Exelixis Inc - EXEL STOCK NEWS

Exelixis (NASDAQ: EXEL) has initiated the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors. XB010 is an antibody-drug conjugate (ADC) targeting the tumor antigen 5T4, developed through Exelixis' biotherapeutics collaboration network. The trial will evaluate XB010 as a single agent and in combination with pembrolizumab. The study includes a dose-escalation stage followed by expansion cohorts to assess tolerability and activity in specific indications. XB010 was constructed using Catalent's SMARTag site-specific bioconjugation platform, with its 5T4-targeting mAb discovered in collaboration with Invenra.

Exelixis (Nasdaq: EXEL) announced its Q2 2024 financial results, reporting total revenues of $637.2 million, up from $469.8 million in Q2 2023. Net product revenues from the cabozantinib franchise reached $437.6 million, with a GAAP diluted EPS of $0.77 and non-GAAP diluted EPS of $0.84.

The FDA accepted a supplemental new drug application (sNDA) for cabozantinib in advanced neuroendocrine tumors (NET), targeting a review date of April 3, 2025. Exelixis also announced a $150 million milestone payment from Ipsen and completed a $450 million stock repurchase program. An additional $500 million stock repurchase program is planned through the end of 2025.

Operating expenses showed a decrease in R&D and SG&A, leading to a GAAP net income of $226.1 million compared to $81.2 million in Q2 2023. Exelixis also highlighted updated clinical developments including the completion of the phase 3 CONTACT-02 study in metastatic castration-resistant prostate cancer.

Exelixis (Nasdaq: EXEL) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for treating advanced neuroendocrine tumors (NET). The application covers two indications: previously treated pancreatic NET (pNET) and extra-pancreatic NET (epNET). The FDA granted orphan drug designation for pNET and set a target action date of April 3, 2025.

The sNDA is based on the phase 3 CABINET trial results, which showed statistically significant and clinically meaningful improvement in progression-free survival with cabozantinib versus placebo. The trial was stopped early due to compelling activity, allowing placebo patients to cross over to cabozantinib. Final results will be presented at the 2024 ESMO Congress in September.

Exelixis (Nasdaq: EXEL) has announced the release date for its second quarter 2024 financial results. The company will disclose its financial performance on Tuesday, August 6, 2024, after the markets close. Following the release, Exelixis management will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and provide a general business update.

Interested parties can access the event through the company's website. To join the conference call, registration is required via a provided link, which will furnish a dial-in number and unique PIN. The live webcast can be accessed through the Event Calendar page under the Investors & News section of www.exelixis.com. A replay of the webcast will be available on the company's website for one year.

Exelixis (Nasdaq: EXEL) announced its participation in the William Blair 44th Annual Growth Stock Conference. The company will present a fireside chat on June 4 at 4:20 p.m. ET in Chicago.

The event will be webcast live on the company’s website, www.exelixis.com, and a replay will be available for at least 30 days post-event.

Exelixis (Nasdaq: EXEL) announced a settlement with Cipla and Cipla USA, Inc. regarding two patent litigations over CABOMETYX® (cabozantinib) tablets. The disputes stemmed from Cipla's ANDA seeking approval to market generic versions of CABOMETYX before the expiration of Exelixis' patents. The first litigation, filed on March 16, 2023, concerned a 60 mg dosage, and the second, filed on May 9, 2024, involved 20 mg and 40 mg dosages. Under the settlement, Cipla will be licensed to market generic CABOMETYX in the US from January 1, 2031, conditional on FDA approval. All ongoing litigation will be terminated, subject to FTC and DOJ review. The agreement details remain confidential.

Exelixis, Inc. (Nasdaq: EXEL) will participate in fireside chats at investor conferences in May, including BofA Securities Health Care Conference, Citizens JMP Life Sciences Conference, and RBC Capital Markets Global Healthcare Conference. The presentations will be webcast on www.exelixis.com with replay options available for at least 30 days.

Exelixis, Inc. (Nasdaq: EXEL) reported Q1 2024 financial results of $425M in total revenues, $379M from Cabozantinib Franchise U.S. Net Product Revenues. Restructuring expenses of $32.8M were recorded. GAAP Diluted EPS was $0.12, Non-GAAP Diluted EPS was $0.17. Exelixis focused on advancing pivotal trials, pipeline development, and label expansion for cabozantinib. The company maintained financial guidance for 2024. Positive clinical trial results were highlighted, and strategic priorities for 2024 were outlined. Exelixis also announced share repurchase program updates and key board member appointments.