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Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis, Inc. (Nasdaq: EXEL) announces the retirement of Charles Cohen, Ph.D., from its Board of Directors, effective May 25, 2022. Dr. Cohen, a co-founder, has served on the Board since November 1995, significantly contributing to the company's evolution in oncology therapies. His leadership, particularly in the Compensation Committee, has been pivotal in Exelixis' growth, highlighted by over $1 billion in 2021 net revenue from cabozantinib. The company expresses gratitude for his service and confidence in the ongoing leadership to continue advancing innovative cancer treatments.
Exelixis, Inc. (Nasdaq: EXEL) announced a positive opinion from the European Medicines Agency’s CHMP regarding CABOMETYX for treating adults with radioactive iodine-refractory differentiated thyroid carcinoma. This recommendation is based on the pivotal COSMIC-311 trial, which showed improved progression-free survival. The final decision from the European Commission is awaited. The CHMP's endorsement follows the FDA's September 2021 approval of CABOMETYX in the U.S. for similar indications.
Exelixis, Inc. (Nasdaq: EXEL) announced results from the final analysis of the COSMIC-312 trial evaluating cabozantinib (CABOMETYX®) combined with atezolizumab versus sorafenib in patients with untreated advanced hepatocellular carcinoma (HCC). The analysis showed no improvement in overall survival (OS) for the combination versus sorafenib. Consequently, Exelixis will not submit a supplemental New Drug Application to the FDA. The trial enrolled 837 patients across 281 centers globally, and further results will be presented at a medical meeting.
Exelixis (Nasdaq: EXEL) has announced its participation in several upcoming investor conferences in March 2022. These include the Cowen 42nd Annual Healthcare Conference on March 9, the Barclays Global Healthcare Conference on March 15, and the Oppenheimer 32nd Annual Healthcare Conference, also on March 15. The events will include virtual presentations accessible via the company’s website. Exelixis focuses on developing new therapies for difficult-to-treat cancers and has four products on the market, including CABOMETYX and COMETRIQ.
Exelixis reported total revenues of $451.1 million in Q4 2021 and $1.43 billion for the full year, showcasing significant growth compared to $270.1 million and $987.5 million in 2020. The cabozantinib franchise achieved U.S. net product revenues exceeding $1 billion, with $302.7 million generated in Q4. GAAP diluted EPS was $0.29 for Q4 and $0.72 for the year. R&D expenses rose to $222.3 million in Q4, driven by increased collaboration costs. Cash reserves amounted to $1.9 billion. The company projects 2022 total revenues between $1.525 billion and $1.625 billion.
Bristol Myers Squibb (BMY) and Exelixis (EXEL) report updated results from the CheckMate -9ER trial at ASCO GU 2022, highlighting the superiority of the Opdivo (nivolumab) and Cabometyx (cabozantinib) combination over sunitinib for advanced renal cell carcinoma. With a median follow-up of 32.9 months, patients receiving the combination achieved a median overall survival of 37.7 months and a progression-free survival of 16.6 months. No new safety concerns were identified, and health-related quality of life was significantly improved in the combination group.
Exelixis, Inc. (Nasdaq: EXEL) plans to announce its fourth quarter and full year 2021 financial results on February 17, 2022, after market close. A conference call and webcast will follow at 5:00 p.m. ET to discuss the results and provide a business update. Investors can access the call via the company’s website or by phone. Exelixis is a biopharmaceutical company focused on oncology, aiming to develop new treatments for challenging cancers. The company is a member of the S&P MidCap 400 index.
Exelixis, Inc. (Nasdaq: EXEL) will participate in a virtual fireside chat at the Guggenheim Healthcare Talks Oncology Day on February 9, 2022, at 1:30 PM ET. The event can be accessed via the company's website. Investors should log on 15 minutes early for software requirements. Exelixis focuses on developing therapies for difficult-to-treat cancers, with four approved products including CABOMETYX and COMETRIQ. The company is committed to advancing its pipeline through strategic partnerships and internal development.
Exelixis, Inc. (NASDAQ: EXEL) announced encouraging results for cabozantinib in combination with immunotherapies for advanced colorectal cancer. Cohort 16 of the COSMIC-021 trial showed an objective response rate (ORR) of 10% and a disease control rate (DCR) of 71% among 31 patients. Median overall survival (OS) was 14 months. The CAMILLA trial cohort 2 reported an ORR of 27.6% with a DCR of 86.2%. The findings highlight cabozantinib's potential role in treating chemotherapy-refractory colorectal cancer. The data will be presented at ASCO GI on January 22, 2022.
Tenaya Therapeutics (NASDAQ:TNYA) has selected TN-401 as a candidate gene therapy for treating genetic Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC) caused by PKP2 gene mutations, which affect over 70,000 patients in the U.S. Additionally, the company plans to submit IND applications for TN-201 and TN-301 in the latter half of 2022. Tenaya has appointed Jennifer Drimmer as General Counsel, bringing over 17 years of experience. The company aims to advance several therapeutic candidates towards clinical trials while enhancing its operational capabilities.