Exelixis, Inc. - Common Stock (EXEL)

Exelixis, Inc. (Nasdaq: EXEL) announced today that its fourth quarter and full year 2024 financial results will be released on Tuesday, February 11, 2025 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or in combination with atezolizumab (Tecentriq®) in patients with previously-treated metastatic colorectal cancer (CRC). The findings will be presented during Poster Session C: Cancers of the Colon, Rectum and Anus, at 7:00 a.m. PT on January 25 at the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium (ASCO GI 2025).

Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the phase 3 CABINET pivotal study of patients with extra-pancreatic neuroendocrine tumors (epNET) arising in the gastrointestinal (GI) tract. The analysis showed cabozantinib was associated with an improvement in progression-free survival (PFS) compared with placebo in patients with advanced GI neuroendocrine tumors (NET), which was a subgroup of the epNET cohort. These results are being presented today during Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract, at 11:30 a.m. PT on January 24 at the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium (ASCO GI 2025).

Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fiscal year 2024, provided financial guidance for fiscal year 2025 and delivered an update on its business. Exelixis anticipates 2025 will be a year of clinical and regulatory execution and continued growth for its cabozantinib franchise, as well as multiple data readouts for zanzalintinib and across its diversified pipeline of small molecules and biotherapeutics with the potential to improve standards of care for patients with cancer.

Exelixis, Inc. (Nasdaq: EXEL) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting. The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.

Exelixis, Inc. (Nasdaq: EXEL) today announced that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 5:15 p.m. PT / 8:15 p.m. PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in December:

Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. The sNDA is based on the final results of the phase 3 CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network, evaluating cabozantinib compared with placebo in advanced pNET and advanced epNET. In August 2024, Exelixis announced that the FDA granted orphan drug designation to cabozantinib for the treatment of pNET and assigned a Prescription Drug User Fee Act target action date of April 3, 2025.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in November:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the third quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its third quarter 2024 financial results will be released on Tuesday, October 29, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) vs. MSN Laboratories Private Limited et al. (MSN), Civil Action No. 22-00228 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt); 11,091,440 (pharmaceutical compositions); and 11,098,015 (methods of treatment). The District Court’s decision in Exelixis’ favor on the validity of these patents follows an earlier Stipulation entered on June 21, 2022, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’439, ’440, and ’015 patents, which expire on January 15, 2030.

Exelixis, Inc. (Nasdaq: EXEL) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma (HNSCC), and zanzalintinib with WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma (RCC).

Exelixis, Inc. (Nasdaq: EXEL) today announced updated and final data from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort with advanced pancreatic neuroendocrine tumors (pNET) and one cohort with advanced extra-pancreatic NET (epNET). These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: NETs and Endocrine Tumours at 2:45 p.m. CET and were simultaneously published in the New England Journal of Medicine (NEJM).

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: GU Tumours, Prostate at 2:45 p.m. CEST.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in September:

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Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted in the U.S. for: 1) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors (pNET), and 2) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated extra-pancreatic NET (epNET). The U.S. Food and Drug Administration (FDA) also granted orphan drug designation to cabozantinib for the treatment of pNET. The FDA assigned a standard review with a Prescription Drug User Fee Act target action date of April 3, 2025.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2024 financial results will be released on Tuesday, August 6, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in a fireside chat at the William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 4:20 p.m. ET / 3:20 p.m. CT / 1:20 p.m. PT in Chicago.

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla). This settlement resolves two patent litigations brought by Exelixis in response to Cipla’s Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents. The first case (Civil Action No. 23-287), filed on March 16, 2023, relates to Cipla’s ANDA for a 60 mg cabozantinib dosage strength. The second case (Civil Action No. 24-565-RGA), filed on May 9, 2024, relates to a recent amendment to Cipla’s ANDA, for the primary purpose of seeking additional approval for 20 mg and 40 mg cabozantinib dosage strengths.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in May:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the first quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its first quarter 2024 financial results will be released on Tuesday, April 30, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.