– PDUFA action date set for October 25, 2025 – – sNDA being reviewed under FDA’s RTOR program – – Revumenib has the potential to become the first and only menin inhibitor approved in both R/R mNPM1 AML and R/R KMT2Ar acute leukemia – NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemen ...

行业研究丨专题报告丨医疗保健 [Table_Title] 药品产业链周度系列（四） 初探 Menin 抑制剂 报告要点 [Table_Summary] Menin 是一类关键表观遗传调控因子，在 KMT2A 重排与 NPM1 突变等急性白血病亚型中驱动 HOX/MEIS1 轴异常激活，是精准治疗 AML 的重要靶点。截至 2025 年 6 月，全球共有 9 款 Menin 抑制剂处于临床研发或已上市阶段，Revumenib 联合阿扎胞苷与维奈克拉治疗急性白血 病患者的 CRc 率为 81%，mOS 达 15.5 个月；Ziftomenib 联合"7+3"方案用于初诊 NPM1m 患者的 CRc 率高达 94%；BN104 在 KMT2A 重排复发难治人群中实现 CR/CRh 率为 60.9%， 安全性良好，具备 BIC 潜力。 分析师及联系人 [Table_Author] 彭英骐 徐晓欣 张楠 万梦蝶 刘长洪 SAC：S0490524030005 SAC：S0490522120001 SAC：S0490524070006 SAC：S0490525050001 SFC：BUZ392 [Table_Title 药 ...

– Revumenib was generally well-tolerated in combination with venetoclax/azacitidine in older, newly diagnosed mNPM1 and KMT2Ar AML patients – – Promising clinical activity and deep responses observed with 67% (29/43) CR rate, 88% (38/43) ORR, and 100% (37/37) MRD negativity among responders – – Enrollment underway in pivotal Ph 3 EVOLVE-2 trial evaluating revumenib with ven/aza in newly diagnosed mNPM1 AML patients unfit for intensive chemotherapy – NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharma ...

– 26% (20/77) CR+CRh rate and 48% (37/77) ORR in efficacy-evaluable pivotal R/R mNPM1 AML population – – Robust responses observed across subgroups, regardless of co-mutations, number of prior lines of therapy, or prior venetoclax, within efficacy-evaluable pivotal R/R mNPM1 AML population – – 60% (3/5) ORR in Ph 1 patients with R/R NUP98r AML – NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapi ...

Group 1 - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [2] - Syndax is committed to advancing cancer care and is conducting several clinical trials across various treatment stages [2] Group 2 - Michael A. Metzger, CEO of Syndax, and the management team will participate in investor conferences, including the Jefferies Global Healthcare Conference on June 5, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025 [1][3] - A live webcast of the fireside chats will be available on the company's website, with replays accessible for a limited time [1]

– Revumenib abstracts highlight compelling results in acute leukemia across the frontline and R/R setting and multiple genetic populations, including mNPM1, KMT2Ar, and NUP98r – – Axatilimab abstracts highlight the robust responses observed in different organs and subgroups of patients with chronic GVHD in the AGAVE-201 trial – NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced ...

- Dr. Nicholas Botwood comes to Syndax from BMS and brings 25 years of industry experience leading drug development, R&D strategy and global commercialization of novel oncology therapeutics - NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced the appointment of Dr. Nicholas Botwood BSc (Hons), MBBS, MFPM, FRCP, to the role of Head of Research and Development (R&D) and Chief Medi ...

NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that Michael A. Metzger, Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in the following upcoming investor conferences: Bank of America Merrill Lynch Vegas Health Care Conference with a fireside chat on Thursday, May 15, 2025, at 9:20 a.m. PT/ 12:20 p.m. ET.TD Cowen 6th Annu ...

– Primary endpoint met in R/R mNPM1 AML patients in pivotal Phase 2 portion of the AUGMENT-101 trial – – Robust remission rates in heavily pre-treated R/R mNPM1 AML population with nearly 50% overall response rate – – sNDA for revumenib in R/R mNPM1 AML submitted in April 2025 – NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that data from the pivotal Phase 2 portion of the ...

First Quarter 2025 Financial Results Presentation / May 5, 2025 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events, progress, timing or circumstances) are intended to identify forward-looking statements. All statements other than statements of hi ...