Core Insights - Exelixis' lead drug, Cabometyx, has received FDA approval for label expansion to treat adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (NET) in March 2025, marking a significant advancement for the company [1][10] Product Overview - Cabometyx is the first and only systemic treatment FDA approved for previously treated NET, applicable regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The drug is noted as the first broadly applicable new oral small molecule therapy for NET in nine years [2] Market Demand and Performance - Initial uptake for Cabometyx's new indication is strong, capturing 35% of the new patient share for oral therapies in this indication, with demand just over 4% of total demand for cabozantinib in Q2 [3][10] - Exelixis expects Cabometyx to be widely used across various patient and tumor characteristics, including those with NET from the pancreas, GI tract, and lung [5] Regulatory Approvals - In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic well-differentiated extra-pancreatic and pancreatic NET in the EU [4] Competitive Landscape - Cabometyx faces competition from Novartis' Lutathera, which is also used for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [6] - In the renal cell carcinoma (RCC) space, Cabometyx competes with Merck's Keytruda and Inlyta, as well as Merck's Welireg [7][8] Financial Performance - Exelixis shares have gained 13.8% year-to-date, outperforming the industry growth of 4% [9][10] - The company's valuation is considered high, with a price/sales ratio of 4.07x forward sales, above its mean of 3.64x and the biotech industry's 1.58x [11] Earnings Estimates - The bottom-line estimate for 2025 has increased from $2.65 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.08 over the past 30 days [12]

Group 1 - The article discusses Stephen's background as a Registered Nurse (RN) and an MBA, highlighting his unique approach to analyzing healthcare and tech stocks through the "Dizzy Framework" [1] - The "Dizzy Framework" is designed to mitigate common behavioral errors in investment, such as chasing market noise and adhering too rigidly to prior beliefs, emphasizing the importance of quality and timing of information [1] - Influences on Stephen's investment philosophy include concepts from "Superforecasting" and "Fooled by Randomness," which inform his disciplined and patient investment approach [1]

Core Insights - Exelixis (EXEL) has been actively repurchasing shares to enhance shareholder value, with a total authorization of $1 billion for buybacks through 2025 [1][6] - The company has successfully reduced its outstanding shares from 326.3 million to 284.4 million as of June 30, 2025, following its share repurchase initiatives [2][6] - EXEL's stock has outperformed the biotech industry, gaining 13.4% year-to-date compared to the industry's 3.6% growth [5] Share Repurchase Programs - In August 2024, EXEL's board authorized a stock repurchase program to buy back up to $500 million of common stock before December 31, 2025 [1] - An additional $500 million repurchase was authorized in February 2025, bringing the total repurchase authorization to $1 billion [2] - As of June 30, 2025, EXEL had repurchased $796.3 million of its common stock at an average price of $36.69 per share [2][6] Financial Position - At the end of Q2 2025, EXEL reported cash and cash equivalents and marketable securities totaling $791 million, indicating a strong cash position to meet its repurchase targets [3] - The company’s average buyback price of $36.69 per share has contributed to a significant reduction in shares outstanding [6] Industry Context - Other major pharmaceutical and biotech companies, such as Regeneron and Novartis, are also engaging in share buybacks to enhance shareholder value [3][4] - Regeneron repurchased shares worth $1.070 billion, while Novartis repurchased 48.8 million shares for $5.3 billion in the first half of 2025 [4] Valuation Metrics - EXEL's shares are currently trading at a price/sales ratio of 4.07x forward sales, which is higher than its historical mean of 3.64x and the biotech industry's average of 1.58x, indicating a potentially expensive valuation [8] - The bottom-line estimate for 2025 has increased from $2.64 to $2.68, while the estimate for 2026 has slightly decreased from $3.13 to $3.09 [9]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Exelixis, Inc. and its officers or directors [1] Financial Performance - On July 28, 2025, Exelixis reported second-quarter financial results, revealing net product revenues for cabozantinib were approximately 2% below the consensus estimate of $531.3 million [3] - Following the announcement, Exelixis's stock price dropped by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [3] Clinical Development Update - Exelixis decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck due to emerging competition and assessment of other commercial opportunities [3]

Core Insights - Exelixis (EXEL) has shown strong year-to-date performance with a 15.6% increase in share price, significantly outperforming the industry growth of 2.9% [1] - Despite reaching a 52-week high of $49.62 on June 23, 2025, shares dipped following mixed quarterly results reported on July 28 [1][4] - The company’s lead drug, Cabometyx, continues to perform well in the renal cell carcinoma (RCC) market, supported by strong demand and recent label expansions [5][6] Company Performance - Exelixis' stock has outperformed both the sector and the S&P 500 Index during the year [1] - The company reported a revenue miss in the second quarter, which has affected investor sentiment [8][20] - Cabometyx remains the leading tyrosine kinase inhibitor (TKI) for RCC, with strong sales driven by its combination with Bristol Myers' Opdivo [5][6] Drug Pipeline and Developments - Zanzalintinib, an investigational TKI, has shown positive results in the STELLAR-303 study, meeting a key endpoint for overall survival in metastatic colorectal cancer [10][12] - The company has decided not to proceed with the phase III portion of the STELLAR-305 trial for zanzalintinib due to emerging competition and a focus on larger commercial opportunities [14] - Exelixis is actively expanding its pipeline with three ongoing phase I studies and has received FDA clearance for a new IND application [15] Financial Outlook - Exelixis shares are currently trading at a price/sales ratio of 4.14x forward sales, higher than the biotech industry average of 1.59x [16] - The bottom-line estimate for 2025 has increased slightly from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 [17] Competitive Landscape - Cabometyx faces significant competition in the RCC market, particularly from Merck's Keytruda and Pfizer's Inlyta [20][21] - Keytruda is a leading drug in the RCC space, accounting for approximately 50% of Merck's pharmaceutical sales [21]

Core Insights - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI) targeting receptor tyrosine kinases involved in cancer growth, with recent studies showing positive data [1] Study Results - In June 2025, Exelixis announced positive top-line results from the STELLAR-303 study, a phase III trial involving 901 patients with metastatic colorectal cancer, comparing zanzalintinib plus Tecentriq against regorafenib [2] - The STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival (OS) for the intent-to-treat population treated with zanzalintinib plus Tecentriq compared to regorafenib [3] - Enrollment for the STELLAR-304 study was completed in May 2025, evaluating zanzalintinib in combination with Opdivo versus sunitinib in advanced non-clear cell renal cell carcinoma [4] - Exelixis has opted not to proceed with the phase III portion of the STELLAR-305 trial based on emerging data and competition in advanced squamous cell carcinoma [5] - The company initiated the phase III STELLAR-311 study in advanced neuroendocrine tumors, comparing zanzalintinib to everolimus [6] Competitive Landscape - The competitive environment for renal cell carcinoma (RCC) is intensifying, with significant competition for Exelixis's lead drug, Cabometyx, from various immunotherapy-TKI combinations [7] - Keytruda, approved for advanced RCC, accounts for approximately 50% of Merck's pharmaceutical sales, highlighting the competitive pressure in the market [10] Financial Performance - Exelixis shares have increased by 14% year-to-date, contrasting with a 0.9% decline in the biotech industry [11] - The company's shares are currently trading at a price/sales ratio of 4.09x forward sales, above its historical mean of 3.64x and the biotech industry's average of 1.59x [13] - The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 over the past 30 days [14]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Exelixis, Inc. and its officers or directors [1] Financial Performance - Exelixis reported net product revenues for cabozantinib at approximately $520.9 million, which is about 2% below the consensus estimate of $531.3 million [3] - Following the announcement of financial results, Exelixis's stock price dropped by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [3] Clinical Development - Exelixis decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck due to emerging competition and assessment of other commercial opportunities [3]

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Exelixis, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers [1] - Exelixis reported second-quarter financial results on July 28, 2025, revealing net product revenues for cabozantinib were approximately 2% below the consensus estimate of $531.3 million [2] - The company decided not to proceed to the phase 3 portion of the STELLAR-305 study in advanced squamous cell carcinoma due to emerging competition and assessment of other commercial opportunities [2] - Following the announcement, Exelixis's stock price fell by $7.45 per share, or 16.78%, closing at $36.94 per share on July 29, 2025 [2] Company Overview - Exelixis, Inc. is involved in the development and commercialization of innovative therapies for cancer treatment [2] - The company has faced scrutiny regarding its business practices and financial disclosures, leading to an investigation by Pomerantz LLP [1][2] Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3] - The firm has successfully recovered multimillion-dollar damages on behalf of class members in the past [3]

Group 1 - Exelixis is actively marketing cabozantinib (Cabometyx, Cometriq) for its current indications while also developing zanzalintinib, which has seen both successes and disappointments [1] - A buy rating was assigned to Exelixis in February, indicating a positive outlook on the company's stock performance [1] Group 2 - The article reflects the author's personal opinions on biotech stocks, focusing on trading around significant events such as trial results and NDA/BLA approvals [1]

Group 1: Celestica (CLS) - Celestica exceeded Q2 earnings expectations, with sales of $2.89 billion, a 21% increase from $2.39 billion a year ago, surpassing estimates by 8% [3] - Q2 earnings soared 53% year-over-year to $1.39 per share, exceeding expectations of $1.24 by 12% [3] - The stock hit an all-time high of $208, spiking 16% in a single trading session, driven by high demand for communications and enterprise hardware products [2][4] - Celestica's stock has increased over 115% in 2025 and more than 135% in the last three months, outperforming broader market indexes [4] Group 2: Exelixis (EXEL) - Exelixis reported Q2 EPS of $0.75, beating expectations of $0.65 by 15%, despite a decline from $0.84 in the previous year [5] - Sales were $568.26 million, missing estimates of $578.91 million and down from $637.18 million in Q2 2024 [5][6] - The stock fell nearly 17% post-earnings, presenting a potential buy-the-dip opportunity, despite reaffirming full-year revenue guidance of $2.25-$2.35 billion [5][7] - Exelixis' stock is down 5% in 2025 but has increased over 80% in the last two years, currently trading under $40 with a forward earnings multiple of 16.6 [9]