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Syndax Highlights Recent Accomplishments and Anticipated 2025 Milestones at the 43rd Annual J.P. Morgan Healthcare Conference
Prnewswire· 2025-01-13 12:00
Company Achievements - Launched Revuforj® (revumenib), the first and only FDA-approved menin inhibitor, for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older [2][6] - Revumenib was added to the NCCN Clinical Practice Guidelines for AML and ALL as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement [2][6] - Received FDA approval for Niktimvo™ (axatilimab-csfr) for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg [2][10] - Announced a $350 million royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo, which is expected to help the company reach profitability [7] Clinical Trial Results - Met the primary endpoint in the Phase 2 cohort of the AUGMENT-101 trial of revumenib in 64 adults with R/R mNPM1 AML [6] - Reported an overall response rate (ORR) of 100% and a composite complete remission (CRc) rate of 95% in the BEAT AML trial evaluating revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients [6] - Presented an ORR of 82% and a CR/CRh rate of 48% in the SAVE trial evaluating revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with R/R AML or MPAL [6] - Published results from the pivotal Phase 2 AGAVE-201 trial of axatilimab in adult and pediatric patients with recurrent/refractory active chronic GVHD in the New England Journal of Medicine [10] 2025 Milestones - Submit a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025, with potential FDA approval around year-end 2025 [11] - Initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients unfit to receive intensive chemotherapy in Q1 2025 [11] - Launch Niktimvo in the U.S. in early Q1 2025, co-commercialized by Syndax and Incyte [11] - Complete enrollment in the MAXPIRe Phase 2 IPF trial in 2025, with topline data expected in 2026 [11] Industry Impact - Revumenib and axatilimab are positioned to address multi-billion-dollar markets, with potential for expansion into additional indications [3] - The company's robust clinical data and first-mover advantage with Revuforj are expected to drive U.S. adoption as the preferred menin inhibitor [11] - Syndax's strong cash position, including the $350 million royalty funding agreement, is expected to fund operations through profitability [7]
Kuehn Law Encourages Investors of Syndax Pharmaceuticals, Inc. to Contact Law Firm
Prnewswire· 2025-01-08 02:20
Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Syndax Pharmaceuticals, Inc. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - Kuehn Law is a shareholder litigation law firm conducting an investigation into Syndax Pharmaceuticals, Inc. for possible self-dealing by its officers and directors [1]. - The investigation may lead to shareholders being entitled to damages and reforms in corporate governance [1]. - Long-term shareholders of Syndax Pharmaceuticals are encouraged to contact Kuehn Law for a free consultation regarding their rights [2]. Group 2 - The firm emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets [3]. - Kuehn Law offers to cover all case costs and does not charge its investor clients, highlighting a no-obligation consultation [2]. - The firm encourages immediate contact from shareholders due to potential time limitations in enforcing their rights [2].
SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Is Investigating Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) for Potential Breaches of Fiduciary Duty By Its Board of Directors
Prnewswire· 2024-12-19 15:37
Group 1 - Purcell & Lefkowitz LLP is investigating a potential breach of fiduciary duty claim involving the board of directors of Syndax Pharmaceuticals, Inc. [1] - The law firm is dedicated to representing shareholders nationwide who are victims of securities fraud and corporate misconduct [2] - Shareholders of Syndax Pharmaceuticals, Inc. can obtain additional information regarding the investigation free of charge [1]
Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib
Prnewswire· 2024-11-12 12:00
–      Primary endpoint met with CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R mNPM1 AML patients (p-value = 0.0014) ––      47% (30/64) ORR in a heavily pre-treated population, including 75% with prior venetoclax exposure in the efficacy population ––      Favorable safety and tolerability profile; only 5% of patients discontinued due to treatment-related adverse events ––      Results highlight consistency of revumenib's compelling clinical profile ––      sNDA filing in R/R mNPM1 AML expected in 1H25, ...
Syndax(SNDX) - 2024 Q3 - Earnings Call Transcript
2024-11-06 01:39
Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q3 2024 Earnings Conference Call November 5, 2024 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Neil Gallagher - President & Head, R&D Steve Closter - Chief Commercial Officer Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Strategy Officer Conference Call Participants Priyanka Grover - JPMorgan Brad Canino - Stifel Peter Lawson - Barclays Chris Shibutani - Goldman Sachs Kelly Shi - ...
Syndax(SNDX) - 2024 Q3 - Earnings Call Presentation
2024-11-05 23:14
| --- | --- | --- | --- | |-------------------------------------|-------|-------|-----------------------------------------------------------------| | | | | | | | | | | | Syndax Reimagining Cancer Treatment | | | | | | | | Third Quarter Financial Results Presentation / November 5, 2024 | Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipa ...
Syndax Pharmaceuticals (SNDX) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-05 23:10
Syndax Pharmaceuticals (SNDX) came out with a quarterly loss of $0.98 per share versus the Zacks Consensus Estimate of a loss of $1.13. This compares to loss of $0.73 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 13.27%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.91 per share when it actually produced a loss of $0.80, delivering a surprise of 12.09%.Over the last four quarters, ...
Syndax(SNDX) - 2024 Q3 - Quarterly Report
2024-11-05 21:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37708 Syndax Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 32-0162505 (State or Oth ...
Syndax(SNDX) - 2024 Q3 - Quarterly Results
2024-11-05 21:02
Exhibit 99.1 Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update – New revumenib and Niktimvo™clinical data will be highlighted at 66 th ASH Annual Meeting – – mNPM1 AML topline data from AUGMENT-101 expected in 4Q24; potential sNDA filing in 1H25 – – Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 – – Niktimvo approved by U.S. FDA for treatment of chronic GVHD after failure of at least two prior lines of systemic t ...
Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update
Prnewswire· 2024-11-05 21:01
–  New revumenib and Niktimvo™ clinical data will be highlighted at 66th ASH Annual Meeting –– mNPM1 AML topline data from AUGMENT-101 expected in 4Q24; potential sNDA filing in 1H25 –– Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 –– Niktimvo approved by U.S. FDA for treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg ––  $350 million royalty funding ...