Exelixis Inc - EXEL STOCK NEWS

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.

Exelixis (Nasdaq: EXEL) has announced the release date for its third quarter 2024 financial results. The results will be disclosed on Tuesday, October 29, 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 via the Internet from the company's website. To join the conference call, registration is required through a provided link, which will supply 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 archived on the company's website for one year.

Exelixis, Inc. (Nasdaq: EXEL) announced a favorable ruling in its patent litigation against MSN Laboratories. The U.S. District Court for the District of Delaware upheld the validity of three Orange Book-listed patents related to cabozantinib, rejecting MSN's challenge. These patents expire on January 15, 2030. The court also ruled that Exelixis' pharmaceutical composition patent is not invalid and not infringed by MSN's proposed ANDA product.

Previously, MSN had stipulated that its proposed generic cabozantinib product would infringe the patents in question. As a result of this ruling, the earliest MSN may launch its generic product in the U.S. is January 15, 2030, subject to appeals and regulatory exclusivity. Exelixis expressed confidence in its cabozantinib patent estate and commitment to defending its intellectual property rights.

Exelixis (EXEL) and Merck (MRK) have announced a clinical development collaboration to evaluate combinations of Exelixis' investigational tyrosine kinase inhibitor zanzalintinib with Merck's therapies in head and neck cancer and renal cell carcinoma (RCC). The collaboration includes:

1. A phase 3 trial combining zanzalintinib with KEYTRUDA (pembrolizumab) for head and neck squamous cell carcinoma (HNSCC).

2. A phase 1/2 trial and two phase 3 trials combining zanzalintinib with WELIREG (belzutifan) for RCC.

Merck will supply KEYTRUDA for the ongoing STELLAR-305 trial in HNSCC and sponsor the RCC trials. Exelixis will co-fund some studies and supply zanzalintinib and cabozantinib. Exelixis retains global commercial rights to zanzalintinib.

Exelixis (EXEL) announced final results from the phase 3 CABINET study evaluating cabozantinib in advanced neuroendocrine tumors (NET). The study showed significant improvement in progression-free survival (PFS) versus placebo in both pancreatic NET (pNET) and extra-pancreatic NET (epNET) cohorts:

- pNET cohort: median PFS of 13.8 months for cabozantinib vs 4.4 months for placebo (HR 0.23, p<0.0001)
- epNET cohort: median PFS of 8.4 months vs 3.9 months (HR 0.38, p<0.0001)

The data supported Exelixis' supplemental New Drug Application to the FDA for cabozantinib in advanced NET, with a target action date of April 3, 2025. The safety profile was consistent with known data, and no new signals were identified.

Exelixis (EXEL) presented final overall survival (OS) results from the CONTACT-02 phase 3 study evaluating cabozantinib (CABOMETYX®) with atezolizumab in metastatic castration-resistant prostate cancer (mCRPC) at ESMO 2024. The study showed a numerical but not statistically significant improvement in OS favoring the combination (HR: 0.89; P=0.296). Notably, improved OS was observed in patients with bone or liver metastases. The combination demonstrated a manageable safety profile with treatment-related grade 3-4 adverse events occurring in 40% of patients. Exelixis plans to submit a supplemental New Drug Application for this combination in mCRPC later this year, based on the previously reported statistically significant progression-free survival benefit.

Exelixis (Nasdaq: EXEL) has announced its participation in three major investor conferences this September. The company will present at:

• Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 9:15 a.m. ET in New York City
• 2024 Wells Fargo Healthcare Conference on September 6 at 10:15 a.m. ET in Everett, MA
• Bank of America Global Healthcare Conference 2024 on September 18 at 10:50 a.m. BST in London, UK

All presentations will be webcast live on www.exelixis.com under the Investors & News section. Replays will be available for at least 30 days after each event.

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.