Exelixis Inc Stock Price, News & Analysis

Exelixis (NASDAQ: EXEL) has announced positive results from a subgroup analysis of the phase 3 CABINET study evaluating cabozantinib in patients with gastrointestinal neuroendocrine tumors (GI NET). The analysis showed that cabozantinib reduced the risk of disease progression or death by 50% compared to placebo.

The study included 116 patients, with primary tumor locations predominantly in the ileum/cecum (54%) and small intestine (20%). Median progression-free survival was 8.5 months with cabozantinib versus 5.6 months with placebo. One patient achieved partial response with cabozantinib, while 48 patients achieved stable disease compared to 30 with placebo.

The FDA is currently reviewing Exelixis's supplemental New Drug Application for cabozantinib in advanced neuroendocrine tumors, with a target action date of April 3, 2025. Common grade 3/4 adverse events included hypertension (19%), diarrhea (13%), and fatigue (10%).

Exelixis (NASDAQ: EXEL) has announced preliminary fiscal year 2024 results and 2025 guidance. The company achieved approximately $1.805 billion in preliminary U.S. net product revenues for FY2024 from its cabozantinib franchise, with total revenues reaching ~$2.165 billion.

For FY2025, Exelixis projects net product revenues between $1.95-$2.05 billion and total revenues of $2.15-$2.25 billion. The guidance includes a 2.8% price increase for CABOMETYX effective January 2025 but excludes potential revenues from NET indication pending FDA approval.

The company expects key developments in 2025, including a potential FDA approval for CABOMETYX in neuroendocrine tumors (NET) with a PDUFA date of April 3, 2025, and multiple data readouts for zanzalintinib. R&D expenses are projected at $925-975 million for 2025, with SG&A expenses estimated at $475-525 million.

Exelixis (EXEL) announced that the FDA has removed the supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) from discussion at an upcoming Oncologic Drugs Advisory Committee meeting. The sNDA seeks approval for treating previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET) in adults. The FDA continues to review the application with a Prescription Drug User Fee Act action date of April 3, 2025.

Exelixis (NASDAQ: EXEL) has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference. The company's President and CEO, Michael M. Morrissey, Ph.D., will deliver a corporate overview presentation on Monday, January 13, 2025, at 5:15 p.m. PT / 8:15 p.m. PT.

The presentation will be accessible via webcast through the company's website at www.exelixis.com, specifically on the Event Calendar page under the Investors & News section. For those unable to attend live, replay access will remain available on the same platform for a minimum of 30 days following the presentation.

Sairopa B.V. has achieved a significant milestone in its partnership with Exelixis (NASDAQ: EXEL) regarding ADU-1805, an anti-SIRPα antibody for cancer treatment. The collaboration has generated substantial payments, including a $40 million upfront payment, $35 million for IND clearance, and an additional $35 million in clinical development milestones. The agreement grants Exelixis an exclusive option for worldwide development and commercialization rights following phase 1 clinical studies data review.

ADU-1805 is currently in a first-in-human phase 1 study across the U.S. and Europe, evaluating both monotherapy and combination treatment with pembrolizumab. The partnership combines Exelixis' oncology expertise with Sairopa's immunotherapy capabilities.

Exelixis (NASDAQ: EXEL) has announced its participation in two major healthcare investor conferences this December. The company will present at the Piper Sandler 36th Annual Healthcare Conference in New York City on December 3 at 8:30 a.m. ET, and at the Citi 2024 Global Healthcare Conference in Miami on December 4 at 1:45 p.m. ET. Both fireside chats will be accessible via webcast on www.exelixis.com under the Investors & News section, with replays available for at least 30 days after the events.

Exelixis (EXEL) announced that the FDA will discuss their supplemental New Drug Application (sNDA) for CABOMETYX® at an Oncologic Drugs Advisory Committee meeting in March 2025. The application seeks approval for treating previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors. The FDA has set a target action date of April 3, 2025, following the orphan drug designation granted in August 2024.

The sNDA is supported by the phase 3 CABINET trial, which demonstrated significant improvements in progression-free survival compared to placebo, leading to early trial termination and allowing placebo patients to cross over to CABOMETYX® treatment. Final results confirmed statistically significant benefits across all clinical subgroups.

Exelixis (Nasdaq: EXEL) will participate in fireside chats at three investor conferences in November. The events are:

• Guggenheim’s Inaugural Healthcare Innovation Conference on November 12 at 9:00 a.m. ET in Boston.
• Stifel 2024 Healthcare Conference on November 18 at 10:20 a.m. ET in New York City.
• Jefferies London Healthcare Conference on November 19 at 10:30 a.m. BST in London, UK.

Webcasts of these presentations will be accessible via the Exelixis website under the Event Calendar page in the Investors & News section. Replays will be available for 30 days.

Exelixis (EXEL) reported strong Q3 2024 financial results with total revenues of $539.5 million, including net product revenues of $478.1 million from its cabozantinib franchise. The company achieved GAAP diluted EPS of $0.40 and non-GAAP diluted EPS of $0.47. Following strong commercial performance, Exelixis increased its 2024 guidance for total revenues to $2.150-$2.200 billion. The company received a favorable ruling on cabozantinib patent litigation and expanded its zanzalintinib development program through a new collaboration with Merck.