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Syndax to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call and Webcast on February 26, 2026
Globenewswire· 2026-02-19 12:00
NEW YORK, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that it will report its fourth quarter and full year 2025 financial results and provide a business update on Thursday, February 26, 2026. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, February 26, 2026. The live audio webcast and acco ...
Karyopharm Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Company Progress
Prnewswire· 2026-02-12 12:30
Core Insights - Karyopharm Therapeutics reported its financial results for Q4 and full year 2025, highlighting significant revenue growth and upcoming clinical milestones for its lead product, XPOVIO (selinexor) [1][2] Financial Performance - Total revenue for Q4 2025 was $34.1 million, up from $30.5 million in Q4 2024, while full-year revenue reached $146.1 million compared to $145.2 million in 2024 [2][5] - U.S. net product revenue for XPOVIO was $32.1 million in Q4 2025, compared to $29.3 million in Q4 2024, and $114.9 million for the full year, up from $112.8 million in 2024 [2][5] - The company expects total revenue for 2026 to be between $130 million and $150 million, with U.S. XPOVIO net product revenue projected between $115 million and $130 million [1][2] Research and Development Highlights - The Phase 3 SENTRY trial for myelofibrosis is expected to report top-line data in March 2026, with the potential to introduce the first combination therapy in this area [1][3] - The Phase 3 XPORT-EC-042 trial for endometrial cancer is on track to report top-line data in mid-2026, focusing on a biomarker-driven patient population [1][3] - Enrollment in the Phase 3 XPORT-MM-031 trial for multiple myeloma was completed in Q4 2024, with top-line data anticipated in the second half of 2026 [1][3] Operational Objectives - The company aims to maintain its commercial foundation in the competitive multiple myeloma market and drive increased revenues for XPOVIO [2][3] - Karyopharm plans to support global launches of XPOVIO in ex-U.S. territories following regulatory approvals [2][3] Market Context - Myelofibrosis affects approximately 20,000 patients in the U.S., with significant unmet needs in treatment options [3] - Endometrial cancer is the most common gynecologic malignancy in the U.S., with rising incidence and mortality rates, highlighting the need for effective therapies [3][4]
Syndax Reports Preliminary 2025 Financial Highlights and Provides Business Updates at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-12 12:00
Core Insights - Syndax Pharmaceuticals reported preliminary, unaudited financial results for Q4 2025 and full year 2025, highlighting significant revenue growth for its products Revuforj and Niktimvo, driven by increased demand following FDA approvals [1][2][5] Financial Performance - Revuforj generated approximately $44 million in Q4 2025 and $125 million for the full year 2025, with a 38% increase in Q4 revenue compared to Q3 2025 [1][5] - Niktimvo reported approximately $56 million in Q4 2025 and $152 million for the full year 2025, with Syndax expecting to report its 50% share of net commercial profit in the full year results [1][4][6] - The company ended 2025 with approximately $394 million in cash, cash equivalents, and marketable securities, indicating a fully funded position through profitability [1][13] Business Developments - The company secured its third FDA approval in 2025 and successfully launched Revuforj and Niktimvo, positioning itself for continued growth [2] - Revuforj received the 'Best New Drug' award at the Scrip Awards 2025, recognizing its therapeutic advancements [5] - Syndax initiated the REVEAL-ND Phase 3 trial for revumenib in newly diagnosed patients with NPM1m AML, aiming for accelerated approval [5][12] Future Outlook - The company plans to present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, to discuss its business updates and future strategies [1][10] - Key priorities for 2026 include driving revenue growth for Revuforj and Niktimvo, completing clinical trials, and advancing pipeline development [13][14]
Karyopharm Announces Preliminary Unaudited 2025 Revenue and Reiterates Expectation of Delivering Potentially Transformative Phase 3 Data in 2026
Prnewswire· 2026-01-12 12:00
Core Insights - Karyopharm Therapeutics anticipates a transformative year in 2026, with significant data readouts from two Phase 3 trials expected, which could redefine treatment standards in myelofibrosis and endometrial cancer [2][10] Financial Performance - Preliminary unaudited total revenue for 2025 is estimated at approximately $145 million, with U.S. XPOVIO net product revenue expected to be around $115 million [1][14] - The company completed strategic financing transactions that extended its cash runway beyond the expected top-line readout of the Phase 3 SENTRY trial [14] Clinical Trials and Developments - The Phase 3 SENTRY trial for myelofibrosis has completed enrollment with 353 patients, evaluating selinexor in combination with ruxolitinib [6][17] - Top-line data from the SENTRY trial is expected in March 2026, which could significantly impact patient outcomes [2][10] - The Phase 3 XPORT-EC-042 trial for endometrial cancer is on track to report top-line data in mid-2026, focusing on a biomarker-driven patient population [2][20] Market Position and Strategy - Demand for XPOVIO remained consistent in 2025 compared to 2024, with approximately 60% of overall net product revenue driven by the community setting [6] - Global patient access for selinexor expanded in 2025, with favorable reimbursement decisions in Spain and China, and approvals in over 50 countries [6][24] Product Information - XPOVIO (selinexor) is a first-in-class oral exportin 1 inhibitor approved for multiple oncology indications, including multiple myeloma and diffuse large B-cell lymphoma [24][29] - The company is actively preparing for regulatory filings and commercialization efforts related to its ongoing clinical trials [2][10]
Arcus Biosciences, Inc. (NYSE:RCUS) Faces Setback but Remains Focused on Future Developments
Financial Modeling Prep· 2025-12-13 00:07
Core Viewpoint - Arcus Biosciences, Inc. is facing challenges following the discontinuation of its Phase 3 STAR-221 study, which has negatively impacted investor sentiment and stock performance, despite a previously strong market position. Group 1: Stock Performance - Truist Financial has set a price target of $30 for Arcus Biosciences (RCUS), indicating a potential upside of 34.74% from its current trading price of $22.27 [1][5] - Following the announcement of the study's discontinuation, RCUS stock experienced a significant decline, dropping to $21.77, a decrease of 13.42% or $3.38 from its previous value [2][3] - The stock fluctuated between $20.35 and $24 during the trading day, reflecting market volatility [3] Group 2: Study Discontinuation - Arcus announced the discontinuation of its Phase 3 STAR-221 study in collaboration with Gilead Sciences, as the Independent Data Monitoring Committee found no improvement in overall survival with the tested combination [2][5] - The decision to halt the study has adversely affected investor sentiment, despite the safety profiles being similar [2] Group 3: Future Focus - Arcus is shifting its focus to research and development investments in Casdatifan and its emerging inflammation and immunology portfolio [4][5] - The company's market capitalization is approximately $2.35 billion, with a trading volume of 5,619,062 shares on the day of the announcement [4]
Crescent Biopharma to Present at November Investor Conferences
Globenewswire· 2025-11-05 12:30
Core Insights - Crescent Biopharma is focused on advancing innovative therapies for cancer patients, with a vision to become a leading oncology company [2] Company Overview - Crescent Biopharma's pipeline includes a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates (ADCs) aimed at treating various solid tumors [2] - The company utilizes multiple modalities and established targets to develop transformative therapies, either as standalone treatments or in combination regimens [2] Upcoming Events - Crescent Biopharma will present at several investor conferences in November 2025, including: - Guggenheim 2 Annual Healthcare Innovation Conference on November 11, 2025, at 8:00 a.m. ET in Boston [3] - Stifel 2025 Healthcare Conference on November 12, 2025, at 1:20 p.m. ET in New York [3] - Jefferies Global Healthcare Conference on November 19, 2025, at 9:30 a.m. GMT (4:30 a.m. ET) in London [3]
Syndax Announces Compelling Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) Data Accepted for Presentation at ASH 2025
Globenewswire· 2025-11-03 14:08
Core Insights - Syndax Pharmaceuticals announced the acceptance of 23 abstracts, including six oral presentations, for the 67th American Society of Hematology (ASH) Annual Meeting, highlighting the company's advancements in menin inhibition and CSF-1R inhibition [1][2] Revumenib - Revumenib abstracts demonstrate promising results across various acute leukemia subtypes, including relapsed/refractory (R/R) settings and post-HSCT scenarios [1][2] - New frontline datasets will showcase the tolerability of Revumenib in combination with standard therapies, achieving high rates of complete remission and minimal residual disease (MRD) negativity [2][5] - The first real-world evidence for a menin inhibitor will be presented, along with a retrospective review of its use in post-transplant settings [2][5] - Key presentations include a Phase 2 study of Revumenib combined with venetoclax and decitabine/cedazuridine in newly diagnosed acute myeloid leukemia (AML) [7] - Additional presentations will cover efficacy and safety by leukemia type in patients with R/R KMT2Ar acute leukemia [7] Axatilimab - Axatilimab abstracts will focus on its long-term benefits in R/R chronic graft-versus-host disease (GVHD) and its tolerability when combined with ruxolitinib in newly diagnosed chronic GVHD [1][2] - An oral presentation will detail the safety and feasibility of transitioning dosing from 0.3 mg/kg every 2 weeks to 0.6 mg/kg every 4 weeks in the pivotal Phase 2 AGAVE-201 trial [4][10] - Presentations will also include interim safety analyses from a Phase 2 trial of axatilimab combined with ruxolitinib in newly diagnosed chronic GVHD [8][10] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with a pipeline that includes Revuforj (revumenib) and Niktimvo (axatilimab) [44] - The company is committed to advancing its clinical trials across various treatment landscapes, aiming to unlock the full potential of its product candidates [44]
Syndax to Announce Third Quarter 2025 Financial Results and Host Conference Call and Webcast on November 3, 2025
Globenewswire· 2025-10-27 11:00
Core Insights - Syndax Pharmaceuticals will report its third quarter 2025 financial results and provide a business update on November 3, 2025 [1] - A conference call and live audio webcast will be hosted by Syndax's management at 4:30 p.m. ET on the same day [1] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [3] - The company's pipeline includes Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody targeting the CSF-1 receptor [3] - Syndax is committed to advancing cancer care and is conducting several clinical trials across various treatment stages [3]
Adlai Nortye to Present Short Talk at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-14 03:07
Core Insights - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies and will present at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1][2] Company Overview - Adlai Nortye operates globally with R&D centers in the U.S. and China, advancing a portfolio of innovative drug candidates in two key therapeutic areas: next-generation PD-1/L1 modulation and RAS-targeted therapies [3] - Key drug candidates include AN8025, a multifunctional fusion protein for T cell and antigen-presenting cell modulation; AN4005, a first-in-class oral small-molecule PD-L1 inhibitor; AN9025, an oral pan-RAS(ON) inhibitor; and AN4035, a novel CEACAM5-targeting antibody-drug conjugate [3]
Starpharma Announces a Collaboration and License Agreement with Genentech
Globenewswire· 2025-09-22 11:30
Core Insights - Starpharma has signed a collaboration and license agreement with Genentech to develop cancer therapies using its proprietary DEP drug delivery technology [1] - The agreement includes an upfront payment of USD $5.5 million and potential milestones totaling up to USD $564 million, along with tiered royalties on global net sales [2][3] Company Overview - Starpharma is an innovative Australian biotechnology company focused on developing dendrimer-drug conjugates that incorporate Genentech medicines for oncology targets [3] - The DEP platform technology offers benefits such as improved solubility, increased efficacy, pharmacokinetic control, and better toxicity profiles, applicable to various drug classes [4] Strategic Goals - A key strategic priority for Starpharma is to establish high-impact partnerships to maximize the potential of its DEP platform, aiming to expand market reach and improve patient therapies [7] - The collaboration with Genentech is seen as a recognition of Starpharma's technology and a continuation of three years of collaborative research focused on cancer therapies [5][6]