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 ...

Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Exelixis (EXEL) and Incyte (INCY) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank puts an emphasis on earnings estimates and estimate revisions, while o ...

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 ...

Exelixis, Inc. (EXEL) announced that its supplemental new drug application (sNDA) for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025.The sNDA is seeking approval for the drug to treat adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET).Exelixis’ shares have surged 48.9% year to date against the industry’s decline of 7.8%.Image Source: Zacks Investment ResearchDetails of EXEL’s sNDA f ...

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 ...

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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 ...