Exelixis review

The short version

Exelixis is what many small biotechs hope to become: a profitable company with one strong cancer drug. Cabometyx brought in $603.2 million of US sales in Q3 2026, and the company earned $218.1 million (Exelixis Q3 2026 results). Its challenge is the next decade: it needs a second big drug before generics arrive around 2030–31.

The latest FDA decision: delayed

On 11 September 2026 the FDA moved its decision on zanzalintinib in colorectal cancer from 3 December 2026 to 3 March 2027, after Exelixis sent updated data (OncLive). It is a three-month delay, not a rejection, and the shares fell only about 2% around the news, as our FDA Decision Calendar shows.

What it makes

Cabometyx is a pill that blocks several signals tumours use to grow and to build blood vessels. It is used for kidney cancer, where it is often paired with immunotherapy, as well as for liver and thyroid cancer and neuroendocrine tumours. Partners Ipsen and Takeda sell it outside the US and paid $51.8 million in royalties in Q3.

Zanzalintinib is the planned successor: a newer pill with a similar action but designed to leave the body faster, which should make side effects easier to manage. In the STELLAR-303 colorectal cancer trial, patients on zanzalintinib plus immunotherapy lived a median 10.9 months vs 9.4 on an older pill, with more serious side effects.

Is it really new?

Partly. Cabometyx is not a new kind of drug, but it became one of the strongest of its type. Zanzalintinib is an improved version rather than a breakthrough. A gain of about six weeks of life in colorectal cancer is real for patients who have run out of options, but it is not a large one. Its bigger potential lies in other trials, especially in kidney cancer.

The competition

In kidney cancer, Exelixis competes with Merck (Keytruda with Inlyta, or with Lenvima from Eisai). In colorectal cancer after earlier treatments, zanzalintinib would meet Fruzaqla, Lonsurf and Stivarga. The other competitors are the future generics. A settlement signed on 28 October 2026 lets Azurity market its version from December 2030, and MSN’s generic cannot get final FDA approval before January 2030, subject to appeals and a patent trial this month.

Money

The company expects $2.50–2.55 billion of revenue in 2026, a figure that does not include any zanzalintinib sales. It held about $1.4 billion of cash and marketable securities at the end of Q3 (Q3 2026 report). It returns much of its profit to shareholders: under the buyback launched in May 2026 it had spent $402.1 million by the end of Q3, at an average of $54.03 a share, and $3.2 billion since 2023. The shares trade around $72, close to their 52-week high.

Risks

• One product. Cabometyx is almost the whole business.
• The generic cliff. Without a strong successor, sales could fall sharply after 2030.
• Trial delays. STELLAR-304 has slipped several times and is now due in Q1 2027.
• A narrower label. A subgroup of colorectal cancer patients without liver tumours did not show a clear survival gain, and the FDA may take that into account.

Our take

Exelixis has a strong and profitable business with several years of protection left, which is unusual in this field. The stock is no longer cheap after a strong year, so the debate is about what happens after 2030. A positive STELLAR-304 result in Q1 2027 would matter as much as the FDA decision on 3 March, because kidney cancer is where zanzalintinib could really replace Cabometyx.