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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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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- Data continue to support revumenib's potential to enhance current standard of care agents - - 96% CRc (23 of 24 pts) observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML - - 52% CRc (14 of 27 pts) observed in AUGMENT-102 trial of revumenib in combination with fludarabine-cytarabine in acute leukemia patients with R/R mNPM1, NUP98r or KMT2Ar - WALTHAM, Mass. , June 14, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated data from multiple combination trials of revumenib, the Company's potent, selective, small molecule menin inhibitor, in patients with acute leukemias.

Syndax Presents Updated Positive Data from BEAT AML and AUGMENT-102 Phase 1/2 Combination Trials of Revumenib in Patients with Acute Leukemias at EHA 2024 Congress

– IDMC recommendation to advance based on favorable safety profile observed in Phase 1a portion of trial – WALTHAM, Mass. , June 6, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it has advanced into the Phase 1b portion of its Phase 1/2 proof-of-concept trial of revumenib, the Company's highly selective, oral menin inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) metastatic microsatellite stable (MSS) colorectal cancer (CRC).

Syndax Announces Plans to Advance into Phase 1b Portion of Trial Evaluating Revumenib in Relapsed or Refractory Metastatic MSS CRC

WALTHAM, Mass. , June 5, 2024 /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 Goldman Sachs 45th Annual Global Healthcare Conference

WALTHAM, Mass. , May 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Aleksandra Rizo, M.D.

Syndax Pharmaceuticals Appoints Aleksandra Rizo, M.D., Ph.D. to the Board of Directors

WALTHAM, Mass. , May 9, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that members of the Syndax management team will participate in a fireside chat at the Bank of America Securities 2024 Health Care Conference on Thursday, May 16, 2024, at 8:00 a.m.

Syndax Announces Participation at the Bank of America Securities 2024 Health Care Conference

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - CEO & Director Steve Closter - Chief Commercial Officer Keith Goldan - CFO Neil Gallagher - President, Head of Research and Development Anjali Ganguli - Chief Business Officer Conference Call Participants Peter Lawson - Barclays Capital Anupam Rama - JPMorgan Securities Brad Canino - Stifel, Nicolaus & Company Phil Nadeau - Cowen & Co. Michael Schmidt - Guggenheim Securities Yigal Nochomovitz - Citigroup Kalpit Patel - B. Riley Securities Jason Zemansky - Bank of America Merrill Lynch Justin Zelin - BTIG Chris Shibutani - Goldman Sachs & Co. George Farmer - Scotia Capital Operator Good day, everyone, and welcome to the Syndax First Quarter 2024 Earnings Conference Call.

Syndax Pharmaceuticals, Inc. (SNDX) Q1 2024 Earnings Call Transcript

– NDA filing for revumenib in R/R KMT2Ar acute leukemia granted Priority Review under RTOR; PDUFA action date set for September 26, 2024 – – BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – Enrollment completed in AUGMENT-101 mNPM1 cohort; topline data expected in 4Q24 to potentially support sNDA filing in 1H25 – – Company to host conference call today at 8:00 a.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update

WALTHAM, Mass. , May 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its first quarter 2024 financial results and provide a business update on Wednesday, May 8, 2024.

Syndax to Announce First Quarter 2024 Financial Results and Host Conference Call and Webcast on May 8, 2024

WALTHAM, Mass. , April 10, 2024 /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 Stifel 2024 Virtual Targeted Oncology Forum

– Consistent safety and efficacy profiles across adult and pediatric populations – – Majority of pediatric patients who achieved an overall response proceeded to transplant; patients receiving post-transplant revumenib maintenance remained in remission as of data cutoff date – – No treatment-related discontinuations or dose reductions – WALTHAM, Mass. , April 8, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the presentation of positive data from the pivotal AUGMENT-101 trial in pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) treated with revumenib, a first-in-class menin inhibitor.

Syndax Presents Positive Pediatric Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary Session

Syndax Pharmaceuticals (SNDX) groundbreaking menin inhibitor, revumenib, receives FDA priority review for treating relapsed, refractory acute leukemia.

Syndax (SNDX) Gets FDA Priority Tag for Leukemia Drug NDA

– Topline data expected in 4Q24 could support sNDA filing in 1H25 – – Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity – WALTHAM, Mass. , March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML).

Syndax Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia

– PDUFA action date set for September 26, 2024 – – NDA being reviewed under FDA's RTOR program – WALTHAM, Mass., March 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for revumenib, the Company's first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia.

Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia

– Steven Closter brings more than 30 years of commercial experience in the biopharmaceutical industry to Syndax – – Company on track for two potential first- and best-in-class product launches in 2024 – WALTHAM, Mass., March 18, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Steven Closter as Chief Commercial Officer, effective immediately.

Syndax Announces Appointment of Steven Closter as Chief Commercial Officer

Syndax Pharmaceuticals, Inc. (SNDX) Q4 2023 Earnings Call Transcript

– BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – NDA for revumenib in R/R KMT2Ar acute leukemia submitted under FDA's RTOR program; PDUFA date assignment expected in 1Q24 – – Enrollment in AUGMENT-101 mNPM1 patient cohort expected to complete in late 1Q/early 2Q; topline data in 4Q24 – – Initiated revumenib Phase 1 combination trial with 7+3 chemotherapy in newly diagnosed acute leukemias – – Axatilimab Phase 2 IPF trial underway – – $600 million in cash and cash equivalents expected to provide runway through 2026 – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update

Syndax (SNDX) could be a solid choice for shorter-term investors looking to capitalize on the recent price trend in fundamentally sound stocks. It is one of the many stocks that passed through our shorter-term trading strategy-based screen.

Syndax (SNDX) is on the Move, Here's Why the Trend Could be Sustainable

WALTHAM, Mass. , Feb. 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that members of its management team will participate in the following sessions at two upcoming investor conferences: A fireside chat at TD Cowen's 44th Annual Health Care Conference at 9:50 a.m.

Syndax Announces Participation at Two Upcoming Investor Conferences

WALTHAM, Mass. , Feb. 20, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its fourth quarter and year-end 2023 financial results and provide a business update on Tuesday, February 27, after the close of the U.S. financial markets.

Syndax to Announce Fourth Quarter and Year-end 2023 Financial Results and Host Conference Call and Webcast on February 27, 2024

WALTHAM, Mass. , Jan. 2, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A.

Syndax Announces Presentation at 42nd Annual J.P. Morgan Healthcare Conference

– BLA submitted for axatilimab in chronic graft-versus-host disease; Syndax exercised option to co-commercialize axatilimab in the U.S. with Incyte – – NDA submitted for revumenib in R/R KMT2Ar acute leukemia under U.S. FDA's RTOR program – – Completion of enrollment in AUGMENT-101 mNPM1 patient cohort expected in  late 1Q/early 2Q with topline data anticipated in 4Q24 – – Completion of $230 million follow-on offering in December extends runway through 2026  – WALTHAM, Mass. , Jan. 2, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today highlighted recent updates and anticipated 2024 milestones.

Syndax Highlights Recent Updates and Anticipated 2024 Milestones

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

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