REGENXBIO Inc. (NASDAQ:RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand.
The move follows a regulatory update that has raised concerns among investors. The U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapies.
FDA Holds REGENXBIO’s Gene Therapy Programs
The FDA’s decision affects REGENXBIO’s RGX-111 and RGX-121 programs, which are aimed at treating rare genetic disorders.
The clinical hold was prompted by a case of neoplasm detected in a participant treated with RGX-111, leading to scrutiny over the safety of both therapies.
RGX-111 is under development for MPS I, also known as Hurler syndrome, which is an inherited condition caused by a faulty gene. Children with Hurler syndrome lack an enzyme that the body needs to digest sugar.
A neoplasm is a new and abnormal growth of tissue in a part of the body, especially as a characteristic of cancer.
The FDA also placed a clinical hold on RGX-121 for MPS II, also known as Hunter Syndrome, citing the similarities in products, study populations, and shared risk between the clinical studies.
Children with Hunter syndrome lack an enzyme called iduronate 2-sulfatase that the body needs to digest sugar. As a result, undigested sugar molecules build up in the body.
In addition, the company reported that no evidence of neoplasm has been found in other participants treated with RGX-111 or RGX-121.
REGENXBIO’s CEO expressed surprise at the FDA’s decision, emphasizing the favorable safety profile of RGX-121 based on data from over 30 patients treated, some nearly seven years ago.
RGNX Stock Faces Short-Term Weakness
The stock is currently trading 23.4% below its 20-day simple moving average (SMA) and 9.9% below its 100-day SMA, demonstrating significant short-term weakness. Over the past 12 months, shares have increased by 44.41% and are currently positioned closer to their 52-week lows than highs.
The RSI is at 45.56, which is considered neutral territory, while the MACD is below its signal line, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.
- Key Resistance: $12.00
- Key Support: $11.00
Upcoming Earnings: Analysts’ Eyes on RGNX
Investors are looking ahead to the next earnings report on March 12, 2026.
- EPS Estimate: Loss of 86 cents (Up from $-1.01 YoY)
- Revenue Estimate: $50.09 million (Up from $21.21 million YoY)
The stock carries a Buy Rating with an average price target of $31.38. Recent analyst moves include:
- Stifel: Buy (Raises Target to $45.00).
- Leerink Partners: Outperform (Raises Target to $20.00).
- Chardan Capital: Buy (Maintains Target to $52.00).
RGNX Scores High on Benzinga Edge Momentum
Below is the Benzinga Edge scorecard for REGENXBIO, highlighting its strengths and weaknesses compared to the broader market:
- Momentum: Bullish (Score: 91.62) — Stock is outperforming the broader market.
The Verdict: REGENXBIO’s Benzinga Edge signal reveals a strong momentum score of 91.62, indicating that the stock is currently outperforming the broader market despite the recent regulatory challenges. Investors should remain cautious as the company addresses the FDA’s concerns while monitoring the stock’s performance closely.
RGNX Price Action: Regenxbio shares were down 20.21% at $10.70 at the time of publication on Wednesday, according to Benzinga Pro data.
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