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Exelixis: The Cash‑Generating Biotech That I Think Deserves a Closer Look in 2026
Yahoo Finance· 2026-02-20 21:05
While not the most popular biotech company on the market, Exelixis (NASDAQ: EXEL) has been quietly making a name for itself over the past five years, while delivering strong financial results and solid returns. The good news is that the company could still have plenty of room to grow, and that's why it deserves a closer look this year. Let's dig deeper into Exelixis. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now, when you join St ...
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
Prnewswire· 2026-02-20 07:00
Core Insights - The FDA has approved the combination treatment of VENCLEXTA® (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia (CLL), marking a significant advancement in treatment options [1][2] Group 1: FDA Approval and Treatment Significance - The approval is based on data from the Phase 3 AMPLIFY trial, establishing this regimen as the first all-oral, fixed-duration treatment for previously untreated CLL patients [1] - This combination offers patients the potential for time off treatment, enhancing long-term disease management [1][3] - The approval expands treatment choices for patients and healthcare providers, facilitating more targeted treatment decisions in CLL [1][3] Group 2: AMPLIFY Study Details - The AMPLIFY trial evaluated VENCLEXTA plus acalabrutinib against chemoimmunotherapy in previously untreated CLL patients without del(17p) or TP53 mutation [1] - Results indicated that the combination regimen reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.0038) [1] - Median progression-free survival (PFS) was not reached for the combination regimen, while it was 47.6 months for chemoimmunotherapy [1] Group 3: Safety Profile - The safety profile of the combination regimen aligns with the known safety profiles of each individual therapy [1] - Common adverse reactions (20%) include neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19 [1] - Serious adverse reactions (2%) include COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%) [1]
Sensei Biotherapeutics (NasdaqGM:SNSE) M&A announcement Transcript
2026-02-18 14:32
Summary of Sensei Biotherapeutics and Faeth Therapeutics Acquisition Conference Call Company and Industry Overview - **Company**: Sensei Biotherapeutics (NasdaqGM:SNSE) - **Acquisition Target**: Faeth Therapeutics - **Industry**: Biotechnology, specifically focused on cancer treatment Key Points and Arguments 1. **Acquisition Announcement**: Sensei Biotherapeutics announced the acquisition of Faeth Therapeutics, which includes a concurrent financing and changes to the leadership team and board of directors [2][6] 2. **Strategic Rationale**: The acquisition is seen as a means to maximize shareholder value and is expected to create significant value for stockholders [6] 3. **Faeth's Pipeline**: Faeth is a clinical-stage company developing multi-node therapies aimed at blocking cancer growth signals, with its lead asset, PIKTOR, showing promising safety and efficacy data [6][7] 4. **Financing Details**: Sensei entered into a $200 million private placement with support from leading healthcare investors, which will strengthen its financial position [8] 5. **Cash Runway**: The combined cash from the private placement and existing funds is expected to extend Sensei's cash runway through multiple clinical milestones [8] 6. **Leadership Changes**: Anand Parikh, former CEO and co-founder of Faeth, has joined Sensei as COO and a board member [9] 7. **PIKTOR Overview**: PIKTOR is an investigational oral combination therapy targeting the PI3K/AKT/mTOR pathway, designed to improve tolerability and efficacy compared to traditional treatments [10] 8. **Clinical Trial Results**: In a phase 1b trial, PIKTOR achieved a 47% overall response rate in heavily pre-treated patients with various cancers, including an 80% response rate in endometrial cancer patients [11] 9. **Future Trials**: PIKTOR is currently in phase 2 trials for endometrial cancer, with plans for additional studies in breast cancer and other tumor types [12] 10. **Market Potential**: The focus on cancers with mutations in the PI3K/AKT/mTOR pathway presents a significant market opportunity, particularly as treatment standards evolve towards combination strategies [13] 11. **Preclinical Pipeline**: In addition to PIKTOR, Sensei has a preclinical pipeline that includes therapies for rectal cancer and pediatric rare diseases [13] 12. **Acquisition Structure**: The acquisition was structured as a stock-for-stock merger, with Faeth's equity exchanged for Sensei common stock and newly created Series B non-voting convertible preferred stock [15] 13. **Ownership Post-Acquisition**: Post-acquisition, Faeth's equity holders will own approximately 40.8% of Sensei's common stock, while private placement investors will own about 54.3% [17] 14. **Use of Proceeds**: Proceeds from the private placement will primarily be used to advance PIKTOR for key clinical readouts [17] Additional Important Information - **Forward-Looking Statements**: The call included forward-looking statements regarding the expected effects and opportunities related to the acquisition, which involve risks and uncertainties [3][4] - **Investor Communication**: Investors are encouraged to read the proxy statement and other relevant materials filed with the SEC for important information regarding the transactions [5] - **Future Updates**: Sensei plans to provide updates on the progress of its clinical trials and the integration of Faeth in the coming weeks and months [19]
Will Tavalisse Continue to Drive Rigel Pharmaceuticals' Growth in 2026?
ZACKS· 2026-02-18 14:15
Key Takeaways Rigel Pharmaceuticals expects 2025 sales to rise 60% to $232M, topping prior guidance.Tavalisse drove $158.9M in 2025 sales, up 52%, while Gavreto and Rezlidhia added momentum.RIGL guides 2026 product sales of $255-$265M but faces competition from Sanofi and Eli Lilly drugs.Rigel Pharmaceuticals (RIGL) had an encouraging year in 2025. The company is yet to report its fourth-quarter and full-year 2025 results, but preliminary figures released last month point to another strong finish — driven p ...
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
On February 13, 2026, First Turn Management, LLC disclosed in an SEC filing that it sold out of Arcellx (NASDAQ:ACLX), selling all 313,733 shares in an estimated $25.76 million transaction. What happened According to a recent SEC filing dated February 13, 2026, First Turn Management reported selling its entire stake of 313,733 shares in Arcellx. The fund’s quarter-end position in Arcellx declined by $25.76 million, a change that reflects both the sale and movement in the underlying share price. What els ...
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
DOYLESTOWN, Pa., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, today announced that Oren Gilad, Ph.D., President and CEO, will provide a corporate update at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, to take place February 25-26, 2026, virtually. Presentation Details Date ...
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]