Syndax Pharmaceuticals

Syndax Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the development of cancer therapies. Its product candidates include SNDX-5613 and SNDX-6352. The company was founded by Richard A. Heyman, Eckard Weber, Peter Ordentlich, Ronald M. Evans and Michael Downes on October 11, 2005 and is headquartered in Waltham, MA.

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Earnings data Q4 2024

Syndax Pharmaceuticals excels in Q4, poised for growth in 2023

Syndax Pharmaceuticals demonstrated strong financial and developmental performance in Q4 2022, with promising advancements in Revumenib and axatilimab.
While facing challenges in FDA considerations and safety data optimization, Syndax is well-positioned to capitalize on opportunities in expanding market reach and strategic partnerships.
The company's clear financial guidance, enrollment progress, and strategic initiatives underscore a positive outlook for future growth and commercial success.

Syndax Pharmaceuticals reports strong financials and advances key drug candidates

Syndax Pharmaceuticals shows strong financial position with a focus on pivotal drug candidates.
Analyst interest in drug efficacy and trial progress highlights market engagement.
Challenges include financial losses, specific patient response data, and trial design considerations.
Opportunities lie in growth potential, market expansion, and strategic partnerships.

Syndax Pharmaceuticals reports Q2 progress with focus on innovative treatments

Syndax Pharmaceuticals' Q2 performance reflects financial stability with a focus on promising trial outcomes.
Strengths lie in innovative drug development, market reach strategies, and a differentiated treatment approach.
Challenges include regulatory hurdles, commercialization decisions, and managing financial resources effectively.
Opportunities arise from upcoming data releases, market penetration plans, and showcasing treatment differentiators.

Syndax Pharmaceuticals reports positive trial data and financial stability

Syndax Pharmaceuticals showcases strong performance in pivotal trials, supported by a solid financial position and a focus on expanding into new indications.
Challenges include enrollment diversity and breakthrough therapy designation, but opportunities lie in market expansion and personalized treatment approaches.
Overall, Syndax is well-positioned to advance its pipeline and deliver innovative therapies for leukemia patients, with a focus on quality data and strategic growth.

Syndax Pharmaceuticals advances key drugs towards potential approvals and commercialization

Syndax Pharmaceuticals made notable progress in 2023, positioning itself for potential drug approvals and commercialization in 2024.
While facing challenges in market competition and regulatory processes, the company's strategic collaborations and pipeline advancements signal a proactive growth trajectory.
With a strong financial position, ongoing clinical trials, and a focus on refining dosing strategies, Syndax is poised to capitalize on market opportunities and drive innovation in oncology.

Syndax Pharmaceuticals reports strong Q1 performance and readies for transformative year ahead

Syndax Pharmaceuticals showcased strong performance, financial stability, and commercial readiness in their Q1 2024 Earnings Call, highlighting a promising outlook for the company's future.
While facing challenges in patient response rates and market adoption, Syndax's robust pipeline, strategic financial planning, and commercial expertise position it well for growth and success.
With opportunities for retreatment strategies, regulatory expedited pathways, and new market engagements, Syndax is poised for a transformative year ahead, leveraging its strengths to drive innovation and market expansion.

Syndax Pharmaceuticals excels in Q3 with FDA approvals and strategic partnerships

Syndax Pharmaceuticals delivered a strong performance in Q3 2024, marked by FDA approvals and strategic partnerships. Their financial position is robust, setting the stage for successful commercialization and future pipeline advancements. While challenges exist in a competitive landscape, the company's innovative pipeline and market opportunities position them for growth.

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WALTHAM, Mass. , Dec. 19, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the closing of its previously announced underwritten public offering of 12,432,431 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 1,621,621 additional shares.

Syndax Announces Closing of Public Offering of Common Stock and Exercise in Full of the Underwriters' Option to Purchase Additional Shares

WALTHAM, Mass. , Dec. 14, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax" or the "Company") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the pricing of an underwritten public offering of 10,810,810 shares of its common stock.

Syndax Announces Pricing of $200 Million Public Offering of Common Stock

WALTHAM, Mass. , Dec. 14, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax" or the "Company") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it plans to offer and sell, subject to market and other conditions, $150 million of shares of its common stock in an underwritten public offering.

Syndax Announces Proposed $150 Million Public Offering of Common Stock

– Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); CR/CRh rate consistent across adult and pediatric patients – – 63% overall response rate; responses observed across all major subgroups –  – Median overall survival at time of data cutoff of 8.0 months – – Favorable safety and tolerability profile; treatment discontinuations were low at 6% with none due to differentiation syndrome or QTc prolongation – – Supportive results from the AUGMENT-101 trial, including post-transplant maintenance data, continues to demonstrate consistent clinically meaningful responses across subgroups – WALTHAM, Mass. , Dec. 12, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presented positive data from the protocol-defined pooled analysis of the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego, California.

Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting

- Data collectively highlight revumenib's combination potential with current standard of care agents and support advancement into pivotal combination trials in the frontline setting - - 100% CRc observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML - -78% CRc observed in SAVE AML trial, an all-oral combination of revumenib , venetoclax and decitabine/cedazuridine in R/R mNPM1, NUP98r and KMT2Ar AML ; five of nine patients continue in remission, 2 beyond 11 months at the time of the data cut - - 33% CRc observed in AUGMENT-102 trial of revumenib in combination with fludarabine-cytarabine in pediatric R/R mNPM1, NUP98r and KMT2Ar AML - - Revumenib was well tolerated with no new safety signals identified beyond those observed with the respective SOC combinations - WALTHAM, Mass. , Dec. 11, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced data from multiple trials of revumenib in combination with standard of care agents in patients with nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2r) relapsed/refractory (R/R) acute leukemias.

Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials

WALTHAM, Mass. , Dec. 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will host an in-person investor event, along with a live webcast, on Monday, December 11, 2023, at 7:00 a.m.

Syndax to Host Investor Event to Discuss Axatilimab and Revumenib Data Updates at 65th ASH Annual Meeting

WALTHAM, Mass. , Nov. 21, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that data from the pivotal trial of revumenib, the Company's highly selective, oral menin inhibitor, will be featured in a late-breaking presentation at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego, California.

Syndax Announces Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Selected as Late-Breaking Presentation at the 65th ASH Annual Meeting

WALTHAM, Mass. , Nov. 7, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A.

Syndax Announces Participation at Stifel Healthcare Conference

Syndax Pharmaceuticals Inc (SNDX) Q3 2023 Earnings Call Transcript

–  NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under RTOR  – –  mNPM1 final efficacy data from the Phase 1 portion of AUGMENT-101 demonstrates a 36% CR/CRh rate  – –  Revumenib and axatilimab U.S. registrational filings on track for year-end 2023 completion and potential 2024 approvals  – –  Axatilimab to be featured in plenary session at 65th ASH Annual Meeting  – –  Revumenib pivotal monotherapy results, combination with venetoclax and post-transplant maintenance data to be highlighted at 65th ASH Annual Meeting  – –  Company to host conference call today at 4:30 p.m. ET  – WALTHAM, Mass.

Syndax Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update

– Additional data from pivotal AUGMENT-101 trial in R/R KMT2Ar acute leukemia further highlight revumenib's potential best-in-class profile – – 100% ORR (n=7) and manageable safety profile observed in Phase 1 results of SAVE trial, an all-oral combination regimen of revumenib plus venetoclax-decitabine/cedazuridine in R/R AML – – Patients re-started on treatment with revumenib in post-transplant maintenance exhibit durable MRD negative responses – WALTHAM, Mass. , Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that updated data from multiple trials across its clinical program for revumenib, the Company's highly selective, oral menin inhibitor, will be featured in three poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California.

Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting

–  Results support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R monoclonal antibody in chronic graft-versus-host disease  – –  Syndax and Incyte intend to file a Biologics License Application (BLA) by year-end 2023 – WALTHAM, Mass. , Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that results from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (cGVHD), will be featured during the Plenary Scientific Session at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California.

Syndax Announces Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease to Be Featured in Plenary Session at the 65th ASH Annual Meeting

WALTHAM, Mass. , Oct. 26, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its third quarter 2023 financial results and provide a business update on Thursday, November 2, after the close of the U.S. financial markets.

Syndax to Announce Third Quarter 2023 Financial Results and Host Conference Call and Webcast on November 2, 2023

– Solidifies first-to-market potential for revumenib – – High unmet need in relapsed or refractory KMT2Ar patients in the U.S. provides a strong foundation for revumenib commercial launch – WALTHAM, Mass. , Oct. 24, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will submit a New Drug Application (NDA) for revumenib in relapsed or refractory (R/R) KMT2Ar acute leukemia, including acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL), under the U.S. Food and Drug Administration (FDA) Real-Time Oncology Review (RTOR) program.

Syndax to Initiate NDA Submission of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Under FDA's Real-Time Oncology Review Program

Syndax Pharmaceuticals, Inc. reported positive results from its phase 1/2 trial using revumenib to treat relapsed/refractory leukemia patients. The trial met its primary endpoint with a complete remission rate of 23%, significantly higher than the current standard of care. It is expected that an NDA of revumenib for AML is expected before end of 2023; it is also being evaluated in other patient populations which could expand its potential.

Syndax: Biotech To Watch With Regulatory Filings Before End Of 2023

Syndax Pharmaceuticals (NASDAQ:SNDX) Inc (Syndax Pharmaceuticals (NASDAQ:SNDX)) stock was on the back foot on Monday, after reporting results from a leukaemia drug trial which met its primary endpoint. "We are thrilled to report positive results for revumenib in KMT2Ar acute leukaemia that demonstrate the utility of its practice-changing clinical profile and highlight revumenib's potential as a first- and best-in-class agent," chief executive Michael Metzger said.

Syndax Pharmaceuticals fall despite positive leukemia

– Trial met its primary endpoint with a CR/CRh rate of 23% at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); an additional 14% of patients proceeded to transplant without achieving CR/CRh – – 65% (32/49) overall response rate in KMT2Ar AML; CR/CRh rate of 24.5% – – 50% (7/14) of transplanted patients have initiated, and 21% (3/14) of transplanted patients could initiate revumenib as post-transplant maintenance highlighting opportunity for long-term therapy –  – 6.4-month median duration of CR/CRh as of the data cutoff with 46% continuing in remission – – Favorable safety and tolerability profile; only 6% discontinued due to treatment related adverse events – – Syndax poised to submit FDA filings for revumenib and axatilimab by the end of 2023 – – Syndax to host a conference call today at 8:00 a.m. ET  – WALTHAM, Mass.

Syndax Announces Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Meets Primary Endpoint and Stopped Early for Efficacy Following Protocol-Defined Interim Analysis

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Syndax Pharmaceuticals Inc. SNDX, -7.10% rose 19% in premarket trading. The clinical stage biopharmaceutical company said late Friday that it would release topline results from its trial of Revumenib to treat certain forms of leukemia.

SmileDirectClub shares plunge after bankruptcy filing, with Syndax and AMC shares climbing and other active stocks

WALTHAM, Mass. , Sept. 29, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will host a conference call and live webcast to share topline results from the pivotal AUGMENT-101 trial in patients with relapsed/refractory KMT2Ar acute leukemia on Monday, October 2, 2023 at 8:00 a.m.

Syndax to Announce Topline Results from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia and Host an Investor Call on October 2, 2023

Syndax is making strides in the adoption of entinostat, a cancer therapeutic used in combination with immune checkpoint therapies. Syndax reported an increase in operating expenses in Q2 2023, but remains financially stable with cash reserves of $418.3 million. Syndax has two leading candidates in its drug pipeline, revumenib and axatilimab, which show promise in treating acute leukemia and chronic graft-versus-host disease (cGVHD) respectively.

Syndax Pharmaceuticals: Positive Axatilimab Phase 2 Results

WALTHAM, Mass. , Aug. 31, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A.

Syndax Announces Participation at the Citi 18th Annual BioPharma Conference

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Sharon Klahre - Head, IR Michael Metzger - CEO Neil Gallagher - President & Head, R&D Keith Goldan - CFO Peter Ordentlich - CSO Anjali Ganguli - CBO Conference Call Participants Phil Nadeau - TD Cowen Anupam Rama - JPMorgan Ashiq Mubarack - Citi Brad Canino - Stifel Michael Schmidt - Guggenheim Peter Lawson - Barclays William Wood - B. Riley Securities Justin Zelin - BTIG Operator Good day, everyone, and welcome to the Syndax Second Quarter 2023 Earnings Conference Call.

Syndax Pharmaceuticals, Inc. (SNDX) Q2 2023 Earnings Call Transcript

– Announced positive topline results from the pivotal AGAVE-201 trial of axatilimab in cGVHD – – Topline data from the pivotal AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia on track for the third quarter of 2023 – – Two U.S. registrational filings expected by the end of 2023 – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

WALTHAM, Mass. , July 25, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its second quarter 2023 financial results and provide a business update on Thursday, August 3, after the close of the U.S. financial markets.

Syndax to Announce Second Quarter 2023 Financial Results and Host Conference Call and Webcast on August 3, 2023

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– Trial met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks – –  Data highlight durable response to treatment. At the 0.3 mg/kg dose, 60% of patients who responded to axatilimab were still responding at one year – –  Results continue to support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R monoclonal antibody in chronic graft-versus-host disease (GVHD) – – Syndax and Incyte intend to file a Biologics License Application (BLA) by year-end 2023; full dataset to be presented at a future medical meeting – – Syndax to host conference call today at 8:30 a.m.

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