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Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium
Businesswire· 2025-10-12 22:10
Core Insights - Natera, Inc. is showcasing its technology at the European Society for Medical Oncology (ESMO) Congress, with 14 studies presented, including six oral presentations that emphasize its leadership in molecular residual disease (MRD) testing across various cancer types [1][2]. Bladder Cancer Highlights - The IMvigor011 trial, sponsored by Genentech, will present data on Signatera's predictive capabilities for disease-free survival (DFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) [2]. - The CheckMate 274 trial results indicate that DFS for Signatera-positive patients treated with nivolumab was 7.4 months compared to 2.8 months for placebo, with a hazard ratio of 0.35, highlighting the effectiveness of MRD-guided treatment [3]. Additional ESMO Data - Other oral presentations will cover results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera's early cancer detection program, showcasing the breadth of research utilizing Signatera [4]. Expert Commentary - Experts emphasize that Signatera MRD can identify bladder cancer patients likely to benefit from adjuvant immunotherapy, aiming to improve treatment outcomes and change medical practices [5]. Presentation Schedule - A detailed schedule of presentations featuring Natera's technology at ESMO includes various studies on bladder cancer, colorectal cancer, and breast cancer, with specific dates and presenters listed [6][7][8][9][10][11].
REPL Stock Plunges 54% in 3 Months After FDA Rejects Skin Cancer Drug
ZACKS· 2025-09-24 16:11
Core Insights - Replimune Group's share price has decreased by 54.2% over the past three months following the FDA's complete response letter (CRL) regarding its biologics license application (BLA) for RP1 in combination with Opdivo for advanced melanoma treatment [1][5] - The FDA's CRL was based on the inadequacy of data from the IGNYTE study, which did not meet the standards for a well-controlled clinical investigation, although no safety concerns were raised [2][5] - The setback has created significant uncertainty regarding the regulatory path for RP1, delaying Replimune's prospects of launching its first approved product and establishing a revenue stream [3][4] Company Developments - Replimune has completed a Type A meeting with the FDA to discuss the CRL and is currently reviewing the agency's feedback to determine next steps, although a clear regulatory path remains uncertain [6][7] - The BLA for RP1 in combination with Opdivo was initially accepted for review under the FDA's Priority Review pathway in January 2025, based on the IGNYTE study's primary analysis data [8] - Replimune is also exploring RP1 for other indications, including non-melanoma skin cancers and as a monotherapy for solid organ transplant recipients with skin cancers [11] Market Context - Year-to-date, Replimune's shares have fallen by 64.2%, contrasting with a 3.6% growth in the broader industry [4] - The company is facing challenges in delivering on its lead program, which has raised broader investor concerns about its future performance [3]
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]
CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
ZACKS· 2025-04-01 20:00
Core Viewpoint - Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the approval of Opdivo (nivolumab) for additional indications in treating non-small cell lung cancer (NSCLC) and for a subcutaneous formulation across multiple solid tumor indications [1][10]. Group 1: Opdivo Approval and Clinical Trials - The CHMP recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy after surgical resection for high-risk resectable NSCLC patients with PD-L1 expression ≥1% [2]. - The positive CHMP opinion was based on the CheckMate-77T trial, which showed significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo [3]. - The CheckMate-77T study also demonstrated improvements in secondary efficacy endpoints, including pathologic complete response and major pathologic response (MPR) [4]. Group 2: Market Performance and Growth - BMY's shares have increased by 21.4% over the past year, contrasting with a 7.1% decline in the industry [9]. - The approval of Opdivo Qvantig for subcutaneous use is expected to enhance the immuno-oncology franchise's impact into the next decade [12]. - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition [13]. Group 3: Recent Acquisitions and New Approvals - BMY recently acquired 2seventy bio, Inc. for $286 million, with plans to close the acquisition in the second quarter of 2025 [15]. - The approval of Cobenfy for schizophrenia represents a new pharmacological approach, with initial sales of $10 million in 2024 expected to contribute significantly to BMY's revenue [14].