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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WALTHAM, Mass. , Dec. 6, 2022 /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 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

The FDA bestows a Breakthrough Therapy designation to Syndax's (SNDX) revumenib for treating patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement. Stock up.

Syndax's (SNDX) Leukemia Drug Gets FDA Breakthrough Therapy Tag

-- Revumenib is the first and only investigational treatment for R/R KMT2Ar acute leukemia to receive Breakthrough Therapy Designation -- -- Designation is based on Phase 1 data from the AUGMENT-101 trial that showed a 27% CR/CRh rate in KMT2A patients treated at RP2D -- -- Company remains on track to submit an NDA for revumenib by the end of 2023 with the potential for an expedited approval with a broad indication -- WALTHAM, Mass. , Dec. 5, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (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 Breakthrough Therapy Designation (BTD) for revumenib for the treatment of adult and pediatric patients with relapsed or refractory (R/R) acute leukemia harboring a KMT2A rearrangement (KMT2Ar).

Syndax Announces U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory KMT2A- Rearranged (MLLr) Acute Leukemia

Incyte

– Treatment with axatilimab resulted in an overall response rate (ORR) of 67% across all patients; and an ORR of 82% in patients dosed at 1 mg/kg every 2 weeks in the Phase 2 portion of the trial – – Broad multi-organ clinical benefit including in lung, skin, and joints and fascia observed in heavily pretreated patient population – WALTHAM, Mass. and WILMINGTON, Del.

Syndax Pharmaceuticals and Incyte Announce Axatilimab Phase 1/2 Data in Patients with Chronic Graft-Versus-Host Disease Published in the Journal of Clinical Oncology

Syndax (SNDX) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.

What Makes Syndax (SNDX) a Good Fit for 'Trend Investing'

WALTHAM, Mass. , Dec. 2, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Steve Sabus to the role of Chief Commercial Officer, effective December 5, 2022.

Syndax Pharmaceuticals Announces Appointment of Steve Sabus as Chief Commercial Officer

The consensus price target hints at a 39.1% 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.

Can Syndax (SNDX) Climb 39% to Reach the Level Wall Street Analysts Expect?

WALTHAM, Mass. , Nov. 21, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (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 a fireside chat at the Evercore ISI Annual HealthCONx Conference on Wednesday, November 30, 2022, at 3:30 p.m.

Syndax Announces Participation at Evercore ISI Annual HealthCONx Conference

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Briggs Morrison - President and Head, R&D Keith Goldan - Chief Financial Officer Conference Call Participants Philip Nadeau - Cowen Kalpit Patel - B Riley Securities Madhu Kumar - Goldman Sachs Ashiq Mubarack - Citi Peter Lawson - Barclays Joel Beatty - Baird Operator Good day, everyone and welcome to the Syndax Third Quarter 2022 Earnings Conference Call. Today's call is being recorded.

Syndax Pharmaceuticals, Inc. (SNDX) Q3 2022 Earnings Call Transcript

– Updated positive data from Phase 1 portion of AUGMENT-101 trial demonstrates CR/CRh rate of 30% and a median durability of response of 9.1 months – – Enrollment complete in pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD – – Company remains on track for two U.S. registrational filings by the end of 2023 – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update

- 30% CR/CRh rate and 53% ORR in R/R acute leukemia patients with NPM1 or MLLr (KMT2Ar) mutations; no discontinuations due to treatment-related adverse events - -  Median duration of CR/CRh response of 9.1 months - -  9 of 12 patients who underwent stem cell transplant after achieving a response with revumenib remained in remission, with 4 continuing beyond one year - - Data will be featured in two oral presentations at the 64th ASH Annual Meeting - - Company to host conference call and webcast on Sunday, December 11, 2022 at 8:00 a.m. CT/ 9:00 a.m.

Syndax Announces Positive Updates to Clinical Activity and Durable Remissions in Phase 1 Portion of AUGMENT-101 Trial of Revumenib in Patients with Acute Leukemias

WALTHAM, Mass. , Oct. 27, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its third quarter 2022 financial results and provide a business update on Thursday, November 3, after the close of the U.S. financial markets.

Syndax to Announce Third Quarter 2022 Financial Results and Host Conference Call and Webcast on November 3, 2022

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Briggs Morrison - President and Head, R&D Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Business Officer Conference Call Participants Phil Nadeau - Cowen & Company Kalpit Patel - B. Riley Securities Ashiq Mubarack - Citi Joel Beatty - Baird Peter Lawson - Barclays Operator Good day everyone and welcome to the Syndax Second Quarter 2022 Earnings Conference Call.

Syndax Pharmaceuticals, Inc. (SNDX) CEO Michael Metzger on Q2 2022 Results - Earnings Call Transcript

Amphastar Pharma

Amphastar and Syndax, two top-rated biotech stocks, topped second-quarter estimates on Tuesday. But shares stayed flat.

Amphastar, Syndax Top Second-Quarter Estimates, But Runaway Biotechs At A Standstill

– On track to report topline data from revumenib and axatilimab pivotal programs starting in 1H23 – – Updated data from Phase 1 portion of AUGMENT-101 trial expected in 4Q22 – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Clinical and Business Update

WALTHAM, Mass. , Aug. 2, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its second quarter 2022 financial results on Monday, August 8, after the close of the U.S. financial markets.

Syndax to Announce Second Quarter 2022 Financial Results and Host Conference Call and Webcast on August 8, 2022

The average of price targets set by Wall Street analysts indicates a potential upside of 66.9% 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.

Does Syndax (SNDX) Have the Potential to Rally 67% as Wall Street Analysts Expect?

WALTHAM, Mass. , June 13, 2022 /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 appointment of Keith A.

Syndax Pharmaceuticals Announces Appointment of Keith A. Goldan as Chief Financial Officer

WALTHAM, Mass. , May 11, 2022 /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 that Michael A.

Syndax Announces Participation at Citi's Biopharma Virtual Co-Panel Day

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q1 2022 Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants Maghan Meyers - Vice President, Argot Partners Michael Metzger - Chief Executive Officer Briggs Morrison - President & Head, R&D Alex Nolte - Chief Accounting Officer Peter Ordentlich - Chief Scientific Officer Conference Call Participants Madhu Kumar - Goldman Sachs Phil Nadeau - Cowen & Company Bert Hazlett - BTIG Ashiq Mubarack - Citigroup Joel Beaty - Baird Peter Lawson - Barclays Operator Good day and welcome to the Syndax First Quarter 2022 Earnings Conference Call. Today's call is being recorded.

Syndax Pharmaceuticals, Inc. (SNDX) CEO Michael Metzger on Q1 2022 Results - Earnings Call Transcript

Syndax (SNDX) delivered earnings and revenue surprises of 0% and 100%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Syndax Pharmaceuticals (SNDX) Reports Q1 Loss, Lags Revenue Estimates

– Topline data from revumenib (SNDX-5613) and axatilimab pivotal programs expected starting in 1H23; Company remains on track for two FDA filings in 2023 – – BEAT-AML and AUGMENT-102 trials assessing revumenib (SNDX-5613) in combination with venetoclax-azacitidine for newly diagnosed patients and in combination with chemotherapy for R/R patients both underway; topline data expected starting in 1H23 – – Axatilimab granted Fast Track by U.S. FDA for the treatment of cGVHD after failure of two or more lines of systemic therapy – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass.

Syndax Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Clinical and Business Update

WALTHAM, Mass. , May 2, 2022 /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 that it will release its first quarter 2022 financial results on Monday, May 9, after the close of the U.S. financial markets.

Syndax to Announce First Quarter 2022 Financial Results and Host Conference Call and Webcast on May 9, 2022

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Today's $19 share quote is backed by as much as $7.50 in cash vs. total liabilities under $1 per unit. Larger drug trials are underway testing the usefulness of two cancer-related products.

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