Regeneron’s Stock (REGN) Makes New Low: Trial Data Disappoints, Analyst Trims PT

Regeneron Pharmaceuticals stock (NASDAQ: REGN) is leading the Nasdaq lower today, down more than 18% through the first five minutes of the trading session. The company, once a darling of the biotech sector, now finds itself at a low ebb, as trial data disappoints.

After peaking at a 52-week high of $1,211.20 in August 2024, REGN shares have plunged to a new low at $493.26 this morning, a dramatic fall from grace. This drawdown underscores the mounting pressures facing the company, as both clinical and commercial developments challenge its growth narrative and investor confidence.

Today's negative catalyst comes from mixed results in Regeneron’s Phase 3 trials for itepekimab, developed in partnership with Sanofi. The AERIFY-1 trial met its primary endpoint, demonstrating a 27% reduction in moderate or severe acute exacerbations of COPD in former smokers compared to placebo at week 52—a clinically meaningful benefit.

However, the companion AERIFY-2 trial failed to replicate this success, not meeting its primary endpoint, although early benefits were observed. Both trials suffered from lower-than-expected exacerbation rates, likely due to enrollment during the COVID-19 pandemic, which may have reduced the statistical power needed to show a robust effect.

While the safety profile of itepekimab was consistent and adverse events were comparable to placebo, the lack of clear, repeatable efficacy has cast doubt on the drug’s commercial prospects.

This disappointment prompted Wells Fargo to downgrade Regeneron from Overweight to Equal Weight and lower its price target from $700 to $580, citing a lack of near-term catalysts and increased long-term challenges.

Looking to recent earnings, and results only compounded markets' concerns. The company reported a 4% year-over-year decline in total revenues to $3 billion, missing analyst expectations. The primary culprit was a pronounced drop in sales of Eylea, Regeneron’s flagship ophthalmology drug, which has long been the company’s main revenue driver. Eylea has come under intense competitive pressure from biosimilars, compounded bevacizumab, and the market’s gradual shift to the newer Eylea HD formulation. Lower net selling prices and loss of market share have further eroded margins.

While Regeneron’s collaboration with Sanofi on Dupixent continues to deliver strong sales and helped offset some of the revenue loss, it has not been enough to buoy the stock amid the broader commercial challenges. The company also faces higher operating expenses, squeezing profitability at a time when investors are demanding more robust growth.

Sentiment today is clearly at a low point, and Regeneron's stock has duly followed in making lows of its own.