Opdivo (nivolumab)

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EXEL Q2 Earnings Top, Sales Miss on Lower Collaboration Revenues
ZACKS· 2025-07-29 14:42
Core Viewpoint - Exelixis, Inc. reported mixed results for Q2 2025, with adjusted earnings beating estimates but revenues missing expectations, leading to a decline in stock price in pre-market trading [2][3][25] Financial Performance - Adjusted earnings were 75 cents per share, exceeding the Zacks Consensus Estimate of 65 cents, but down from 84 cents in the same quarter last year [2][8] - Net revenues totaled $568.3 million, missing the Zacks Consensus Estimate of $579 million and reflecting a 10.8% year-over-year decline [3][8] - Net product revenues were $520 million, marking an 18.8% increase year-over-year, primarily driven by increased sales volume [5][8] Product Performance - Cabometyx generated revenues of $517.9 million, falling short of the Zacks Consensus Estimate of $527 million but surpassing the model estimate of $511.3 million [6][8] - The demand for Cabometyx's new indication for neuroendocrine tumors accounted for just over 4% of total demand in Q2, with expectations for growth [9][25] Collaboration and Revenue Sources - Collaboration revenues plummeted 70% to $48.2 million from $199.6 million in the prior year, largely due to a significant milestone payment recognized in the previous quarter [10][25] Expenses - Research and development expenses were $200.3 million, down 5.1% year-over-year, while selling, general, and administrative expenses rose 2.1% to $134.9 million [11][25] Stock Repurchase Program - Exelixis has repurchased $796.3 million of its common stock at an average price of $36.69 per share, with $204 million remaining under the current repurchase plan [12][13] Guidance - The company maintains its 2025 revenue guidance of $2.25 billion to $2.35 billion, with net product revenues expected between $2.05 billion and $2.15 billion [14][15] Pipeline Developments - Exelixis is advancing its pipeline with zanzalintinib, which has shown promising results in the STELLAR-303 study for metastatic colorectal cancer [16][18] - The company has three ongoing phase I studies and plans to initiate a phase I study for XB371 soon [23] Legal Settlement - In July 2025, Exelixis settled patent litigation with Biocon Pharma, allowing Biocon to market a generic version of Cabometyx in the U.S. starting January 1, 2031, if approved [24]
Why Is Nano-Cap MiNK Therapeutics Stock Gaining Over 400% On Friday?
Benzinga· 2025-07-11 16:33
Core Insights - MiNK Therapeutics, Inc. is experiencing a significant increase in stock price, with INKT stock rising 471.3% to $44.16 [7] - The company is focused on developing allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, with promising clinical results reported [2] Clinical Developments - A landmark case published in Nature's Oncogene reported a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer after receiving a single infusion of agenT-797 combined with Bristol-Myers Squibb's Opdivo [2][3] - The patient showed no evidence of disease over two years, with donor iNKT cells detectable for up to six months post-infusion, and the treatment was well-tolerated without severe side effects [4] - Data from a Phase 2 trial in 2L gastric cancer presented at the 2025 AACR Immuno-Oncology meeting indicated immune activation and early signs of tumor control in patients previously resistant to checkpoint inhibitors, with some patients surviving beyond 12 months [5] - A separate peer-reviewed case report noted a patient with metastatic gastric cancer achieving a 42% tumor reduction and over nine months of progression-free survival following a single infusion of agenT-797 combined with nivolumab [6] Market Activity - The trading volume for INKT stock reached 20.2 million, significantly higher than the average volume of 7.5 million [1]
BMY's Opdivo SC Gets EU Nod for Multiple Solid Tumor Indications
ZACKS· 2025-05-29 16:46
Core Insights - The European Commission has approved the subcutaneous formulation of Opdivo (nivolumab) for multiple solid tumor indications, making it the first PD-1 inhibitor approved for subcutaneous use in the EU [1][3]. Approval Details - The approval applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [1]. - Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase and is indicated for various adult solid tumors, either as monotherapy or in combination with other therapies [2][4]. Clinical Study Findings - The approval was supported by data from the CheckMate -67T clinical study, which demonstrated that the subcutaneous formulation has a pharmacokinetics and safety profile comparable to the intravenous version [4]. - The study showed that the subcutaneous formulation met primary pharmacokinetic noninferiority endpoints, with a geometric mean ratio for Cavgd28 of 2.10 and for Cminss of 1.77 [7]. - The objective response rate was 24% in the subcutaneous group compared to 18% in the intravenous group, indicating comparable efficacy [7]. Market Performance - Bristol Myers' shares have declined by 17% year to date, while the industry has seen a decline of 5.4% [3].
Is it a Good Idea to Invest in Immunocore Stock Right Now?
ZACKS· 2025-05-23 14:31
Core Insights - Immunocore's Kimmtrak is experiencing significant sales growth, generating $310 million in 2024, a nearly 30% increase year-over-year, with Q1 2025 sales rising 33.6% to $93.9 million [2][5][8] Company Performance - Immunocore's stock has increased by 5.8% year-to-date, contrasting with a 5.5% decline in the industry [3] - The company has a Zacks Rank 1 (Strong Buy), with narrowed loss per share estimates for 2025 from $1.50 to $0.86 and for 2026 from $1.68 to $1.34 [9] Product Development - Kimmtrak is approved in 39 countries and launched in 26, serving as the standard of care for metastatic uveal melanoma in most markets [1][5] - Ongoing label expansion studies for Kimmtrak aim to target earlier-line settings for melanoma indications [5] - Immunocore is developing brenetafusp in combination with Bristol Myers' Opdivo for first-line advanced cutaneous melanoma, with additional studies across various tumor types [6] Market Context - Bristol Myers' Opdivo recorded $2.26 billion in sales in Q1 2025, highlighting its significance as a growth driver in oncology [7]