$EXEL

Exelixis (EXEL) announced a 3-month FDA review extension for zanzalintinib, now targeting March 3, 2027. The FDA requested updated safety and efficacy data. The drug, combined with atezolizumab, aims to treat metastatic colorectal cancer. Exelixis' approval prospects hinge on the full STELLAR-303 study data, which showed a statistically significant survival benefit in the overall population but not in a key subgroup.

Exelixis (EXEL) reported slower-than-expected revenue growth for CABOMETYX due to delayed treatment decisions in NET. The company maintains 47% new-patient market share and plans to launch zanza for colorectal cancer if approved. Exelixis expects CABOMETYX generics in 2031 and is investing in pipeline and share repurchases, with $600M remaining under its authorization.

The FDA extended its review of Exelixis' NDA for zanzalintinib plus atezolizumab to treat metastatic colorectal cancer, moving the PDUFA action date to March 3, 2027. The extension followed updated safety and efficacy data submission, classified as a major amendment. The NDA is supported by the STELLAR-303 trial, which showed a median OS of 10.9 months vs 9.4 months with regorafenib.

Exelixis (EXEL) shares fell after the FDA delayed approval of its colon cancer treatment, a combination of zanzalintinib and Roche's (RHHBY) Tecentriq, by three months. Analyst Andy Hsieh from William Blair believes rejection is unlikely, as the treatment showed survival benefits.

Exelixis Inc (EXEL) shares dropped 3.5% premarket after the FDA extended its review of zanzalintinib by three months due to additional data. The new PDUFA action date is March 3, 2027. The delay may impact revenue projections and market expectations.

EXELIXIS, INC. (EXEL) filed an SEC Form 8-K — Other Events. Item 8.01. Other Events. Today, Exelixis, Inc. (Exelixis) announced that on September 10, 2026, the U.S. Food and Drug Administration (FDA) notified Exelixis that it had extended the review period for Exelixis’ new drug application (NDA) for zanzalintinib, in combination with ate

OmniAb (OABI) +13% to $5.43, raising 2026 cash flow guidance to $49M-$53M. Freenome (FRNM) +4% to $16.03 after FDA approvals. Exelixis (EXEL) +$59.11, Q2 profit $212M. LifeStance (LFST) +$13.15, Q2 revenue +26% to $435.4M. Faeth (FTH) +$40.89, Q2 loss $16M.

Beckerle Mary C sold 9,812 shares of EXELIXIS, INC. (EXEL) at $53.66 ($0.53M total) on 2026-08-10 under a Rule 10b5-1 trading plan.

EXELIXIS, INC. (EXEL) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Contacts: Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 csenner@exelixis.com Andrew Peters SVP, Strategy & Investor Relations Exelixis, Inc. 650-837-7248 apeters@exelixis.com Exelixis Announces Second Quarter 2026 Financial Results and Provides Cor

The article says U.S. healthcare stocks have held up in 2025 and highlights Krystal Biotech (KRYS), Exelixis (EXEL), and CVS Health (CVS) as outperformers. KRYS is driven by Vyjuvek and new approvals in Europe and Japan. EXEL’s focus is zanzalintinib for metastatic colorectal cancer. CVS cites health-insurance cost controls and a GLP-1 access platform. Market caps and gross margins are cited.