REGENXBIO (NASDAQ:RGNX) Releases Quarterly Earnings Results, Misses Estimates By $0.31 EPS

REGENXBIO (NASDAQ:RGNX) announced its quarterly earnings results on Thursday. The biotechnology company reported ($1.30) EPS for the quarter, missing the consensus estimate of ($0.99) by ($0.31), FiscalAI reports. REGENXBIO had a negative net margin of 110.29% and a negative return on equity of 78.29%. The company had revenue of $30.34 million for the quarter.

Here are the key takeaways from REGENXBIO’s conference call:

• RGX‑202 (Duchenne) — Pivotal enrollment is complete, the company expects top‑line pivotal data in early Q2 2026 and will pursue a mid‑year FDA pre‑BLA meeting aiming for accelerated approval, citing robust Phase I/II functional results and a favorable safety profile.
• RGX‑314 (retina) with AbbVie — ATMOSPHERE and ASCENT (subretinal wet AMD) top‑line data are expected in Q4 2026, and the NAVIGATE Phase IIb/III trial for diabetic retinopathy is set to begin dosing next quarter, which will trigger a $100 million milestone from AbbVie.
• MPS programs (RGX‑121 / RGX‑111) — The company received a CRL for RGX‑121 and clinical holds for RGX‑111 and RGX‑121 after an SAE linked to AAV vector integration at the PLAG1 locus; REGENXBIO says the issues are addressable and is preparing a Type A meeting and BLA resubmission.
• Financials — Year‑end cash and marketable securities were $241 million, which the company says funds operations into early 2027 (potentially extendable into H2 2027 if the AbbVie milestone and other financing options materialize).

REGENXBIO Trading Down 4.6%

Shares of RGNX stock traded down $0.42 during trading hours on Thursday, hitting $8.72. 1,469,797 shares of the company’s stock were exchanged, compared to its average volume of 1,015,807. REGENXBIO has a 12-month low of $5.03 and a 12-month high of $16.19. The business’s 50 day simple moving average is $11.70 and its 200-day simple moving average is $11.41. The company has a market capitalization of $441.43 million, a PE ratio of -2.51 and a beta of 1.08.

Analyst Ratings Changes

A number of brokerages have issued reports on RGNX. HC Wainwright cut their target price on REGENXBIO from $34.00 to $32.00 and set a “buy” rating for the company in a research note on Tuesday, February 10th. Chardan Capital lowered their price target on shares of REGENXBIO from $52.00 to $50.00 and set a “buy” rating for the company in a report on Tuesday, February 10th. Morgan Stanley restated an “overweight” rating on shares of REGENXBIO in a research report on Thursday. The Goldman Sachs Group dropped their target price on shares of REGENXBIO from $14.00 to $12.00 and set a “neutral” rating on the stock in a report on Tuesday, February 10th. Finally, Wall Street Zen downgraded REGENXBIO from a “hold” rating to a “sell” rating in a report on Saturday, January 31st. Eight analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and an average target price of $27.80.

Institutional Investors Weigh In On REGENXBIO

Hedge funds have recently bought and sold shares of the business. Invesco Ltd. raised its stake in shares of REGENXBIO by 5.4% in the fourth quarter. Invesco Ltd. now owns 157,903 shares of the biotechnology company’s stock valued at $2,274,000 after acquiring an additional 8,023 shares during the period. Mercer Global Advisors Inc. ADV grew its holdings in REGENXBIO by 21.2% during the 4th quarter. Mercer Global Advisors Inc. ADV now owns 24,140 shares of the biotechnology company’s stock valued at $348,000 after purchasing an additional 4,224 shares during the last quarter. Vestal Point Capital LP purchased a new stake in REGENXBIO in the 4th quarter worth about $490,000. Virtus Investment Advisers LLC raised its position in REGENXBIO by 71.9% in the 4th quarter. Virtus Investment Advisers LLC now owns 19,181 shares of the biotechnology company’s stock worth $276,000 after purchasing an additional 8,026 shares during the period. Finally, Tudor Investment Corp ET AL bought a new stake in REGENXBIO in the fourth quarter worth about $350,000. Institutional investors own 88.08% of the company’s stock.

Key Headlines Impacting REGENXBIO

Here are the key news stories impacting REGENXBIO this week:

• Positive Sentiment: Pipeline catalysts remain: REGENXBIO outlined progress across late‑stage programs — RGX‑202 (Duchenne) topline pivotal results expected early Q2 2026; ABBV‑RGX‑314 (wet AMD) topline pivotal data expected Q4 2026; enrollment and new pivotal starts continue, and the company said it will engage the FDA on RGX‑121. REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
• Positive Sentiment: Clinical visibility: REGENXBIO announced presentations on RGX‑202 at the MDA Clinical & Scientific Conference (March 8–11), which could provide fresh data/clinical detail ahead of the pivotal readout. REGENXBIO Announces Presentations at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference
• Neutral Sentiment: Quarterly report and conference call: The company reported Q4 results and held an earnings call (release available); these materials include operational detail and management commentary investors can use to assess runways and capital needs. View Press Release
• Negative Sentiment: Earnings miss: RGNX reported a Q4 loss of $1.30/share vs. consensus ~($0.99) and revenue of $30.34M, missing expectations — results increase short‑term downside risk and raise questions about near‑term cash needs. Regenxbio (RGNX) Reports Q4 Loss, Lags Revenue Estimates
• Negative Sentiment: Class‑action litigation: Multiple firms have filed or are soliciting plaintiffs (Pomerantz, Rosen, Levi & Korsinsky) alleging securities law violations for the Feb 9, 2022–Jan 27, 2026 period; reminders and lead‑plaintiff deadlines increase legal overhang and could amplify downside. INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in REGENXBIO Inc. of Class Action Lawsuit and Upcoming Deadlines – RGNX
• Negative Sentiment: Additional law‑firm notices: Rosen Law Firm issued reminders about the April 14, 2026 lead‑plaintiff deadline (multiple pressings), and Levi & Korsinsky notified investors of a securities suit — these repeat notices keep legal risk front‑and‑center. ROSEN, A LEADING INVESTOR RIGHTS LAW FIRM, Encourages REGENXBIO, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – RGNX
• Negative Sentiment: Critical commentary: A SueWallSt piece highlights investor losses vs. earlier company promises, adding negative press that can dent sentiment. RGNX’S “TRANSFORMATIONAL” PROMISE BECAME A $2.40 LOSS FOR INVESTORS: SUEWALLST
• Negative Sentiment: Another securities‑suit notice (Levi & Korsinsky) reiterates the class period and potential claims, further elevating legal uncertainty. REGENXBIO Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – RGNX

REGENXBIO Company Profile

REGENXBIO Inc is a clinical‐stage biotechnology company specializing in the development of gene therapies using its proprietary NAV® AAV (adeno‐associated virus) platform. The company engineers next‐generation AAV vectors designed to deliver functional genes to targeted cells, aiming to address a range of rare genetic diseases and ocular, metabolic and neurologic disorders. REGENXBIO’s pipeline features several product candidates in various stages of preclinical and clinical development, including RGX-314 for wet age‐related macular degeneration, RGX-121 for mucopolysaccharidosis II (Hunter syndrome) and RGX-121 for other rare lysosomal storage diseases.

In addition to its internally funded programs, REGENXBIO has established partnerships with major biopharmaceutical companies to advance its NAV technology.