REGENXBIO (NASDAQ:RGNX) Announces Earnings Results

REGENXBIO (NASDAQ:RGNX) announced its quarterly earnings data on Thursday. The biotechnology company reported ($1.30) EPS for the quarter, missing the consensus estimate of ($1.01) by ($0.29), FiscalAI reports. The business had revenue of $30.34 million for the quarter, compared to analyst estimates of $45.48 million. REGENXBIO had a negative net margin of 113.75% and a negative return on equity of 103.12%.

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 Stock Performance

Shares of NASDAQ RGNX opened at $8.65 on Friday. The company’s fifty day moving average price is $11.47 and its 200 day moving average price is $11.42. REGENXBIO has a 1 year low of $5.03 and a 1 year high of $16.19. The company has a market capitalization of $437.86 million, a PE ratio of -2.30 and a beta of 1.08.

Analysts Set New Price Targets

Several research analysts recently issued reports on the stock. Wall Street Zen cut shares of REGENXBIO from a “hold” rating to a “sell” rating in a report on Saturday, January 31st. UBS Group reaffirmed an “overweight” rating and issued a $18.00 price target on shares of REGENXBIO in a report on Tuesday, February 10th. Robert W. Baird set a $27.00 price objective on REGENXBIO in a research note on Tuesday, February 10th. Morgan Stanley reduced their price objective on REGENXBIO from $18.00 to $17.00 and set an “overweight” rating for the company in a research note on Thursday. Finally, Leerink Partners boosted their price objective on REGENXBIO from $16.00 to $20.00 and gave the company an “outperform” rating in a report on Monday, December 15th. Eight research analysts have rated the stock with a Buy rating, one has given a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat, the stock presently has an average rating of “Moderate Buy” and an average price target of $27.70.

Trending Headlines about REGENXBIO

Here are the key news stories impacting REGENXBIO this week:

• Positive Sentiment: Pipeline catalysts approaching — management reported that RGX‑202 (Duchenne) has topline pivotal results expected early Q2 2026, RGX‑314 (sura‑vec / wet AMD) has topline pivotal data expected Q4 2026, a pivotal Phase IIb/III diabetic retinopathy trial has started dosing, and the company plans to engage the FDA on a path forward for RGX‑121. These upcoming readouts are potential upside catalysts if data are positive. REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
• Neutral Sentiment: Company provided earnings materials and management commentary — full Q4 2025 earnings call transcripts and highlights are available for investors to review for program timelines, cash guidance and cost trajectory. Use these to reassess runway and probability of late‑stage success. REGENXBIO (RGNX) Q4 2025 Earnings Call Transcript
• Negative Sentiment: Q4 results missed expectations — REGENXBIO reported EPS of ($1.30) vs. consensus (~($0.99)) and revenue of $30.34M, highlighting continued losses and pressure on near‑term financials. The miss increases scrutiny on execution and funding assumptions ahead of costly pivotal readouts. Regenxbio (RGNX) Reports Q4 Loss, Lags Revenue Estimates
• Negative Sentiment: Multiple law firms are soliciting lead‑plaintiff investors and reminding shareholders of an April 14, 2026 deadline in a securities class action covering Feb 9, 2022–Jan 27, 2026. The flurry of Rosen, Schall, Faruqi, Pomerantz and others’ notices signals heightened litigation risk and potential future liabilities or settlements that could pressure the stock. ROSEN, A LEADING LAW FIRM, Encourages REGENXBIO, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – RGNX
• Negative Sentiment: Sector‑wide regulatory caution — recent FDA reversals and tougher review posture for experimental drugs are spooking investors in gene‑therapy and biotech names; this increases binary outcome risk ahead of REGENXBIO’s pivotal readouts. FDA reversals leave investors worrying about the fates of other experimental drugs

Institutional Inflows and Outflows

A number of large investors have recently modified their holdings of the company. AQR Capital Management LLC boosted its stake in shares of REGENXBIO by 2,247.7% during the 1st quarter. AQR Capital Management LLC now owns 620,595 shares of the biotechnology company’s stock worth $4,437,000 after acquiring an additional 594,161 shares in the last quarter. State Street Corp increased its stake in shares of REGENXBIO by 15.2% in the 4th quarter. State Street Corp now owns 2,286,736 shares of the biotechnology company’s stock valued at $32,929,000 after purchasing an additional 301,858 shares in the last quarter. GSK plc acquired a new position in REGENXBIO in the 4th quarter worth about $3,909,000. Jane Street Group LLC raised its holdings in REGENXBIO by 151.1% in the 1st quarter. Jane Street Group LLC now owns 414,067 shares of the biotechnology company’s stock worth $2,961,000 after purchasing an additional 249,156 shares during the period. Finally, Squarepoint Ops LLC boosted its position in REGENXBIO by 2,049.0% during the second quarter. Squarepoint Ops LLC now owns 219,288 shares of the biotechnology company’s stock worth $1,800,000 after purchasing an additional 209,084 shares in the last quarter. Institutional investors and hedge funds own 88.08% of the company’s stock.

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.