FDA Update on Cabozantinib sNDA - The FDA notified Exelixis about an update to its supplemental new drug application (sNDA) for cabozantinib, seeking approval for treating adults with advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) [1] - The sNDA was initially scheduled for discussion at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025 but will no longer be discussed, with a target action date of April 3, 2025 [2] - The sNDA is based on the final results of the phase III CABINET pivotal trial, which evaluated cabozantinib versus placebo in advanced pNET and epNET [11] Clinical Trial Results and Orphan Drug Designation - The CABINET trial showed substantial improvement in progression-free survival (PFS), leading to the recommendation to stop enrollment and unblind patients to allow crossover from placebo to cabozantinib [3] - Final results confirmed statistically significant and clinically meaningful improvements in PFS with cabozantinib versus placebo [8] - The FDA granted cabozantinib orphan drug designation for the treatment of pNET in August 2024 [4] Cabometyx Sales and Pipeline Expansion - Exelixis generated $1.3 billion in product revenues in the first nine months of 2024, primarily from Cabometyx sales [9] - The company is working to expand the Cabometyx label and diversify its oncology portfolio beyond Cabometyx [9] - Another promising candidate, zanzalintinib, is being evaluated in late-stage studies for metastatic refractory colorectal cancer, with preliminary results expected in 2025 [13] Collaboration with Merck - Exelixis is collaborating with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma (HNSCC) and with Welireg for renal cell carcinoma (RCC) [5] - Merck will supply Keytruda for the phase III STELLAR-305 study in previously untreated PD-L1-positive recurrent or metastatic HNSCC [10] Stock Performance and Industry Comparison - Exelixis' shares have gained 53.2% in the past six months, outperforming the industry's decline of 10.1% [7] - The company currently carries a Zacks Rank 2 (Buy), while other top-ranked biotech stocks include Immunocore Holdings plc (IMCR) and Castle Biosciences, Inc. (CSTL), both with a Zacks Rank 1 (Strong Buy) [6]

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Shares of Exelixis, Inc. (EXEL) have surged 50% in a year against the industry’s decline of 16.1%. The stock has also outperformed the sector and the S&P 500 Index in this timeframe.The company's stellar performance can be attributed to the strong growth of its lead drug, Cabometyx, raised guidance and encouraging pipeline progress.EXEL Outperforms Industry, Sector & S&P 500Image Source: Zacks Investment ResearchCabometyx Boosts EXELCabometyx maintained its status as the leading tyrosine kinase inhibitor (T ...

Core Viewpoint - The comparison between Exelixis (EXEL) and Incyte (INCY) indicates that EXEL is currently more attractive to value investors due to its stronger earnings estimate revisions and more favorable valuation metrics [3][7]. Valuation Metrics - EXEL has a forward P/E ratio of 17.53, significantly lower than INCY's forward P/E of 53.46 [5]. - EXEL's PEG ratio stands at 0.74, while INCY's PEG ratio is 2, suggesting that EXEL is expected to grow at a more favorable rate relative to its price [5]. - The P/B ratio for EXEL is 4.24, which is comparable to INCY's P/B of 4.25, indicating similar market value versus book value [6]. Analyst Outlook - EXEL holds a Zacks Rank of 2 (Buy), reflecting a more positive analyst outlook compared to INCY's Zacks Rank of 3 (Hold) [3]. - The stronger estimate revision activity for EXEL suggests a more favorable future performance as perceived by analysts [7]. Value Grades - EXEL has a Value grade of B, while INCY has a Value grade of C, further supporting the conclusion that EXEL is the superior option for value investors at this time [7].

ROTTERDAM, The Netherlands, Dec. 17, 2024 /PRNewswire/ -- Sairopa B.V., today announced it has achieved a milestone event in its exclusive clinical development and option agreement with Exelixis, Inc. (Nasdaq: EXEL) involving ADU-1805, an innovative anti-SIRPα antibody with the potential to enhance the immune system's ability to combat cancer. Under the terms of the agreement, Exelixis has an exclusive option to license worldwide development and commercialization rights for ADU-1805 and other anti-SIRPα ant ...

A month has gone by since the last earnings report for Exelixis (EXEL) . Shares have added about 10.8% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Exelixis due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Exelixis Beats on Q3 Earnings and Sales, Raises Annual O ...

Core Viewpoint - Exelixis, Inc. is seeking approval for cabozantinib to treat advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic NET, with a discussion scheduled at an ODAC meeting in March 2025 [1][3]. Company Developments - Exelixis' shares have increased by 48.9% year to date, contrasting with a 7.8% decline in the industry [2]. - The FDA has notified Exelixis about the upcoming ODAC meeting, which will evaluate the safety and effectiveness of cabozantinib for the new indications [3]. - Cabozantinib, marketed as Cabometyx, is currently approved for advanced renal cell carcinoma and other cancers, including hepatocellular carcinoma and differentiated thyroid cancer [4][5]. Clinical Trial Insights - The sNDA for cabozantinib is based on the final results of the phase III CABINET trial, which showed significant improvements in progression-free survival compared to placebo [6][8]. - The trial was halted early due to substantial benefits observed, leading to a recommendation for crossover from placebo to cabozantinib [7]. Future Prospects - Exelixis plans to submit an additional sNDA for cabozantinib in combination with Tecentriq for metastatic castration-resistant prostate cancer later this year [9]. - The company generated $1.3 billion in product revenues in the first nine months of 2024, primarily from Cabometyx sales [9]. - The potential label expansion is expected to further boost sales and diversify Exelixis' oncology portfolio [10]. Pipeline Developments - Zanzalintinib, a next-generation oral TKI, is being evaluated in the late-stage STELLAR-303 study for metastatic colorectal cancer, with preliminary results expected in 2025 [11]. - Exelixis has partnered with Merck to study zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma [12][13].

Shares of Exelixis, Inc. (EXEL) have surged 25% in a month against the industry’s decline of 4.9%. The stock has also outperformed the sector and the S&P 500 Index in this timeframe.The outperformance can be attributed to better-than-expected third-quarter results. The company also raised its annual guidance.Exelixis has been a consistent outperformer of late on the back of the strong performance of its lead drug Cabometyx and encouraging pipeline progress.EXEL Outperforms Industry, Sector & S&P 500Image So ...

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market engagement and confidence [1] - The Zacks Style Scores serve as a complementary indicator to the Zacks Rank, helping investors select stocks with high potential for market outperformance [3][9] Zacks Style Scores - The Style Scores categorize stocks into four types: Value Score, Growth Score, Momentum Score, and VGM Score, each focusing on different investment strategies [5][6][7][8] - Each stock is rated from A to F based on its characteristics, with A indicating the highest potential for outperformance [4] Value Score - The Value Style Score identifies stocks that are undervalued based on financial ratios such as P/E, PEG, and Price/Sales [5] Growth Score - The Growth Style Score assesses a company's financial health and future growth potential through metrics like earnings and sales projections [6] Momentum Score - The Momentum Style Score focuses on stocks with favorable price trends, utilizing factors like recent price changes and earnings estimate revisions [7] VGM Score - The VGM Score combines the three Style Scores to provide a comprehensive rating, highlighting stocks with attractive value, growth, and momentum [8] Zacks Rank - The Zacks Rank is a proprietary model that uses earnings estimate revisions to guide investors in stock selection, with 1 (Strong Buy) stocks historically yielding an average annual return of +25.41% since 1988 [10] - A significant number of stocks are rated under the Zacks Rank, with over 800 top-rated options available [11] Stock to Watch: Exelixis (EXEL) - Exelixis, Inc. is an oncology-focused biotechnology company engaged in developing treatments for challenging cancers [15] - EXEL holds a 2 (Buy) rating on the Zacks Rank and has a VGM Score of A, with a Value Style Score of B, supported by a forward P/E ratio of 18.46 [16] - Recent upward revisions in earnings estimates indicate a positive outlook, with the Zacks Consensus Estimate rising to $1.93 per share [16] - With strong ratings and scores, EXEL is positioned as a notable investment opportunity [17]

Growth investors focus on stocks that are seeing above-average financial growth, as this feature helps these securities garner the market's attention and deliver solid returns. However, it isn't easy to find a great growth stock.That's because, these stocks usually carry above-average risk and volatility. In fact, betting on a stock for which the growth story is actually over or nearing its end could lead to significant loss.However, it's pretty easy to find cutting-edge growth stocks with the help of the Z ...