This Biotech Stock Winner Is Up 72%, but a $4 Million Trim Signals a Slight Reset | The Motley Fool This clinical-stage biotech develops oncology therapies targeting unmet needs in cancer and immune-mediated conditions.

#SNDX #c210fd9c-7df5-48e9-9a07-4d31373eb8fb #coveragefilings

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Syndax Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Syndax (NASDAQ: SNDX) reported Q4 2025 revenue $68.7M and FY2025 revenue $172.4M, driven by Revuforj net sales of $44.2M in Q4 ($124.8M FY2025) and Niktimvo net sales of $56.0M in Q4 ($151.6M FY2025).The company had $394.1M in cash and equivalents at year-end, completed Phase 2 IPF enrollment for axatilimab, and expects 2026 R&D plus SG&A of ~$400M while targeting profitability from product and collaboration revenue.

#SNDX Syndax Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

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Syndax and World Orphan Drug Alliance to Launch a Multi-Regional Managed Access Program, Expanding Access to Revuforj® (revumenib) Outside the U.S. Syndax (Nasdaq: SNDX) and the World Orphan Drug Alliance announced a multi-regional Managed Access Program to expand patient access to Revuforj (revumenib) outside the U.S. The program will operate where local rules permit and funding is secured and launches in parts of Eurasia, Central and Southeast Europe, Israel, the Middle East and Turkey, Latin America, and Africa. WODA will administer named-patient supply through its network and the program will follow local regulatory and ethical frameworks. U.S. FDA approvals for Revuforj in specified relapsed/refractory KMT2A‑translocated and NPM1‑mutated acute leukemias are noted. Physicians should contact medinfo@syndax.com for details; patients must contact their physician.

#SNDX Syndax and World Orphan Drug Alliance to Launch a Multi-Regional Managed Access Program, Expanding Access to Revuforj® (revumenib) Outside the U.S.

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Syndax Highlights Leadership in Menin Inhibition at ASH 2025 with Multiple Revuforj® (revumenib) Presentations Spanning the Acute Leukemia Treatment Continuum Syndax (NASDAQ: SNDX) presented 12 Revuforj (revumenib) abstracts at ASH 2025 covering real-world, post‑HSCT maintenance, and combination trials in NPM1m, KMT2Ar and NUP98r acute leukemias.Key disclosed results: real‑world ORR 77% (10/13) and 75% MRD negativity; pediatric post‑HSCT maintenance cohort: 100% alive and 90% relapse‑free at median 19 months; Phase 2 SAVE (revumenib+venetoclax+HMA) in newly diagnosed unfit patients: ORR 86% (18/21), CR 76% (16/21), 100% MRD negativity among responders; Phase 1 with intensive chemo: ORR 96% (25/26), CRc 92% (24/26), MRD‑negative CR 86% (12/14).

#SNDX Syndax Highlights Leadership in Menin Inhibition at ASH 2025 with Multiple Revuforj® (revumenib) Presentations Spanning the Acute Leukemia Treatment Continuum

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Pretty clear we are rotating into a new phase of the #stock #market where #biotech is leading (specifically Life Sciences/genomics). Initiated new position in #GRAL.
Watchlist: #IRWD #CMBM #PHAT #SNDX #APPN #TDC #VICR #CRK #LQDA.
#swing #trading

Syndax Reports Third Quarter 2025 Financial Results and Provides Business Update Syndax (Nasdaq: SNDX) reported $45.9M total revenue for 3Q25, including $32.0M Revuforj net revenue and $13.9M collaboration revenue from Niktimvo. Revuforj prescriptions rose ~25% QoQ (~850 scripts) and Revuforj received FDA approval on Oct 24, 2025 and NCCN category 2A listing for R/R NPM1m AML. Incyte reported $45.8M Niktimvo net sales; Syndax recorded 50% product contribution. Cash, cash equivalents and investments were $456.1M, which the company expects will fund it to profitability. Reported 3Q25 net loss was $60.7M. Conference call held Nov 3, 2025.

#SNDX Syndax Reports Third Quarter 2025 Financial Results and Provides Business Update

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Syndax Announces Compelling Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) Data Accepted for Presentation at ASH 2025 Syndax (Nasdaq: SNDX) announced that 23 abstracts, including 6 oral presentations, featuring Revuforj (revumenib) and Niktimvo (axatilimab) data were accepted for presentation at the ASH Annual Meeting, Dec 6-9, 2025 in Orlando.Revumenib abstracts cover frontline and relapsed/refractory acute leukemia, combination regimens (venetoclax + decitabine/cedazuridine; intensive chemo; gilteritinib), real-world experience, and post-HSCT maintenance. Axatilimab abstracts address dosing feasibility, long-term therapy in R/R chronic GVHD, combination with ruxolitinib in newly diagnosed chronic GVHD, biomarker/pharmacodynamic analyses, and a Phase 3 trial in initial therapy.The company will host an in-person investor event with a live webcast on Dec 8, 2025 at 7:00 a.m. ET.

#SNDX Syndax Announces Compelling Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) Data Accepted for Presentation at ASH 2025

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Syndax Announces Participation in November Investor Conferences Syndax (Nasdaq: SNDX) announced management will participate in multiple investor conferences in November 2025, featuring fireside chats by CEO Michael A. Metzger and other executives.Scheduled appearances: UBS Global Healthcare Conference on Nov 10, 2025 at 11:00 a.m. ET; Guggenheim Healthcare Innovation on Nov 11, 2025 at 3:00 p.m. ET; Stifel Healthcare Conference on Nov 13, 2025 at 10:00 a.m. ET; and Jefferies London Healthcare Conference on Nov 20, 2025 at 10:00 a.m. GMT / 5:00 a.m. ET.A live webcast and limited-time replay will be available in the Investor section at www.syndax.com.

#SNDX Syndax Announces Participation in November Investor Conferences

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Syndax Announces FDA Approval of Revuforj® (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia Syndax (NASDAQ: SNDX) announced FDA approval of Revuforj (revumenib) on October 24, 2025 for treatment of relapsed or refractory (R/R) acute myeloid leukemia with a susceptible NPM1 mutation in adults and pediatric patients one year and older with no satisfactory alternative options.The approval expands Revuforj’s prior 2024 indication for R/R acute leukemia with a KMT2A translocation, making it the first FDA-approved menin inhibitor for multiple acute leukemia subtypes. Approval was supported by AUGMENT-101 Phase 2 data showing CR+CRh 23% (15/65), median time to response 2.8 months, and median duration of response 4.5 months. Revuforj is included in the NCCN Guidelines as a category 2A option for R/R NPM1m AML and KMT2A-rearranged acute leukemia.

#SNDX Syndax Announces FDA Approval of Revuforj® (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia

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Cancer Therapy Developer Syndax Pharmaceuticals Sets Two Major September Investor Conference Appearances Syndax Pharmaceuticals' CEO Michael Metzger to present at Citi BioPharma Conference (Sept 2) and H.C. Wainwright Global Investment Conference (Sept 8). Webcasts available.

#SNDX Syndax Announces Participation in September Investor Conferences

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Leading Indicators, Tuesday August 5, 2025 – Crystal Equity Research

Small-cap stocks with strong volume gains, Tue Aug 5th - #XMTR #VANI #ALTI #CSTI #EVGO #LRMO #ORGN #PHLT #RIGL #SNDX #WHLR #TCMD #YALA #VVX #QUAD #PACK #NGVT #MBI #EQV #AMWL - More: crystalequityresearch.com/leading-indi... - #smallcap

Syndax Reports Explosive 43% Revenue Growth as Both Cancer Drugs Exceed Market Expectations Syndax delivers $28.6M Revuforj sales, secures FDA Priority Review for NPM1 AML indication. Partner reports $36.2M Niktimvo revenue. See full results.

#SNDX Syndax Reports Second Quarter 2025 Financial Results and Provides Business Update

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Leading Indicators, Tuesday July 29, 2025 – Crystal Equity Research

Small-cap stocks in new uptrend with AROON Oscillator, Tue Jul 29th - #SNDX #QIPS #PDLB #OFIX #MASS #GALT #ENLV #COMM #BTMD #AIP #XPRO #SRI #QD #PDM #MMI #NABL #LFT #INSW #FLNG #CSTM - More: crystalequityresearch.com/leading-indi... - #smallcap

Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia Syndax Pharmaceuticals (NASDAQ:SNDX) announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to treat relapsed or refractory mutant NPM1 acute myeloid leukemia.The FDA has set a PDUFA target action date of October 25, 2025. The sNDA is being reviewed under the FDA's Real-Time Oncology Review program. If approved, Revuforj would become the first and only menin inhibitor approved for both R/R mNPM1 AML and R/R KMT2Ar acute leukemia. The drug received initial FDA approval in 2024 for R/R acute leukemia with KMT2A translocation.The sNDA submission is supported by positive pivotal data from the AUGMENT-101 trial, with results published in Blood and presented at the EHA Annual Congress Meeting.

#SNDX Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia

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Syndax Announces Publication of Revumenib Data from the BEAT AML Trial in the Journal of Clinical Oncology and Simultaneous Presentation at EHA 2025 Syndax Pharmaceuticals (SNDX) announced promising results from the BEAT AML trial testing revumenib combined with venetoclax/azacitidine in older patients with newly diagnosed mNPM1 and KMT2Ar acute myeloid leukemia (AML). The study showed impressive efficacy with a 67% complete remission rate, 88% overall response rate, and 100% MRD negativity among responders. The treatment was well-tolerated, with common side effects including nausea (60%), constipation (53%), and QTc prolongation (44%). The median overall survival reached 15.5 months, significantly better than historical data. The trial included 43 patients (median age 70 years), with 79% having mNPM1 AML and 21% KMT2Ar AML. These results support the ongoing Phase 3 EVOLVE-2 trial evaluating revumenib with ven/aza in newly diagnosed mNPM1 AML patients unfit for intensive chemotherapy.

#SNDX Syndax Announces Publication of Revumenib Data from the BEAT AML Trial in the Journal of Clinical Oncology and Simultaneous Presentation at EHA 2025

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Wooden blocks spelling “AML” with a stethoscope beside them, representing Syndax Pharmaceuticals’ focus on Acute Myeloid Leukemia treatment.

#SNDX presented new data at #EHA2025 showing nearly half of patients with tough-to-treat mNPM1 AML responded to Revuforj. Median survival for responders hit 23.3 months. FDA decision expected later this year.
#Syndax
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Syndax Presents New Revuforj® (revumenib) Data in Relapsed/Refractory mNPM1 and NUP98r Acute Leukemia from AUGMENT-101 Trial at EHA 2025 Syndax Pharmaceuticals presented new data from the AUGMENT-101 trial of Revuforj (revumenib) at EHA 2025, showing promising results in treating relapsed/refractory mNPM1 and NUP98r acute leukemia. In the efficacy-evaluable pivotal R/R mNPM1 AML population (n=77), the treatment achieved a 26% CR+CRh rate and 48% overall response rate. The median overall survival was 4.8 months for all patients, extending to 23.3 months for responders. The drug demonstrated effectiveness across various subgroups, regardless of prior treatments. In Phase 1 R/R NUP98r AML patients, a 60% overall response rate was observed. Revuforj was generally well-tolerated, with only 4.8% of patients discontinuing due to treatment-related adverse events. The drug received FDA approval in November 2024 for R/R acute leukemia with KMT2A translocation.

#SNDX Syndax Presents New Revuforj® (revumenib) Data in Relapsed/Refractory mNPM1 and NUP98r Acute Leukemia from AUGMENT-101 Trial at EHA 2025

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Syndax Leadership Takes Center Stage at Major Healthcare Conferences: Key Dates for Investors Syndax CEO Metzger to share company updates at Jefferies and Goldman Sachs conferences in June. Live webcasts available. Get investment insights.

#SNDX Syndax Announces Participation in June Investor Conferences

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Syndax Announces Data Presentations at EHA 2025 Showcasing Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) Syndax Pharmaceuticals (NASDAQ: SNDX) announced multiple data presentations for its cancer therapies Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) at the upcoming 30th European Hematology Association Annual Congress in June 2025. The presentations will showcase: For Revuforj: Updated results from the BEAT AML trial combining revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients, data from 77 patients with R/R mNPM1 AML in the AUGMENT-101 trial, and outcomes in patients with R/R NUP98r acute leukemias. For Niktimvo: Data highlighting responses in different organs and subgroups of chronic GVHD patients from the AGAVE-201 trial. The company recently submitted a supplemental NDA for revumenib in R/R mNPM1 AML in April 2025.

#SNDX Syndax Announces Data Presentations at EHA 2025 Showcasing Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr)

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Syndax Announces Participation in May Investor Conferences Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on innovative cancer therapies, has announced its participation in two upcoming investor conferences in May 2025. CEO Michael A. Metzger and the management team will present at:- The Bank of America Merrill Lynch Vegas Health Care Conference on May 15, 2025, at 12:20 p.m. ET- The TD Cowen 6th Annual Oncology Innovation Summit on May 28, 2025, at 10:30 a.m. ETBoth presentations will be available via webcast on the company's website at www.syndax.com.

#SNDX Syndax Announces Participation in May Investor Conferences

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Syndax Announces Publication of Pivotal Revumenib Data in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia in the Journal Blood Syndax Pharmaceuticals (NASDAQ: SNDX) announced the publication of pivotal Phase 2 data for revumenib in the journal Blood, showing promising results in treating relapsed or refractory mutant NPM1 (mNPM1) acute myeloid leukemia (AML). The study demonstrated a nearly 50% overall response rate in heavily pre-treated patients.The company submitted a supplemental New Drug Application (sNDA) for revumenib in R/R mNPM1 AML in April 2025 under the FDA's Real-Time Oncology Review program. This follows revumenib's FDA approval as Revuforj® in November 2024 for treating R/R acute leukemia with KMT2A translocation in patients one year and older.

#SNDX Syndax Announces Publication of Pivotal Revumenib Data in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia in the Journal Blood

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Syndax Reports First Quarter 2025 Financial Results and Provides Business Update Syndax Pharmaceuticals reported strong Q1 2025 financial results, highlighting successful product launches. Revuforj generated $20.0 million in net revenue in its first full quarter, while Niktimvo achieved $13.6 million in net revenue in its partial first quarter. The company submitted an sNDA for Revuforj in R/R mNPM1 AML and initiated a pivotal frontline trial combining Revuforj with venetoclax and azacitidine. Multiple ongoing trials are evaluating both drugs across various indications. Q1 2025 showed increased R&D expenses of $61.6 million and SG&A expenses of $41.0 million. The company reported a net loss of $84.8 million ($0.98 per share). With $602.1 million in cash and investments, Syndax expects to reach profitability through current resources and anticipated product revenue.

#SNDX Syndax Reports First Quarter 2025 Financial Results and Provides Business Update

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Exclusive Look: Syndax CEO Reveals Cancer Drug Strategy at Major Healthcare Conference CEO Michael Metzger to showcase Syndax's innovative cancer therapy pipeline at Stifel's Oncology Forum. Get exclusive insights into development strategy.

#SNDX Syndax Announces Participation at the Stifel 2025 Virtual Targeted Oncology Forum

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Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Syndax Pharmaceuticals (SNDX) reported Q4 and full year 2024 results, highlighting strong initial performance of two newly launched products. Revuforj generated $7.7 million in net product revenue in its first five weeks of launch, while Niktimvo was launched in partnership with Incyte in late January 2025.The company reported Q4 2024 financial results with a net loss of $94.2 million ($1.10 per share). R&D expenses increased to $65.5 million, while SG&A expenses rose to $37.7 million. For full year 2024, net loss was $318.8 million ($3.72 per share).Key developments include positive pivotal data from AUGMENT-101 trial, with plans to submit sNDA for Revuforj in R/R mNPM1 AML in Q2 2025. The company maintains a strong financial position with $692.4 million in cash and investments, which is expected to fund operations until profitability.

#SNDX Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

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Syndax CEO to Reveal Latest Company Updates at Two Major Healthcare Investor Conferences Syndax management will present at TD Cowen on March 4 and Barclays on March 13, with live webcasts available for investors seeking company updates.

#SNDX Syndax Announces Participation in March Investor Conferences

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When Will Syndax Report Q4 Earnings? Key Date and Access Details Inside Join Syndax's Q4 earnings webcast on March 3, 2025. Get comprehensive financial results and business updates, with easy phone and online access options.

#SNDX Syndax to Announce Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call and Webcast on March 3, 2025

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Syndax Pharmaceuticals Issues New Inducement Grants Amidst Ongoing Cancer Treatment Development Syndax Pharmaceuticals has announced the granting of stock options to new employees as part of its 2023 Inducement Plan, enhancing its cancer therapies pipeline.

Syndax Pharmaceuticals Issues New Inducement Grants Amidst Ongoing Cancer Treatment Development #United_States #cancer_therapies #Waltham #Syndax_Pharmaceuticals #SNDX

Syndax Leadership Reveals Growth Strategy at Elite Healthcare Investment Forums Syndax CEO Michael Metzger to share company insights at Guggenheim SMID Cap Biotech Conference and Citi's Oncology Summit this February. Live webcasts available.

#SNDX Syndax Announces Participation in February Investor Conferences

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