Regenxbio INC 8-K filings

REGENXBIO announced robust second-quarter 2026 financial results and operational highlights, including significant capital raises and positive clinical trial updates across its gene therapy pipeline.

REGENXBIO Inc. announced the pricing of a public offering of common stock and pre-funded warrants, expecting to raise approximately $100 million.

REGENXBIO announced the first patient dosed in a Phase IIb/III trial for diabetic retinopathy, triggering a $100 million milestone payment from AbbVie.

REGENXBIO Inc. announced the results of its 2026 Annual Meeting of Stockholders, including the election of directors, ratification of auditors, and approval of a stock option exchange program for non-executive employees.

REGENXBIO announced positive topline results from its pivotal Phase III AFFINITY DUCHENNE study of RGX-202 for Duchenne muscular dystrophy, achieving its primary endpoint with high statistical significance.

REGENXBIO Inc. has reached a settlement with GlaxoSmithKline LLC, agreeing to pay $10.0 million to resolve a dispute over sublicense fees.

REGENXBIO reported its fourth quarter and full year 2025 financial results, highlighting advancements in its gene therapy pipeline alongside regulatory challenges for its MPS programs.

REGENXBIO announced FDA clinical holds on its RGX-111 and RGX-121 gene therapy programs for rare diseases following a neoplasm case in an RGX-111 participant.

REGENXBIO reports Q3 2025 financial results and significant clinical milestones across its late-stage gene therapy programs for Duchenne, MPS II, wet AMD, and diabetic retinopathy.

REGENXBIO announced the FDA extended the PDUFA date for RGX-121, its Hunter syndrome gene therapy, to February 8, 2026, to review additional clinical data.

REGENXBIO reports strong operational progress across its gene therapy pipeline, including accelerated trial enrollment and successful FDA inspections, alongside a significant increase in cash position driven by strategic financing and new milestone payments.

REGENXBIO Inc. announced the results of its 2025 Annual Meeting of Stockholders, where all five proposals, including the election of directors, ratification of auditors, and approval of executive compensation and an equity incentive plan, were passed with strong shareholder support.

REGENXBIO has entered into a royalty bond agreement with Healthcare Royalty for up to $250 million, securing $150 million upfront and extending its cash runway into early 2027.

REGENXBIO announces its Q1 2025 financial results, highlighting significant revenue growth driven by the Nippon Shinyaku partnership and advancements in its gene therapy pipeline, including RGX-202 for Duchenne muscular dystrophy and clemidsogene lanparvovec for MPS II.

REGENXBIO announces fourth quarter and full year 2024 financial results, highlighting the BLA submission for clemidsogene lanparvovec (RGX-121) and strategic partnership with Nippon Shinyaku.

REGENXBIO Inc. announces the closing of its strategic partnership with Nippon Shinyaku to develop and commercialize gene therapies RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS) diseases in the United States and Asia.

REGENXBIO and Nippon Shinyaku have entered into an exclusive agreement to develop and commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I), respectively.

REGENXBIO has entered into a sales agreement to potentially raise up to $150 million through an at-the-market offering of its common stock.

REGENXBIO announced its third quarter 2024 financial results and provided updates on its gene therapy programs, including advancements in trials for Duchenne Muscular Dystrophy, wet AMD, diabetic retinopathy and MPS II.

REGENXBIO has appointed Mitchell Chan as its new Chief Financial Officer, effective immediately, while former CFO Vit Vasista will transition to an advisory role.

REGENXBIO granted restricted stock units to its Chief Medical Officer and Chief Scientific Officer to ensure leadership stability during a CEO transition.

REGENXBIO reports positive second quarter 2024 financial results, highlighted by advancements in their gene therapy pipeline and a strong cash position.

REGENXBIO has appointed Curran Simpson as its new President and CEO, effective July 1, 2024, while co-founder Kenneth T. Mills will transition to Chairman of the Board.

REGENXBIO Inc. held its annual meeting on May 31, 2024, where stockholders elected three Class III directors, ratified the appointment of PricewaterhouseCoopers LLP, and approved executive compensation.

REGENXBIO announced its first quarter 2024 financial results and provided updates on its gene therapy programs, highlighting progress towards pivotal trials and regulatory filings.

REGENXBIO has announced the pricing of an upsized public offering of common stock and pre-funded warrants, expected to generate approximately $140 million in gross proceeds.

REGENXBIO announced its fourth quarter and full year 2023 financial results, highlighting progress in its clinical pipeline and a strategic restructuring to reduce operating expenses.