairman. Daniel Tassé stepped down as Lead Independent Director in accordance with governance guidelines but remains a Board member. REGENXBIO Inc. operates in the biotechnology industry, focusing on gene therapy and viral vector development.
REGENXBIO Inc. entered into a Settlement Agreement with The Trustees of the University of Pennsylvania, Sarepta Therapeutics, and Catalent to resolve patent infringement litigation regarding U.S. Patent Nos. 10,526,617 and 11,680,274 related to Sarepta's SRP-9001 (ELEVIDYS). Under the agreement, Sarepta will pay REGENXBIO $39.0 million within ten days of the effective date. The settlement terminates all ongoing patent litigation concerning these patents and includes a mutual release of claims and covenants not to sue regarding AAVrh74-based capsid products for ELEVIDYS. This resolution removes legal uncertainty surrounding key gene therapy intellectual property assets.
On August 25, 2026, REGENXBIO Inc.'s Board elected Gregory Ciongoli as a Class II director and appointed him to the Audit and Nominating committees. Concurrently, directors Jean Bennett and A.N. "Jerry" Karabelas resigned from the Board but will serve as advisors until February 2027. The Board reduced its size to nine members. Mr. Ciongoli received an initial equity award valued at $550,000 comprising stock options with a $8.91 exercise price and restricted stock units, along with annual retainers totaling $60,000. REGENXBIO is a biotechnology company focused on developing AAV gene therapies for rare and retinal diseases.
REGENXBIO Inc. announced that the FDA placed a clinical hold on its Investigational New Drug application for RGX-121, an investigational gene therapy for Mucopolysaccharidosis type II (MPS II). The hold follows asymptomatic spine MRI findings in five participants of the CAMPSIITE study. REGENXBIO does not expect to resubmit the Biologics License Application for RGX-121 in the near term. The company stated that patients remain clinically stable and attributed potential findings to the disease itself rather than the therapy. This regulatory setback impacts the MPS II program, though the firm maintains its pipeline focus on Duchenne muscular dystrophy and wet AMD candidates. REGENXBIO Inc. is a biotechnology company developing AAV gene therapies for rare and retinal diseases.
REGENXBIO Inc. reported second quarter 2026 financial results and operational highlights for the period ended June 30, 2026. The company achieved net income of $22.7 million, or $0.43 per share, compared to a net loss of $70.9 million in the prior year period. Revenues increased to $108.0 million from $21.4 million, driven by a $100.0 million development milestone payment from AbbVie for dosing the first patient in the NAAVIGATE diabetic retinopathy study. The company received over $200 million in new capital in July 2026, including approximately $108 million in net proceeds from an underwritten public offering and the AbbVie milestone payment, extending its cash runway into Q4 2027. Key clinical updates include the Phase III AFFINITY DUCHENNE trial meeting its primary endpoint with high statistical significance (p<0.0001) and a BLA submission for RGX-202 on track for Q3 2026 initiation. REGENXBIO is a biotechnology company focused on developing AAV gene therapies for rare, retinal, neuromuscular, and neurodegenerative diseases.
REGENXBIO Inc. entered into an underwriting agreement on July 16, 2026, to offer and sale of 10,003,889 shares of common stock at $9.00 per share and 1,111,111 pre-funded warrants at $8.9999 per warrant. The underwriters, including Morgan Stanley & Co. LLC, J.P. Morgan Securities LLC, Leerink Partners LLC and Mizuho Securities USA LLC, as representatives, exercised an option to purchase an additional 1,667,250 shares of common stock. The net proceeds from the offering, including the exercise of the option, are expected to be approximately $107.8 million. REGENXBIO is a biotechnology company focused on gene therapy development for rare and retinal diseases.