Writing under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and from ~5 years of focused research on a variety of stocks, in recent years with a primary emphasis on healthcare stocks. I greatly appreciate those who take the time to share their reactions to articles, particularly those who share releva ...

Revuforj (revumenib) - Revuforj generated $20 million in net revenue in 1Q25[3] - Syndax initiated a pivotal frontline trial of revumenib with ven/aza in mNPM1 and KMT2Ar patients unfit for intensive chemo in 1Q25[3] - Syndax completed the submission of Revuforj sNDA for R/R mNPM1 AML in April 2025[3] - In the AUGMENT-101 trial, Revuforj showed a CR+CRh rate of 212% (22/104) with a median duration of 64 months[29] - In the Phase 2 portion of AUGMENT-101, revumenib demonstrated a CR/CRh of 23% (15/64) in R/R mNPM1 AML patients[47] Niktimvo (axatilimab-csfr) - Niktimvo generated $136 million in net revenue in 1Q25 (reported by Incyte)[3] - In the AGAVE-201 trial, Niktimvo showed an overall response rate of 75% (59/79) through 6 months[78] - 60% of responders maintained a response for at least 12 months[78] Financial Position - Syndax had $6021 million in cash and cash equivalents as of March 31, 2025, expected to fund the company to profitability[3] - Syndax's total revenue for 1Q25 was $20 million[102]

– 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 ...

Core Insights - Revumenib, in combination with venetoclax and azacitidine, shows promising clinical activity in older patients with newly diagnosed mNPM1 and KMT2Ar AML, achieving a 67% complete remission (CR) rate and an 88% overall response rate (ORR) [1][2][6] - The ongoing Phase 3 EVOLVE-2 trial is evaluating the efficacy of this combination in newly diagnosed mNPM1 AML patients who are unfit for intensive chemotherapy [1][2] Group 1: Clinical Trial Results - The BEAT AML trial reported a 67% CR rate (29 out of 43 patients) and an 88% ORR (38 out of 43 patients) among newly diagnosed older adults with mNPM1 or KMT2Ar AML [1][6] - Among 37 patients assessed for measurable residual disease (MRD), 100% were found to be MRD negative [6] - The median duration of composite complete remission (CRc) was 12.0 months [6] Group 2: Patient Demographics and Safety - As of September 2024, 43 patients were enrolled, with 79% having mNPM1 AML and 21% KMT2Ar AML; the median age was 70 years [4][5] - Revumenib was generally well tolerated, with common non-hematologic treatment-emergent adverse events including nausea (60%), constipation (53%), and QTc prolongation (44%) [5][6] Group 3: Comparative Outcomes - The observed median overall survival (OS) was 15.5 months, with a CRc rate of 77% in mNPM1 patients and 89% in KMT2Ar patients [7][8] - Historical data indicated lower CRc rates and median OS for patients treated with venetoclax and azacitidine alone, highlighting the potential of revumenib in improving outcomes [8] Group 4: Future Developments - Revumenib is being developed for the treatment of relapsed or refractory AML with mNPM1 mutations, with a supplemental NDA submitted in April 2025 [10] - The company is conducting multiple trials of revumenib in combination with standard-of-care agents across various treatment settings [10][25]

– 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 ...

Syndax Pharmaceuticals (SNDX) FY Conference June 11, 2025 02:00 PM ET Speaker0 Good afternoon, everyone. Thanks for joining us here at Goldman Sachs Senior Healthcare Conference. Thrilled to be joined by the team from Maybe I'll kick it off. I'll let you guys introduce yourselves and then introduce the company. Speaker1 Sure. Good to see you, Corinne. Thank you. I'm Michael Metzger. I'm the CEO of Syndax, I've been with the company about ten years. And to my left, Steve? Yes. Steve Kloster, our Speaker2 Chi ...

Syndax Pharmaceuticals (SNDX) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 Good afternoon, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Baozhi, a senior biotech analyst biotech team here. And please join me and welcome CEO, Mr. Michael Metzger CMO, Mr. Nick Batwood and COO, Mr. Steve Closter from Syndax Pharmaceuticals for this fireside chat session. Welcome. Speaker1 Thank you, Kelly. Speaker0 Maybe let's start with a high level question. Last year 2024 was a v ...

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]

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals - **Key Products**: RevuForge (Menin inhibitor for AML) and Nictimvo (for chronic GVHD) - **Market Potential**: - RevuForge: Over $5 billion market opportunity - Nictimvo: Over $3 billion market opportunity - **Current Status**: Both products are generating revenue and have FDA approval, with early launches showing positive results [3][4][7]. Core Points and Arguments RevuForge - **Product Profile**: First-in-class Menin inhibitor with a significant first-mover advantage in the market [3]. - **Clinical Data**: - Phase 1b study confirmed a dose of 160 mg in combination with Venaza, showing good tolerability and a 67% complete response (CR) rate compared to 37% historical control [11][13]. - 100% of evaluable patients achieved minimal residual disease (MRD) negativity, indicating strong efficacy [14]. - **Market Position**: Anticipated inclusion in NCCN guidelines ahead of approval, which could enhance market penetration [24][44]. Nictimvo - **Clinical Data**: - Updated data to be presented at EHA, showing a 26% CR rate and a 48% overall response rate in a larger patient population [21][22]. - Rapid symptom improvement across organ systems in chronic GVHD patients [47][48]. - **Sales Performance**: Strong initial sales with $13.6 million in net revenue for the first two months post-launch [49]. Additional Important Insights - **Regulatory Strategy**: Plans to use CR and MRD negativity as potential endpoints for accelerated approval in clinical trials [35][36]. - **Launch Metrics**: - RevuForge generated $20 million in its first full quarter, with 90% of sales from KMT2A patients and expectations for growth as NPM1 reimbursement is secured [37][42]. - High coverage rates with 72% of managed care lives covered, indicating strong market access [39]. - **Competitive Landscape**: Syndax is currently the only approved Menin inhibitor, with a best-in-class profile that physicians favor [29][30][31]. Conclusion Syndax Pharmaceuticals is well-positioned in the oncology market with its innovative products, strong clinical data, and strategic regulatory plans. The company is focused on expanding its market presence and enhancing its product offerings, which could lead to significant growth in the coming years [5][6][34].

Syndax Pharmaceuticals (SNDX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Here on this our third day of, Bank of America's twenty twenty five health care conference in Las Vegas. My name is Jason Zemanski. I'm one of the SMID cap analysts here at the bank. With me on the stage, my associate, Cameron Bozog. And for this slot, I'm very pleased to have join us Mike Mechsger, CEO of Syndax Pharmaceuticals and the rest of the Syndax team. Mike, thank you so much for joining us. Speaker1 Yes, Speaker2 Jason ...