Syndax Pharmaceuticals Discloses Updated Data From Multiple Combination Trials Of revumenib, The Company's Potent Small Molecule Menin Inhibitor, In Patients With Acute Leukemias

6/14/24 7:09:01 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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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 -

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Recent Analyst Ratings for
$SNDX

Date	Price Target	Rating	Analyst
10/24/2024	$37.00	Buy	UBS
6/28/2024	$37.00	Buy	Jefferies
1/31/2024	$36.00 → $23.00	Sector Outperform → Sector Perform	Scotiabank
12/22/2023	$45.00	Buy	Mizuho
10/25/2023	$29.00	Buy	BofA Securities
10/11/2023	$30.00	Buy	Goldman
7/27/2023		Sector Outperform	Scotiabank
7/11/2023	$40.00	Buy	Guggenheim

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$SNDX
Press Releases

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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
– 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., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therap
11/15/24 5:29:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Nov. 14, 2024 /PRNewswire/ -- USA News Group News Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American Medical Association is pointing out the alarming trend of rising cancer rates, especially with younger people. According to data released from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), a map shared by Newsweek showed that the prevalence of cancer varies significantly from state to state. Thankfully, there are plenty of new breakthroughs in the fight against cancer that the World Eco
11/14/24 8:00:00 AM ET
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Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib
– 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 /PRNew
11/12/24 7:00:00 AM ET
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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
– 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., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therap
11/15/24 5:29:00 PM ET
$SNDX
Biotechnology: Pharmaceutical Preparations
Health Care
Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib
– 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 /PRNew
11/12/24 7:00:00 AM ET
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Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update
– 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., Nov. 5, 2024 /PRNewswire/ -- Syndax
11/5/24 4:01:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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Pyxis Oncology Expands Board of Directors with Appointment of Michael A. Metzger
BOSTON, June 10, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: "PYXS"), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today announced the appointment of Michael A. Metzger to its Board of Directors, effective June 10, 2024. Mr. Metzger has over 25 years of experience in the biopharmaceutical sector, currently serving as Chief Executive Officer and as a member of the Board of Directors of Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) since 2015. "We are delighted to have Michael, a proven leader in our industry with a robust track record of success, join the board," said Lara S. Sullivan, M.D., President and Chief Ex
6/10/24 7:30:00 AM ET
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Syndax Pharmaceuticals Appoints Aleksandra Rizo, M.D., Ph.D. to the Board of Directors
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., Ph.D., to its Board of Directors. Dr. Rizo has extensive clinical development experience and a track record of successfully leading the development of several hematology drugs from discovery through commercialization. She will serve as a member of the Science and Technology Committee of the Board. Dr. Rizo will replace Dr. Briggs Morrison who will step down effective May 14, 2024 after a successful 9-year tenure as a member of the Company's Board of Directo
5/15/24 4:05:00 PM ET
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Zymeworks Announces Appointment of Dr. Neil Gallagher to its Board of Directors
VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced the appointment of Dr. Neil Gallagher to its board of directors effective April 2, 2024. "Dr. Gallagher is the sixth director to join our board of directors in the past twelve months as we continue to refresh and strengthen the Board governance and oversight required for the next stage of the Company's development and growth," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "His exp
3/28/24 6:00:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Syndax Pharmaceuticals Discloses Updated Data From Multiple Combination Trials Of revumenib, The Company's Potent Small Molecule Menin Inhibitor, In Patients With Acute Leukemias

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Recent Analyst Ratings for $SNDX

$SNDX Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

Chief Financial Officer Goldan Keith A. bought $25,037 worth of shares (1,250 units at $20.03), increasing direct ownership by 2% to 52,623 units (SEC Form 4)

SEC Form 4 filed by Rizo Aleksandra

SEC Form 3 filed by new insider Rizo Aleksandra

$SNDX Press Releases

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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

Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon

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

$SNDX Financials

Live finance-specific insights

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

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

Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update

$SNDX Analyst Ratings

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UBS initiated coverage on Syndax Pharmaceuticals with a new price target

Jefferies initiated coverage on Syndax Pharmaceuticals with a new price target

Syndax Pharmaceuticals downgraded by Scotiabank with a new price target

$SNDX Market Insights

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Jefferies Initiates Coverage On Syndax Pharmaceuticals with Buy Rating, Announces Price Target of $37

Stifel Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $42

HC Wainwright & Co. Reiterates Buy on Syndax Pharmaceuticals, Maintains $41 Price Target

$SNDX SEC Filings

Syndax Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

SEC Form 10-Q filed by Syndax Pharmaceuticals Inc.

Syndax Pharmaceuticals Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

$SNDX Large Ownership Changes

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Amendment: SEC Form SC 13G/A filed by Syndax Pharmaceuticals Inc.

Amendment: SEC Form SC 13G/A filed by Syndax Pharmaceuticals Inc.

SEC Form SC 13G filed by Syndax Pharmaceuticals Inc.

$SNDX Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

Chief Financial Officer Goldan Keith A. bought $25,037 worth of shares (1,250 units at $20.03), increasing direct ownership by 2% to 52,623 units (SEC Form 4)

$SNDX FDA approvals

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FDA Approval for REVUFORJ issued to SYNDAX PHARMACEUTICALS INC

$SNDX Leadership Updates

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Pyxis Oncology Expands Board of Directors with Appointment of Michael A. Metzger

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

Zymeworks Announces Appointment of Dr. Neil Gallagher to its Board of Directors

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