REGENXBIO INC. DL-,0001

REGENXBIO presented pipeline progress at the Global Healthcare Conference, with RGX-202 for Duchenne as its lead program and two large Phase III studies for Sirvac (wet AMD). The company reported pro‑forma cash of $313 million, which management says should fund operations through Q4 2027, and plans a pre‑BLA meeting in late 2024 and a BLA submission for RGX-202 in Q1 2025 with a possible FDA decision by late 2027. NAVSUNTI for Hunter syndrome faces regulatory questions pending outstanding imaging analyses, while Sirvac topline data are expected in Q4. REGENXBIO also highlighted its proprietary AAV manufacturing platform as a differentiator and sees potential balance‑sheet upside from additional milestone payments and product revenues. » More on de.investing.com

A new Regenxbio board member, Gregory Austin Ciongoli, purchased a total of 102,603 common shares worth about $949,381 on Aug. 26 and 27 on the open market. The insider purchase came immediately after his appointment as director on Aug. 25 and is being seen as a vote of confidence after the stock had been under heavy pressure. The premarket price rose about 5.7%, supported by the insider activity and upcoming clinical catalysts, including top-line data from the ATMOSPHERE and ASCENT studies in Q4 2026. » More on de.investing.com

REGENXBIO appointed Greg Ciongoli to its board of directors with immediate effect. Ciongoli is founder and managing partner of Adiumentum Capital Management, spent more than 16 years at The Baupost Group, and already serves on the boards of Atara Biotherapeutics and Zymeworks. The appointment coincides with the resignations of Jerry Karabelas and Jean Bennett and is intended to strengthen the board’s strategic succession planning. REGENXBIO develops gene therapies, including RGX-202 for Duchenne, Surabgen lomparvovec (in collaboration with AbbVie) for wet AMD and diabetic retinopathy, and RGX-121 and RGX-111 (in partnership with Nippon Shinyaku). » More on de.investing.com