Highest-materiality recent filing
REGENXBIO appoints Greg Ciongoli to board; two directors retire effective Aug 25, 2026
Ciongoli elected as independent Class II director, term expires at 2029 annual meeting.
FDA clinical hold on REGENXBIO's RGX-121 for MPS II; BLA resubmission not expected near term
FDA clinical hold on RGX-121 after asymptomatic spine MRI findings in 5 CAMPSIITE study participants.
REGENXBIO Q2 net income $22.7M; RGX-202 BLA on track; cash runway to Q4 2027
Net income of $22.7M ($0.43 per share) vs net loss of $70.9M in Q2 2025; revenue $108.0M (incl. $100M AbbVie milestone).
REGENXBIO prices $100M public offering of common stock and pre-funded warrants
Offering of 10,003,889 shares at $9.00/share and 1,111,111 pre-funded warrants at $8.9999 each.
REGENXBIO doses first patient in Phase IIb/III DR trial; earns $100M milestone from AbbVie
First patient dosed in Phase IIb/III NAAVIGATE trial of sura-vec for diabetic retinopathy using suprachoroidal delivery.
REGENXBIO shareholders reject executive stock option exchange; approve non-executive program
At 2026 annual meeting, shareholders voted against executive stock option exchange: 21,021,531 against, 14,097,815 for.
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 stockholders elect four Class I directors, approve 2025 equity plan
Four Class I directors elected: Fox (27.99M for), Glucksmann (29.26M), Simpson (32.80M), Zachary (29.18M) until 2028.
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 grants RSUs to CMO and CSO to promote stability during CEO transition
On August 1, 2024, REGENXBIO granted 58,386 RSUs to EVP/CMO Stephen Pakola and 58,867 RSUs to EVP/CSO Olivier Danos.
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.
George Migausky, Kenneth T. Mills, David C. Stump elected as Class III directors with 39.1M, 39.3M, and 35.0M votes for, respectively.
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.
REGENXBIO cuts 15% workforce, focuses on three lead gene therapies; Q3 net loss $61.9M
Workforce reduction of ~15%, expected $100M cost savings over two years; cash runway extended into H2 2025.
REGENXBIO enters into $150M ATM equity offering agreement with BofA Securities
May offer and sell common stock up to $150M aggregate price under ATM Sales Agreement with BofA Securities.
REGENXBIO Q2 net loss $72.1M ($1.66/sh); revenue $20M; RGX-121 enrollment complete
Net loss widened to $72.1M vs $68.2M YoY; diluted EPS -$1.66.
REGENXBIO shareholders elect all three Class II director nominees at annual meeting
Jean Bennett, Jerry Karabelas, and Daniel Tassé elected as Class II directors with 30.3M, 35.5M, and 36.0M votes for, respectively.
REGENXBIO Q1 net loss $66.7M ($1.53/share); cash $473.5M; pipeline advances
Cash, equivalents and marketable securities $473.5M as of Mar 31, 2023; runway into 2025.
REGENXBIO Q4 net loss $59.9M ($1.38/share); revenue $31.3M vs $398.7M YoY; cash $565M
Full-year 2022 net loss $280.3M ($6.50/share) vs net income $127.8M in 2021.
REGENXBIO promotes Curran Simpson to COO, Shiva Fritsch to Chief Communications Officer
Curran Simpson appointed COO effective Jan 9, 2023; previously SVP, Chief Technology and Operations Officer since 2015.
REGENXBIO Q3 net loss $75.5M; cash $617M; RGX-314 BLA on track for 2024
Net loss of $75.5M ($1.75/share) vs $58.4M ($1.37/share) in Q3 2021; revenue $26.5M, down from $30.8M.
REGENXBIO Q2 net loss $68.2M, revenues up 48%; RGX-314 BLA on track for 2024
Net loss $68.2M ($1.58/share) vs $57.6M ($1.36) in Q2 2021; revenues $32.6M up 48% YoY.
REGENXBIO appoints Jennifer Zachary to board; annual meeting results ratified
Jennifer Zachary elected Class I director and Audit Committee member, effective June 3, 2022.
REGENXBIO Q1 net loss widens to $76.7M; delays RGX-202 Duchenne trial initiation to H1 2023
Net loss of $76.7M ($1.79/sh) vs $50.1M loss ($1.20/sh) in Q1 2021; revenue $22.2M up 17% YoY on Zolgensma royalties.
REGENXBIO settles Penn sublicense fees with $8M payment and $12M over 4 years; future fees removed
Company pays $8.0M to Penn for sublicense fees related to AbbVie collaboration agreement.
REGENXBIO director Daniel Abdun-Nabi will not stand for re-election at 2022 annual meeting
Daniel J. Abdun-Nabi informed REGENXBIO he will not stand for re-election at the 2022 annual meeting.
REGENXBIO reports Q4 net income $294M on AbbVie deal; cash $849M into 2025
Q4 2021 net income $294M ($6.87 basic EPS) vs net loss $46.2M in Q4 2020; revenue $398.7M (incl $370M AbbVie upfront).
47% of RGX-314 patients in Cohort 1 showed ≥2-step DRSS improvement at 6 months vs 0% control; up from 33% at 3 months.
REGENXBIO reports positive interim Phase I/II data for RGX-121 (MPS II) and RGX-111 (MPS I)
Both RGX-121 (13 pts) and RGX-111 (5 pts + single-patient IND) well-tolerated with no drug-related SAEs.
REGENXBIO settles arbitration with Abeona, receives $30M total payment
Abeona pays $20M upfront (received); $5M due at first anniversary; $5M due by third anniversary or specified transaction.
RGX-314 well tolerated across 50 patients in Cohorts 1-3; no drug-related SAEs.
REGENXBIO closes $370M upfront eye care collaboration with AbbVie for RGX-314 gene therapy
Upfront payment of $370M; potential for up to $1.38B in development, regulatory, and commercial milestones.
REGENXBIO Q3 net loss $58.4M; AbbVie collaboration for RGX-314 with $370M upfront
AbbVie collaboration: $370M upfront, up to $1.38B milestones, 50/50 U.S. profit share.
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.
On January 9, 2023, REGENXBIO Inc. (the “Company”) announced that Curran M. Simpson has been named Chief Operating Officer, effective immediately.
elected Jennifer Zachary as a Class I director of the Company and a member of the Audit Committee, effective immediately.
On March 14, 2022, Daniel J. Abdun-Nabi notified REGENXBIO Inc. (the “Company”) that he will not stand for re-election as a director of the Company at the end of his current term, which expires at the Company’s 2022 annual meeting of stockholders.
On September 3, 2021, Luke M. Beshar notified REGENXBIO Inc. (the “Company”) of his resignation from the Board of Directors of the Company (the “Board”), effective immediately.
On September 3, 2021, the Board, based upon the recommendation of the Nominating and Corporate Governance Committee, elected Jean Bennett, M.D., Ph.D., as a Class II director of the Company and a member of the Nominating and Corporate Governance Committee, effective immediately.
Max materiality 0.85 · Median 0.70 · Most common event earnings