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Nuvation Bio to Report Fourth Quarter and Full Year 2025 Financial Results and Provide Business Update on March 2, 2026
Prnewswire· 2026-02-17 21:05
Core Viewpoint - Nuvation Bio Inc. will report its financial results for Q4 and the full year of 2025 on March 2, 2026, and will provide a business update during a conference call [1]. Company Overview - Nuvation Bio is a global oncology company focused on addressing significant challenges in cancer treatment, aiming to develop therapies that positively impact patients' lives [1]. - The company's diverse pipeline includes: - Taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor - Safusidenib, a brain-penetrant IDH1 inhibitor - NUV-868, a BD2-selective BET inhibitor - An innovative drug-drug conjugate (DDC) program [1]. Event Details - The conference call and webcast will take place on March 2, 2026, at 4:30 p.m. ET, and both investors and the public are invited to participate [1]. - Participants can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 833155 [1]. - An archived recording of the event will be available on Nuvation Bio's website for 90 days following the event [1].
Biotech Exit: $26 Million Arcellx Sale Follows Tepid Stock Performance and Kelonia Competition
Yahoo Finance· 2026-02-17 18:07
Core Insights - First Turn Management sold its entire stake of 313,733 shares in Arcellx for approximately $25.76 million, as disclosed in an SEC filing on February 13, 2026 [1][2] Company Overview - Arcellx is a clinical-stage biotechnology company focused on developing novel cell-based immunotherapies for cancer treatment, with a diversified pipeline targeting hematologic malignancies and solid tumors [5] - The company has a market capitalization of $3.96 billion, with a revenue of $35.90 million and a net income of -$217.90 million for the trailing twelve months (TTM) [4] Financial Performance - As of February 13, 2026, Arcellx shares were priced at $68.50, reflecting a 7.5% increase over the past year, although this performance lagged behind the S&P 500 by 4.3 percentage points [7] - The company's stock faced pressure due to competitive concerns, particularly related to CAR-T data from Kelonia Therapeutics [9] Investment Implications - The sale of Arcellx shares by First Turn Management suggests a consolidation of conviction in its portfolio, as the fund holds larger positions in other biotech companies [6] - The performance of Arcellx shares, while not catastrophic, indicates a lack of relative strength necessary for a concentrated, high-risk biotech strategy [7]
Genmab(GMAB) - 2025 Q4 - Earnings Call Transcript
2026-02-17 18:00
Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [24][25] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [25][27] - Sales of proprietary medicines totaled $632 million, up 54% year over year, accounting for approximately 28% of total revenue growth [14][24] Business Line Data and Key Metrics Changes - Epkinly achieved $468 million in sales for the year, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [15][24] - Tivdak generated $164 million in sales, representing a 26% year-over-year increase, maintaining market leadership in recurrent or metastatic cervical cancer [19][20] Market Data and Key Metrics Changes - Epkinly closed 2025 with regulatory approvals in more than 65 countries, nearly all featuring the dual indication [15] - The U.S. market saw increased uptake for Epkinly, particularly following its approval in second-line follicular lymphoma [17][18] - Tivdak's launch in Germany showed strong uptake, with positive physician feedback [20] Company Strategy and Development Direction - The company aims to accelerate the development of its late-stage pipeline and maximize the potential of its commercialized medicines [5][24] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, contributing to sustainable growth [6][25] - The focus for 2026 includes advancing proprietary portfolio impact, expanding market footprint, and preparing for multiple product launches [22][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 [29] - The company anticipates continued revenue growth driven by Epkinly and its royalty portfolio, with a guidance of 14% total revenue growth for 2026 [26][28] - Management highlighted the importance of maintaining substantial profitability while investing in growth opportunities [27][28] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, indicating multi-billion dollar potential [7] - The anticipated data readouts in 2026 are expected to set the stage for multiple important product launches and line extensions in 2027 [8][10] Q&A Session Summary Question: Next steps for Epkinly following EPCORE DLBCL-1 study results - Management confirmed that the study showed positive progression-free survival but missed overall survival, with ongoing discussions with regulatory agencies about the data [31][33] Question: Update on outpatient data for Epkinly - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [40][42] Question: Expectations for Rina-S pivotal phase two readout - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [47][49] Question: Expectations for EPCORE DLBCL-4 trial outcomes - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [53][55] Question: Thoughts on pembro approval in PROC and implications for Rina-S - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [57][59] Question: Clarification on phase 3 for petosemtamab - Management confirmed that the phase 3 studies have dual endpoints of overall response rate and overall survival, which are standard in areas of unmet medical need [75]
Aprea Therapeutics to Present at Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-17 13:00
Core Viewpoint - Aprea Therapeutics, Inc. is set to provide a corporate update at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, highlighting its innovative cancer therapies that target cancer-specific vulnerabilities while minimizing harm to healthy cells [1]. Group 1: Company Overview - Aprea is a clinical-stage biopharmaceutical company focused on developing therapies that exploit cancer cell mutations to treat various cancer types, including ovarian, endometrial, colorectal, and head and neck squamous cell carcinoma [3]. - The company's lead programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both currently in clinical development for solid tumor indications [4]. Group 2: Presentation Details - The corporate update will be presented virtually on February 26, 2026, at 8:40 am EST, with a webcast available for 90 days [2]. - Investors interested in one-on-one meetings with Aprea management during the conference can contact their Oppenheimer representative [2].
Syndax Pharmaceuticals Highlights Revuforj, Niktimvo Sales Surge and 2026 Milestones at Guggenheim Conf
Yahoo Finance· 2026-02-15 13:05
Core Insights - Syndax Pharmaceuticals is experiencing significant growth driven by its products Revuforj and Niktimvo, with a strong commercial performance expected to continue into 2026 [4][7]. Product Performance - Revuforj has shown a 38% growth in the fourth quarter, attributed to its use in KMT2A-rearranged acute myeloid leukemia (AML) and new momentum in NPM1-mutant AML following recent guideline inclusion and approval [2][3]. - Niktimvo has generated $152 million in net sales within its first 11 months on the market for chronic graft-versus-host disease (GVHD), indicating strong uptake [3][7]. - The company anticipates Revuforj's average treatment duration to increase from 4-6 months to 6-12 months as maintenance adoption rises from 35-40% to an expected 70-80% [6][12]. Market Opportunities - The U.S. market for Niktimvo in the third-line-plus setting is estimated at approximately 6,500 patients, with a frontline opportunity of around 17,000 patients, suggesting a potential approach to $1 billion in sales [5][15]. - Syndax expects to dominate the market share in NPM1-mutant AML, although it is currently too early to quantify [8]. Financial Outlook - The company has guided flat operating expenses at $400 million for 2026 and is fully funded, indicating no immediate need for additional cash [23]. - Syndax's collaboration with Incyte involves a 50/50 profit split, with expectations that 25-30% of Incyte's reported net sales will contribute to Syndax's revenue [16][17]. Clinical Development - Syndax is advancing a Phase II trial in idiopathic pulmonary fibrosis (IPF) with results expected in the second half of 2026, and a Phase II trial combining Niktimvo with Jakafi is anticipated to read out in early 2027 [18][20]. - The company is also exploring myelofibrosis treatment options, with preclinical work showing promising results [13][14].
Aethlon Medical Announces Fiscal Q3 2026 Financial Results and Corporate Update
Prnewswire· 2026-02-12 21:15
Core Insights - Aethlon Medical reported its fiscal Q3 2026 financial results, highlighting advancements in clinical and research programs, operational efficiencies, and ongoing technology development [1] Financial Performance - As of December 31, 2025, Aethlon had a cash balance of approximately $7.0 million [1] - Consolidated operating expenses for Q3 2026 were approximately $2.06 million, an increase of $250,000 or 13.6% from $1.81 million in Q3 2025, primarily due to higher payroll costs [1] - For the nine months ended December 31, 2025, consolidated operating expenses were approximately $5.36 million, a decrease of approximately $1.98 million or 26.9% compared to $7.34 million in the same period in 2024 [1] Operational Efficiency - The company maintained disciplined cost controls, resulting in a 26.9% decline in operating expenses year-to-date compared to the prior year [1] - Aethlon is actively progressing in its Australian oncology trial, with Cohort 2 enrollment and treatment underway, building on favorable results from Cohort 1 [1] Technology Development - Aethlon is evaluating the Hemopurifier® compatibility with a simplified blood treatment system under a Material Transfer Agreement, which may enhance its use in oncology units [1] - The company continues to advance its preclinical extracellular vesicle (EV) research platform, with recent findings on Long COVID published and submitted for peer review [1] Scientific Advancement - The R&D team is exploring the potential of the Hemopurifier to remove various EVs implicated in diseases beyond cancer, including Lupus and Cardiovascular Diseases [1] - Aethlon's research indicates that the Hemopurifier may serve as a "pipeline within a single device" for multiple therapeutic applications [1] Clinical Progress - The ongoing Australian oncology trial aims to evaluate the safety and feasibility of Hemopurifier treatments in patients with solid tumors [1] - The trial is designed to assess appropriate dosing in participants receiving anti-PD-1 agents [1] Nasdaq Compliance - Aethlon has maintained compliance with Nasdaq listing requirements, resolving all prior compliance matters [1]
UroGen Pharma (NasdaqGM:URGN) 2026 Conference Transcript
2026-02-12 20:30
UroGen Pharma Conference Call Summary Company Overview - **Company**: UroGen Pharma (NasdaqGM:URGN) - **Founded**: In Israel, addressing unmet needs in treating urothelial cancers - **Technology**: RTGel platform, a reverse thermal gel that allows sustained release of medications in the bladder [5][6] Core Products - **Commercial Assets**: - **Jelmyto**: Approved for low-grade upper tract urothelial carcinoma (6,000 patients in the U.S.) - **ZUSDURI**: Recently approved for low-grade intermediate-risk bladder cancer (60,000 patients in the U.S.) [7][8] Market Opportunity - **Patient Demographics**: - 60,000 newly diagnosed recurrent patients annually, with 68% having two or more recurrences [16] - 20,000 recurrent newly diagnosed patients, with a significant prevalent pool of low-grade intermediate-risk patients [16] - **Unmet Medical Need**: Historically, treatment was limited to surgical intervention (TURBT), leading to high recurrence rates [13][14] Product Launch and Performance - **ZUSDURI Launch**: - Initial revenue of $1.8 million, with October revenue reaching $4.5 million, indicating strong early performance [19] - Permanent J-code introduced in January, expected to accelerate uptake [36] - **Market Penetration**: - Estimated peak sales potential for ZUSDURI is over $1 billion, requiring only 20% market share to achieve this [37] Clinical Data and Feedback - **Efficacy**: - ZUSDURI demonstrated an 80% complete response rate, with 80% of those patients maintaining response at 12 months [25] - 90% of patients preferred ZUSDURI over TURBT based on patient-reported outcomes [25] - **Physician Feedback**: Positive reception from physicians, with many expressing enthusiasm for a non-surgical treatment option [22][25] Competitive Landscape - **Positioning**: UroGen believes ZUSDURI is the best treatment option due to its non-surgical nature and compelling clinical data [45] - **Market Growth**: The entry of additional treatments is seen as beneficial for overall market growth, with UroGen confident in its unique offering [44] Future Developments - **Next Generation Products**: - UGN-103 and UGN-104 are in development for broader applications in bladder cancer [48][51] - UGN-501, an oncolytic virus, is being explored for potential use in other cancers beyond urothelial [52] - **Long-term Strategy**: UroGen aims to diversify its portfolio while maintaining a focus on urothelial and specialty cancers [52] Financial Guidance - **Revenue Guidance**: UroGen is not providing specific revenue guidance for the upcoming year but is confident in continued growth based on current trends [39][63] Summary of Key Metrics - **ZUSDURI Market Size**: 60,000 patients, with a potential peak sales of $1.2 billion at 20% market share [37] - **Jelmyto Growth**: Continued single-digit growth, with increased physician engagement [55] This summary encapsulates the key points discussed during the UroGen Pharma conference call, highlighting the company's innovative approach to treating urothelial cancers and its strategic market positioning.
Karyopharm Therapeutics(KPTI) - 2025 Q4 - Earnings Call Presentation
2026-02-12 13:00
Fourth Quarter 2025 Financial Results & Business Update February 12, 2026 On Today's Call • Welcome Brendan Strong, SVP, Investor Relations • Overview Richard Paulson, President and Chief Executive Officer • Pipeline Update Dr. Reshma Rangwala, Chief Medical Officer and Head of Research • Commercial Highlights and Myelofibrosis Commercial Opportunity Sohanya Cheng, Chief Commercial Officer and Head of Business Development • Financial Results and Guidance Lori Macomber, Chief Financial Officer and Treasurer ...
AIM ImmunoTech to Participate in the Corporate Connect Webinar Series Virtual Conference Hosted by Webull Financial
Globenewswire· 2026-02-06 13:55
Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [3] - The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator, showing broad spectrum activity in clinical trials [3] Upcoming Event - AIM will participate in the Corporate Connect Webinar Series hosted by Webull Financial on February 10-11, 2026 [1] - Thomas K. Equels, the CEO of AIM, will provide a corporate overview and business outlook, with a focus on the company's strategic emphasis on pancreatic cancer [1] - The presentation is scheduled for February 11, 2026, at 1:40 PM EST [1]
AIM ImmunoTech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca's Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
Globenewswire· 2026-02-05 13:40
Core Insights - AIM ImmunoTech Inc. reported positive data from the ongoing Phase 2 clinical study of Ampligen combined with AstraZeneca's Imfinzi for treating metastatic pancreatic cancer, showing median survival of 19.7 months compared to 8.6 months with standard care [1][2] - The study aims to assess the clinical benefit rate, overall survival, progression-free survival, immune monitoring, and quality of life for patients [2][3] Group 1: Clinical Study Details - The DURIPANC study is an exploratory, open-label trial expected to enroll up to 25 subjects, with 18 patients already enrolled [3] - The study has shown promising results in progression-free survival and overall survival, with no significant toxicity reported, indicating a favorable safety profile [3][4] - The combination therapy appears to enhance the body's immune response, suggesting a coordinated activation of both innate and adaptive immune systems [5] Group 2: Market Potential and Intellectual Property - AIM holds a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, extending protection until August 9, 2039 [7] - The company has received orphan drug designations in pancreatic cancer from both the U.S. and EU, providing market exclusivity post-commercial approval [7][8] - AIM believes that advancing Ampligen to Phase 3 clinical trials could present significant financial opportunities for the company and its shareholders [5][8]