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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The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and pediatric patients with a type of blood cancer, sending the company's shares up 3% in after-hours trading.

US FDA approves Syndax's blood cancer drug

– Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation – – Syndax to host conference call today at 6:00 p.m. ET – WALTHAM, Mass.

Syndax Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

Primary endpoint of pivotal phase 2 study met with statistical significance in using Revumenib for the treatment of relapsed/refractory mNPM1 AML patients; sNDA expected 1st half 2025. PDUFA action date of December 26th of 2024 deployed for FDA to decide if Revumenib should be approved for the treatment of relapsed/refractory KMT2Ar Acute leukemia patients. The global acute myeloid leukemia market is expected to reach $5.86 billion by 2030; About 10% of patients have KMT2Ar AML and then 30% have mNPM1 AML.

Syndax: Fall On NPM1m AML Data Of Revumenib Creates Buy Opportunity

–      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, pending anticipated FDA approval of revumenib in R/R KMT2Ar acute leukemia in 4Q24 – –      Syndax to host a conference call today at 8:00 am ET – WALTHAM, Mass. , Nov. 12, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced positive topline results from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, an oral, small molecule menin inhibitor.

Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib

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 - Jefferies Phil Nadeau - TD Cowen Michael Schmidt - Guggenheim Ashiq Mubarack - Citi Jason Zemansky - Bank of America George Farmer - Scotiabank Kalpit Patel - B. Riley Securities Justin Zelin - BTIG Operator Good day, everyone, and welcome to the Syndax Third Quarter 2024 Earnings Conference Call.

Syndax Pharmaceuticals, Inc. (SNDX) Q3 2024 Earnings Call Transcript

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.

Syndax Pharmaceuticals (SNDX) Reports Q3 Loss, Tops Revenue Estimates

–  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 agreement for Niktimvo  expected to fund Company through profitability – – Company to host a conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update

WALTHAM, Mass. , Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-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 9, 2024, at 7:00 a.m.

Syndax to Host ASH Investor Event in Person and via Webcast on December 9, 2024

– New monotherapy and combination data in acute leukemia further highlight revumenib's compelling clinical profile –  – 64% ORR (62/97) in expanded dataset of patients with R/R KMT2Ar acute leukemia in Ph 2 AUGMENT-101 pivotal cohort – –  88% ORR (23/26) in SAVE trial testing revumenib, venetoclax and decitabine/cedazuridine combination in R/R AML – WALTHAM, Mass. , Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that multiple abstracts evaluating revumenib, an oral small molecule menin inhibitor, have been accepted for oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, California, December 7-10, 2024.

Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting

– Rapid responses and symptom improvement observed in inflammatory and fibrotic manifestations of chronic GVHD in heavily pretreated patients – WALTHAM, Mass. , Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq:SNDX), today announced that multiple abstracts evaluating Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody for the treatment of chronic graft-versus-host disease (GVHD), have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, California, December 7-10, 2024.

Syndax Announces New Data from Secondary Analysis of the Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease to Be Presented at 66th ASH Annual Meeting

Royalty Pharma

Proceeds expected to support the upcoming planned launches and fund the continued development of Niktimvo and revumenib Expected to fund Company through profitability; proforma cash approaching $800 million as of June 30 WALTHAM, Mass. and NEW YORK , Nov. 4, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) and Royalty Pharma plc (Nasdaq: RPRX) today announced that Syndax has entered into a $350 million synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo™ (axatilimab-csfr).

Syndax Pharmaceuticals and Royalty Pharma Enter into $350 Million Royalty Funding Agreement for Niktimvo™

WALTHAM, Mass. , Nov. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on November 1, 2024 the Company granted inducement awards to purchase up to 78,700 shares of common stock to four new employees under the Company's 2023 Inducement Plan.

Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

WALTHAM, Mass. , Nov. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A.

Syndax Announces Participation in November Investor Conferences

WALTHAM, Mass. , Oct. 29, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its third quarter 2024 financial results and provide a business update on Tuesday, November 5, 2024.

Syndax to Announce Third Quarter 2024 Financial Results and Host Conference Call and Webcast on November 5, 2024

Incyte

– Trial met its primary endpoint across all dose cohorts with 74% of patients at the 0.3 mg/kg every 2 weeks dose achieving a complete or partial response within the first six months of treatment – – Niktimvo approved by U.S. FDA for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg – – Niktimvo added to latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of chronic GVHD – WILMINGTON, Del. and WALTHAM, Mass.

Incyte and Syndax Announce New England Journal of Medicine Publication of Data from Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease

BOSTON--(BUSINESS WIRE)--Foundation Medicine partners with Syndax to develop a companion diagnostic to identify acute myeloid leukemia patients harboring an NPM1 mutation.

Foundation Medicine Partners with Syndax to Develop a Companion Diagnostic in Hematology and Support Efforts to Pursue Regulatory Approval for an Assay Based on the FoundationOne®Heme Platform

– Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of patients with KMT2Ar AML and ALL (p-value = 0.0036) – – NDA filing for revumenib in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 – WALTHAM, Mass. , Aug. 12, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that data from the pivotal Phase 2 portion of the 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) have been published in the Journal of Clinical Oncology.

Syndax Announces Publication in the Journal of Clinical Oncology of Data from the Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia

Syndax Pharmaceuticals, Inc. (SNDX) Q2 2024 Earnings Call Transcript

–  Axatilimab BLA in refractory chronic GVHD is under Priority Review; PDUFA action date of August 28, 2024 – – Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 – – Pivotal AUGMENT-101 topline data from the mNPM1 AML cohort expected in 4Q24; potential sNDA filing in 1H25 – – Company to host a conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Reports Second Quarter 2024 Financial Results and Provides Clinical and Business Update

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Shares of Syndax Pharmaceuticals (SNDX) plunged in intraday trading Monday after the biopharmaceutical company reported that the Food and Drug Administration (FDA) delayed a decision on approving its experimental treatment for acute leukemia.

FDA Delays Decision on Syndax Leukemia Drug; Stock Sinks

– New PDUFA action date of December 26, 2024 allows FDA additional time to complete their review –  WALTHAM, Mass. , July 29, 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 extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for revumenib for the treatment of adults and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia.

Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia

The consensus price target hints at a 50.3% upside potential for Syndax (SNDX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Think Syndax (SNDX) Could Surge 50.26%: Read This Before Placing a Bet

WALTHAM, Mass. , July 25, 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 second quarter 2024 financial results and provide a business update on Thursday, August 1, 2024.

Syndax to Announce Second Quarter 2024 Financial Results and Host Conference Call and Webcast on August 1, 2024

The average of price targets set by Wall Street analysts indicates a potential upside of 67.1% in Syndax (SNDX). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

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