Highest-materiality recent filing
REGENXBIO RGX-202 Phase III meets primary endpoint (p<0.0001); Q1 net loss $90.1M
Primary endpoint achieved: 93% of patients >10% microdystrophin expression at Week 12 (p<0.0001); average expression 71.1%.
REGENXBIO settles GSK sublicense fee dispute for $10M
Company will pay $10.0M to GSK within 3 business days for alleged underpayment of sublicense fees.
REGENXBIO Q4 net loss $67.1M; FDA holds on RGX-121/111; RGX-202 data expected Q2 2026
Q4 2025 net loss $67.1M ($1.30/sh) vs $51.2M loss ($1.01/sh) in Q4 2024; FY net loss $193.9M ($3.76/sh).
FDA rejects REGENXBIO's RGX-121 BLA for MPS II; company plans resubmission
FDA issued CRL on Feb 7, 2026 for RGX-121 (clemidsogene lanparvovec) to treat MPS II (Hunter syndrome).
FDA places clinical hold on REGENXBIO's RGX-111 and RGX-121 gene therapies after neoplasm case
Single neoplasm (intraventricular CNS tumor) found in 5-year-old asymptomatic patient 4 years post-RGX-111 dose; AAV vector integration detected near PLAG1 proto-oncogene.
REGENXBIO reports Q3 2025 net loss $61.9M; pipeline advances with key milestones
Net loss $61.9M ($1.20/sh) vs $59.6M ($1.17/sh) in Q3 2024; revenue $29.7M (+23% YoY).
FDA extends PDUFA date for RGX-121 BLA to February 8, 2026
PDUFA goal date extended from Nov 9, 2025 to Feb 8, 2026 for review of additional 12-month data from pivotal study (n=13).
REGENXBIO amends AbbVie deal; restructures $200M milestones, starts DR pivotal; Q2 net loss $70.9M
Amendment to AbbVie collaboration: $100M milestone upon first pt dosed in Phase IIb/III DR trial, additional $100M upon first pt in Phase III.
REGENXBIO closes up to $250M royalty bond with HCRx; $150M funded, cash runway into early 2027
Received $150M at closing; up to $250M total via three tranches, including $50M contingent on Zolgensma sales threshold by Apr 2027.
REGENXBIO Q1 net income $6.1M; revenue up 471% to $89M on Nippon Shinyaku deal
Net income $6.1M ($0.12 EPS) vs net loss $63.3M ($1.38 loss) in Q1 2024.
REGENXBIO reports Q4 net loss $51.2M; BLA for RGX-121 submitted, Nippon Shinyaku partnership closed
Net loss $51.2M ($1.01/sh) in Q4 2024 vs $62.9M; full year $227.1M ($4.59/sh) vs $263.5M. Revenue $83.3M vs $90.2M.
REGENXBIO closes strategic partnership with Nippon Shinyaku for MPS gene therapies
Partnership closed for development/commercialization of RGX-121 (MPS II) and RGX-111 (MPS I) in US and Asia.
REGENXBIO licenses RGX-121/RGX-111 to Nippon Shinyaku for $110M upfront, up to $700M milestones
Upfront $110M, milestones up to $700M ($40M dev/reg, $660M sales), plus double-digit royalties on net sales in U.S. and Asia.
First five patients in Phase I/II showed stable/improved function on NSAA and timed tests, exceeding external natural history controls.
REGENXBIO Q3 net loss $59.6M; cash $278.6M; RGX-202 pivotal trial initiation expected this month
Net loss of $59.6M ($1.17 EPS) vs $61.9M ($1.41 EPS) in Q3 2023.
REGENXBIO appoints Mitchell Chan as CFO; Vittal Vasista steps down after 15 years
Mitchell Chan appointed EVP, CFO effective Sept. 16, 2024; base salary $490K, 40% bonus target, $3M equity grant (75% options, 25% RSUs).
REGENXBIO Q2 net loss $53M; advances RGX-202 pivotal and RGX-121 BLA
Q2 2024 net loss of $53.0M ($1.05 per share); revenue $22.3M (up 12% YoY) on Zolgensma royalties.
REGENXBIO appoints COO Curran Simpson as CEO; founder Kenneth Mills becomes Chairman
Curran Simpson, former COO, appointed President and CEO effective July 1, 2024; also named to Board.
REGENXBIO Q1 net loss $63.3M; RGX-202 selects pivotal dose; cash $380.5M
Net loss $63.3M ($1.38 diluted EPS) vs $66.7M ($1.53) YoY; revenue $15.6M, down from $19.1M.
REGENXBIO prices upsized public offering of common stock and pre-funded warrants at $23.00 per share
Offering includes 4,565,260 shares at $23.00 and 1,521,740 pre-funded warrants at $22.9999, with gross proceeds ~$140M.
REGENXBIO reports Q4 net loss $62.9M, cash $314M; pipeline milestones for 2024
Q4 net loss $62.9M ($1.43/sh); full year net loss $263.5M ($6.02/sh); 2023 revenue $90.2M vs $112.7M in 2022.
On September 16, 2024, the board of directors (the “Board” of REGENXBIO Inc. (the “Company”) appointed Mitchell Chan as Executive Vice President, Chief Financial Officer and Principal Accounting Officer, effective immediately.
the Board accepted the resignation of Vittal Vasista from his position as Executive Vice President, Chief Financial Officer and Principal Accounting Officer, effective as of September 16, 2024
Daniel Tassé was appointed as the Company's Lead Independent Director, succeeding Jerry Karabelas.
the Company also announced that the Board appointed Curran M. Simpson as President and Chief Executive Officer, effective as of July 1, 2024.
In connection with his appointment, the Board appointed Mr. Simpson as a Class I director, effective July 1, 2024
Daniel Tassé was appointed as the Company's Lead Independent Director, succeeding Jerry Karabelas.
accepted the resignation of Kenneth T. Mills from his position as President and Chief Executive Officer of the Company, effective July 1, 2024.
Max materiality 0.85 · Median 0.70 · Most common event earnings