Core Points - The call discusses the FDA approval of Revuforj for its second indication in treating Relapsed/Refractory NPM1 Mutated AML [1][2] - Key executives from Syndax Pharmaceuticals are present on the call, including the CEO, Head of R&D, Chief Medical Officer, Chief Commercial Officer, and Chief Financial Officer [2] Company Overview - Syndax Pharmaceuticals is actively engaging with investors regarding the recent FDA approval, indicating a focus on communication and transparency [2][3] - The company has provided a slide deck on its Investor page, suggesting a structured approach to presenting information to stakeholders [3]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Summary of Syndax Pharmaceuticals Conference Call on Revuforge Approval Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS: SNDX) - **Product**: Revuforge, a first-in-class menin inhibitor - **Date of Call**: October 24, 2025 Key Industry and Company Insights FDA Approval and Indications - Revuforge received FDA approval for its second indication, targeting adults and pediatric patients with relapsed or refractory NPM1 mutated acute myeloid leukemia (AML) [6][10] - This approval follows the initial FDA approval in November 2024 for relapsed or refractory acute leukemia patients with KMT2A translocation [6][10] - Revuforge is now the first and only menin inhibitor approved for multiple acute leukemia subtypes in both adults and pediatrics [6][10] Clinical Efficacy and Data - The approval is based on pivotal data showing a 47% overall response rate (ORR) and an 11% transplant rate in patients treated with Revuforge [8][19] - The median overall survival for responders was nearly two years, with a median duration of response of 4.5 months [19][20] - Revuforge demonstrated compelling efficacy across multiple genetic subtypes of acute leukemia, establishing a strong clinical profile [8][20] Market Opportunity - The total addressable population for Revuforge has expanded from approximately 2,000 KMT2A incident patients to 6,500 patients, representing a market opportunity exceeding $2 billion in the relapsed refractory setting [25][26] - Approximately 40-45% of AML patients have either an NPM1 mutation or a KMT2A translocation, indicating a significant market potential [26] Commercial Strategy and Execution - Syndax has established a strong commercial foundation with a trusted presence in leading cancer centers across the U.S. [10][28] - The company has achieved nearly $50 million in net revenue in the first two full quarters post-launch, despite some KMT2A patients pausing treatment for transplants [27][28] - Revuforge is on formulary for 97% of covered lives, facilitating rapid access for patients [29][30] Safety Profile and Monitoring - The updated label includes a boxed warning for QTc prolongation and torsades de pointes, based on a non-fatal case identified during clinical trials [16][51] - Management of QTc prolongation remains straightforward, with physicians already familiar with monitoring protocols [41][51] Future Outlook - Syndax plans to expand Revuforge into additional indications and frontline settings, with ongoing clinical trials [11][35] - The company is positioned for continued growth, with a strong pipeline and a focus on innovative therapies for difficult-to-treat diseases [24][35] Additional Important Points - The NCCN Guideline Committee has added Revuforge as a recommended treatment option for relapsed refractory NPM1 mutated AML, validating the strength of the clinical data [10][11] - The company has a comprehensive clinical development plan aimed at unlocking a market opportunity exceeding $5 billion in the U.S. [11] - Syndax's commercial team has extensive experience in hematology and oncology, enhancing their ability to engage with healthcare providers effectively [32][34] This summary encapsulates the critical insights from the conference call regarding Syndax Pharmaceuticals, its product Revuforge, and the broader implications for the acute leukemia treatment landscape.

FDA Approval of Revuforj® (revumenib) in R/R NPM1 Mutated AML October 24, 2025 2 Agenda for today's call Opening Remarks & Key Highlights Michael Metzger, Chief Executive Officer 2 Revuforj (revumenib) Label & Supporting Data Dr. Nick Botwood, Head of R&D and Chief Medical Officer 3 Delivering Revuforj to Patients Steve Closter, Chief Commercial Officer Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform A ...

Core Insights - Syndax Pharmaceuticals has received FDA approval for Revuforj (revumenib) as the first and only therapy for both relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation, marking a significant advancement in treatment options for these aggressive blood cancers [2][3][4] Company Developments - Revuforj is now approved for use in adult and pediatric patients aged one year and older who have no satisfactory alternative treatment options, expanding its indication from a previous approval for R/R acute leukemia with a KMT2A translocation [2][11] - The approval is based on data from the Phase 2 portion of the AUGMENT-101 trial, which demonstrated a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% among patients with R/R NPM1 mutated AML [3][4] - The median time to CR or CRh response was reported at 2.8 months, with a median duration of 4.5 months [3] Industry Impact - The inclusion of Revuforj in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a category 2A recommended treatment option for R/R NPM1 mutated AML and R/R acute leukemia with a KMT2A rearrangement underscores its significance in the oncology landscape [5][6] - The approval of Revuforj is expected to set a new standard of care for patients with these difficult-to-treat blood cancers, as highlighted by experts in the field [4][5] - The company is committed to supporting patient access through its SyndAccess program, which provides personalized support and financial assistance for eligible patients [8]

MicroStockHub/iStock via Getty Images Listen here or on the go via Apple Podcasts and Spotify How to trade and invest in the biotech space with ROTY Biotech Community's Jonathan Faison (0:35). Making money in biotech (5:40). Managing sector risk (9:20). Geron - a stock he never thought he'd own (17:10). Transcript Rena Sherbill: Jonathan Faison from ROTY Biotech Community on Seeking Alpha. That's the investing group you run. Jonathan, welcome back to Investing Experts. Jonathan Faison: Thank you, Ren ...

MicroStockHub/iStock via Getty Images Listen here or on the go via Apple Podcasts and Spotify How to trade and invest in the biotech space with ROTY Biotech Community's Jonathan Faison (0:35). Making money in biotech (5:40). Managing sector risk (9:20). Geron - a stock he never thought he'd own (17:10). Transcript Rena Sherbill: Jonathan Faison from ROTY Biotech Community on Seeking Alpha. That's the investing group you run. Jonathan, welcome back to Investing Experts. Jonathan Faison: Thank you, Ren ...

Core Insights - Syndax Pharmaceuticals Inc. has achieved a significant milestone with the inclusion of its drug Revuforj (revumenib) in the NCCN Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) [1][3] - Revumenib received a Category 2A recommendation for treating relapsed or refractory AML with an NPM1 mutation, based on positive results from the AUGMENT-101 trial [2][3] - The FDA has granted Priority Review for Syndax's supplemental New Drug Application for revumenib, with a target action date set for October 25, 2023 [3] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing cancer therapies [4] - The company is currently positioned in a competitive market, with some analysts suggesting that certain AI stocks may offer greater upside potential compared to Syndax [4]

Core Insights - Syndax Pharmaceuticals announced that revumenib has been included as a category 2A recommendation in the NCCN Guidelines for relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, highlighting the drug's clinical significance [1][2] - The company has submitted a supplemental New Drug Application (sNDA) for revumenib, which has been granted Priority Review by the FDA, with a target action date of October 25, 2025 [2][6] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with revumenib being a first-in-class menin inhibitor approved for certain types of acute leukemia [5][23] - The company is actively conducting multiple clinical trials to explore revumenib's efficacy in various treatment settings, including combinations with standard therapies for newly diagnosed patients [7][24] Industry Context - The NCCN is a not-for-profit alliance of 33 leading cancer centers that develops clinical practice guidelines to inform treatment decisions for healthcare stakeholders [3] - Mutant NPM1 (mNPM1) AML is a prevalent genetic alteration in AML, affecting approximately 30% of adult patients, and is associated with a poor prognosis and high relapse rates [4]

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] Group 2 - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] - The analyst has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3]