Autolus Surges on Strong 2026 Revenue Forecast
FDA & Biotech

Autolus Surges on Strong 2026 Revenue Forecast

Company signals confidence in its lead cancer therapy, obe-cel, ahead of a potential FDA approval later this year, causing shares to jump.

Shares of Autolus Therapeutics (NASDAQ: AUTL), a clinical-stage biopharmaceutical company, climbed in early trading Monday after it released strong preliminary fourth-quarter revenue and issued an ambitious full-year 2026 forecast contingent on the approval of its lead drug candidate.

The London-based firm announced it expects to generate between $120 million and $135 million in revenue for the full-year 2026, a significant increase over the estimated $75 million for 2025. This guidance, representing roughly 70% year-over-year growth at the midpoint, signals management's high expectations for the commercial launch of its CAR-T cell therapy, obecabtagene autoleucel, or obe-cel.

In the more immediate term, Autolus reported preliminary fourth-quarter 2025 revenue of approximately $24.0 million, comfortably beating analyst consensus estimates of $21.3 million. Perhaps more significantly, the company stated in its corporate update that it anticipates achieving a positive gross margin in 2026, a critical inflection point on its path to profitability.

Autolus is at a pivotal moment as it seeks to transition from a research-and-development focused entity to a commercial-stage company. Its future rests heavily on obe-cel, an investigational therapy for adult patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (ALL). The treatment is currently under review by the U.S. Food and Drug Administration (FDA), with a regulatory decision expected in the second half of 2026.

A positive FDA decision would make obe-cel a key new player in a challenging therapeutic area. Adult ALL has a poor prognosis, and new, more effective treatments are in high demand. CAR-T therapies like obe-cel represent a personalized approach to fighting cancer, engineering a patient's own T-cells to recognize and attack malignant cells.

Investors reacted positively to the financial projections, which provide the first concrete glimpse into the potential revenue scale of a successful obe-cel launch. The stock's move reflects growing optimism not just about the drug's clinical profile, but also its commercial viability.

Despite the recent surge, Wall Street analysts appear to see substantial further upside. The consensus 12-month price target for Autolus sits at $9.63, according to data from getMarketData, suggesting that analysts believe the stock could more than quadruple if the company successfully executes on its commercial strategy following an FDA approval.

The company's focus now shifts entirely to manufacturing readiness and commercial launch preparations. The optimistic revenue guidance indicates that these plans are well underway. However, the entire bullish thesis remains dependent on the FDA's verdict. While the newly issued forecast de-risks the commercial outlook to a degree, the regulatory decision remains the single most important catalyst on the horizon for Autolus and its investors.