Exelixis delays cancer-drug review: what it means for Exelixis stock

Published on 10/07/2026 at 01:15 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Second-quarter revenue reached USD 628.69 million. For Exelixis stock, the FDA decision is now due March 3, 2027 for colorectal cancer.

EXEL, US30161Q1040, Illustration mit AI erstellt.

Exelixis (US30161Q1040) faces a three-month delay for zanzalintinib's FDA review, with the decision now due March 3, 2027. Zacks reported on September 24, 2026 that the FDA requested more information after updated safety and efficacy data triggered a major amendment.

The review moves to March 2027

The original target action date was December 3, 2026. The revised March 3, 2027 date pushes the potential regulatory decision for zanzalintinib in metastatic colorectal cancer into the first quarter of 2027, keeping the drug under review while Exelixis prepares for a possible launch.

Yahoo Finance reported on September 11, 2026 that the extension followed an FDA information request and Exelixis' submission of updated data. The agency classified the submission as a major amendment.

What the delay means for growth

The regulatory timetable matters because zanzalintinib is intended to become Exelixis' second commercial oncology franchise. Management lowered the midpoint of its 2026 revenue guidance by USD 50.00 million in the second quarter, citing a slower ramp for the neuroendocrine tumor indication.

The existing cabozantinib business remains the financial base for that pipeline investment. In the second quarter of 2026, U.S. CABO franchise net product revenue grew 10.00 percent year over year to USD 573.00 million, while global franchise revenue grew 13.00 percent year over year to USD 806.00 million, according to the Yahoo Finance transcript of the August 5, 2026 earnings call.

Revenue reaches USD 628.69 million

Exelixis reported total revenue of USD 628.69 million and GAAP net income of USD 212.05 million in the second quarter of 2026. Diluted GAAP earnings per share were USD 0.82, while cash and marketable securities stood at USD 1.40 billion at June 30, 2026, according to Yahoo Finance.

Nasdaq quote stays below yearly high

Exelixis was last at USD 58.33 on Nasdaq on October 6, 2026 at 4:00 p.m. ET, against a 52-week range of USD 33.76 to USD 61.14 and a market capitalization of USD 14.7 billion. The prior close at Lang & Schwarz was EUR 51.58 on October 5, 2026.

The further course of trading is shown by the continuously updated real-time quote of Exelixis stock.