Exelixis' NDA for Zanzalintinib Accepted by FDA for Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 02 2026
0mins
Should l Buy EXEL?
Source: Newsfilter
- FDA Review Progress: Exelixis announced that its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer has been accepted for review by the FDA, with a target action date of December 3, 2026, marking a significant advancement in cancer treatment.
- Clinical Trial Results: The phase 3 STELLAR-303 trial demonstrated that the combination of zanzalintinib and atezolizumab significantly improved median overall survival and reduced the risk of death, highlighting its potential in treating metastatic colorectal cancer.
- Market Demand Response: The introduction of zanzalintinib addresses the urgent need for effective therapies for previously treated metastatic colorectal cancer patients, potentially enhancing Exelixis' competitive position in the oncology market.
- Future Outlook: Exelixis plans to collaborate closely with the FDA to expedite the review process for zanzalintinib, which, if approved, could provide new hope for patients with metastatic colorectal cancer and further solidify the company's leadership in innovative drug development.
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Analyst Views on EXEL
Wall Street analysts forecast EXEL stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for EXEL is 44.09 USD with a low forecast of 30.00 USD and a high forecast of 52.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
16 Analyst Rating
7 Buy
8 Hold
1 Sell
Moderate Buy
Current: 43.900
Low
30.00
Averages
44.09
High
52.00
Current: 43.900
Low
30.00
Averages
44.09
High
52.00
About EXEL
Exelixis, Inc. is an oncology company. The Company has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. It is also advancing and evolving its product pipeline portfolio, including its lead investigational asset, zanzalintinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma, for previously treated hepatocellular carcinoma and for previously treated, radioactive iodine-refractory differentiated thyroid cancer, and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer. The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor approved the treatment of hypertension in Japan.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Exelixis' NDA for Zanzalintinib Accepted by FDA for Review
- FDA Review Progress: Exelixis announced that its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer has been accepted for review by the FDA, with a target action date of December 3, 2026, marking a significant advancement in cancer treatment.
- Clinical Trial Results: The phase 3 STELLAR-303 trial demonstrated that the combination of zanzalintinib and atezolizumab significantly improved median overall survival and reduced the risk of death, highlighting its potential in treating metastatic colorectal cancer.
- Market Demand Response: The introduction of zanzalintinib addresses the urgent need for effective therapies for previously treated metastatic colorectal cancer patients, potentially enhancing Exelixis' competitive position in the oncology market.
- Future Outlook: Exelixis plans to collaborate closely with the FDA to expedite the review process for zanzalintinib, which, if approved, could provide new hope for patients with metastatic colorectal cancer and further solidify the company's leadership in innovative drug development.
See More
Exelixis and Summit Therapeutics: Promising Drug Candidates Ahead
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib with an FDA application, expecting several phase 3 clinical trials in 2023; positive results could significantly boost stock prices and enhance its market position in oncology.
- Cabometyx Patent Cliff: With Cabometyx facing patent expiration by 2030, Exelixis is diversifying its product lineup through new drug development to ensure sustained growth and competitiveness in the market.
- Summit Drug Ivonescimab: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in trials and is undergoing 42 clinical studies; FDA approval could lead to a significant stock price increase by 2026.
- Massive Market Potential: Ivonescimab is projected to reach peak sales of $53 billion, and despite clinical and regulatory risks, its extensive range of indications showcases Summit's substantial potential in the biopharmaceutical sector.
See More
Exelixis and Summit Therapeutics: Future Prospects
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib's FDA application, expected to replace Cabometyx by 2030, which would significantly enhance the company's market position in oncology.
- Clinical Trial Plans: Exelixis plans to initiate several phase 3 clinical trials this year and release two late-stage data sets, with positive results potentially driving stock price increases and ensuring continued growth before Cabometyx's patent expiration.
- Summit Drug Potential: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in comparative studies, and if it secures FDA approval in the U.S., it could significantly boost the company's stock price and market share.
- Extensive Clinical Research: Summit is conducting 42 clinical studies for ivonescimab, with analysts estimating peak sales could reach $53 billion, showcasing its vast potential across various indications despite clinical and regulatory risks.
See More
Wall Street Analysts Adjust Ratings
- Acumen Price Target Raised: BTIG raised Acumen Pharmaceuticals' price target from $4 to $7, with analyst Thomas Shrader maintaining a Buy rating, indicating confidence in the company's growth potential despite a closing price of $2.08 on Monday.
- Exelixis Target Price Increase: HC Wainwright & Co. raised the price target for Exelixis from $49 to $52, with analyst Robert Burns maintaining a Buy rating, reflecting optimism about its market performance, closing at $43.61 on Monday.
- Baker Hughes Price Target Upgraded: BMO Capital increased Baker Hughes' price target from $55 to $65, with analyst Phillip Jungwirth maintaining an Outperform rating, suggesting a positive outlook on its future performance, closing at $56.29 on Monday.
- Brown & Brown Price Target Cut: B of A Securities lowered the price target for Brown & Brown from $94 to $90, with analyst Joshua Shanker maintaining a Neutral rating, indicating a cautious stance on the company's short-term performance, closing at $79.62 on Monday.
See More
10 Healthcare Stocks with A+ EPS Revision Ratings Attracting Investor Attention
- EPS Rating Upgrade: Ten healthcare stocks have received the highest A+ EPS revision rating from analysts, indicating increased confidence in their profitability outlook, which may attract more investor interest.
- List of Companies: Companies such as Cardinal Health (CAH) and HCA Healthcare (HCA) have achieved A+ ratings, showcasing strong earnings expectations that could drive their stock prices higher.
- Market Reaction: As analysts revise their earnings estimates upward for these companies, investors may reassess their portfolios, thereby increasing overall market attention on healthcare stocks.
- Industry Trends: With the earnings season underway, the robust performance of healthcare stocks and positive analyst revisions may signal a sector recovery, further attracting capital inflows into this area.
See More
Exelixis Reports Preliminary 2025 Revenue of $2.123 Billion, Shares Drop 4.6%
- Financial Performance Preview: Exelixis announced a preliminary US net product revenue of $2.123 billion for 2025, but the market reacted negatively, causing shares to drop 4.6% to $42.01 in pre-market trading, indicating investor caution regarding future performance.
- 2026 Outlook: The company projects net product revenue for 2026 to be between $2.325 billion and $2.425 billion, which, while optimistic, may not instill confidence in investors about achieving these targets, potentially impacting long-term growth expectations.
- Market Turbulence: Several stocks showed poor performance in pre-market trading, with Synchrony Financial down 9.5% to $78.61 and Stoke Therapeutics down 8.7% to $30.00, reflecting a generally bearish market sentiment possibly influenced by macroeconomic factors.
- Other Stock Movements: Capital One Financial and Bread Financial Holdings fell 8.4% and 8.3%, respectively, indicating that financial stocks are under pressure in the current market environment, prompting investors to closely monitor upcoming earnings reports for future trends.
See More
Exelixis' NDA for Zanzalintinib Accepted by FDA for Review
- FDA Review Progress: Exelixis announced that its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer has been accepted for review by the FDA, with a target action date of December 3, 2026, marking a significant advancement in cancer treatment.
- Clinical Trial Results: The phase 3 STELLAR-303 trial demonstrated that the combination of zanzalintinib and atezolizumab significantly improved median overall survival and reduced the risk of death, highlighting its potential in treating metastatic colorectal cancer.
- Market Demand Response: The introduction of zanzalintinib addresses the urgent need for effective therapies for previously treated metastatic colorectal cancer patients, potentially enhancing Exelixis' competitive position in the oncology market.
- Future Outlook: Exelixis plans to collaborate closely with the FDA to expedite the review process for zanzalintinib, which, if approved, could provide new hope for patients with metastatic colorectal cancer and further solidify the company's leadership in innovative drug development.
See More
Exelixis and Summit Therapeutics: Promising Drug Candidates Ahead
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib with an FDA application, expecting several phase 3 clinical trials in 2023; positive results could significantly boost stock prices and enhance its market position in oncology.
- Cabometyx Patent Cliff: With Cabometyx facing patent expiration by 2030, Exelixis is diversifying its product lineup through new drug development to ensure sustained growth and competitiveness in the market.
- Summit Drug Ivonescimab: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in trials and is undergoing 42 clinical studies; FDA approval could lead to a significant stock price increase by 2026.
- Massive Market Potential: Ivonescimab is projected to reach peak sales of $53 billion, and despite clinical and regulatory risks, its extensive range of indications showcases Summit's substantial potential in the biopharmaceutical sector.
See More
Exelixis and Summit Therapeutics: Future Prospects
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib's FDA application, expected to replace Cabometyx by 2030, which would significantly enhance the company's market position in oncology.
- Clinical Trial Plans: Exelixis plans to initiate several phase 3 clinical trials this year and release two late-stage data sets, with positive results potentially driving stock price increases and ensuring continued growth before Cabometyx's patent expiration.
- Summit Drug Potential: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in comparative studies, and if it secures FDA approval in the U.S., it could significantly boost the company's stock price and market share.
- Extensive Clinical Research: Summit is conducting 42 clinical studies for ivonescimab, with analysts estimating peak sales could reach $53 billion, showcasing its vast potential across various indications despite clinical and regulatory risks.
See More
Wall Street Analysts Adjust Ratings
- Acumen Price Target Raised: BTIG raised Acumen Pharmaceuticals' price target from $4 to $7, with analyst Thomas Shrader maintaining a Buy rating, indicating confidence in the company's growth potential despite a closing price of $2.08 on Monday.
- Exelixis Target Price Increase: HC Wainwright & Co. raised the price target for Exelixis from $49 to $52, with analyst Robert Burns maintaining a Buy rating, reflecting optimism about its market performance, closing at $43.61 on Monday.
- Baker Hughes Price Target Upgraded: BMO Capital increased Baker Hughes' price target from $55 to $65, with analyst Phillip Jungwirth maintaining an Outperform rating, suggesting a positive outlook on its future performance, closing at $56.29 on Monday.
- Brown & Brown Price Target Cut: B of A Securities lowered the price target for Brown & Brown from $94 to $90, with analyst Joshua Shanker maintaining a Neutral rating, indicating a cautious stance on the company's short-term performance, closing at $79.62 on Monday.
See More
10 Healthcare Stocks with A+ EPS Revision Ratings Attracting Investor Attention
- EPS Rating Upgrade: Ten healthcare stocks have received the highest A+ EPS revision rating from analysts, indicating increased confidence in their profitability outlook, which may attract more investor interest.
- List of Companies: Companies such as Cardinal Health (CAH) and HCA Healthcare (HCA) have achieved A+ ratings, showcasing strong earnings expectations that could drive their stock prices higher.
- Market Reaction: As analysts revise their earnings estimates upward for these companies, investors may reassess their portfolios, thereby increasing overall market attention on healthcare stocks.
- Industry Trends: With the earnings season underway, the robust performance of healthcare stocks and positive analyst revisions may signal a sector recovery, further attracting capital inflows into this area.
See More
Exelixis Reports Preliminary 2025 Revenue of $2.123 Billion, Shares Drop 4.6%
- Financial Performance Preview: Exelixis announced a preliminary US net product revenue of $2.123 billion for 2025, but the market reacted negatively, causing shares to drop 4.6% to $42.01 in pre-market trading, indicating investor caution regarding future performance.
- 2026 Outlook: The company projects net product revenue for 2026 to be between $2.325 billion and $2.425 billion, which, while optimistic, may not instill confidence in investors about achieving these targets, potentially impacting long-term growth expectations.
- Market Turbulence: Several stocks showed poor performance in pre-market trading, with Synchrony Financial down 9.5% to $78.61 and Stoke Therapeutics down 8.7% to $30.00, reflecting a generally bearish market sentiment possibly influenced by macroeconomic factors.
- Other Stock Movements: Capital One Financial and Bread Financial Holdings fell 8.4% and 8.3%, respectively, indicating that financial stocks are under pressure in the current market environment, prompting investors to closely monitor upcoming earnings reports for future trends.
See More
