Submission status for SYNDAX PHARMACEUTICALS INC's drug REVUFORJ (ORIG-1) with active ingredient REVUMENIB has changed to 'Approval' on 11/15/2024. Application Category: NDA, Application Number: 218944, Application Classification: Type 1 - New Molecular Entity

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

3 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

4 - Syndax Pharmaceuticals Inc (0001395937) (Issuer)

– 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

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

–      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

–  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

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. PT/10:00 a.m. ET during the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, California. Members of the Syndax management team will be joined by multiple key opinion leaders to discuss data updates from the Company's revumenib and Niktimvo™ (axatilimab-csfr) programs. A live webcast of the event will be available on the Investor section of the Company

– 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.

– 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. The presentations will highlight a secondary analysis of overall and organ-specific responses and findings from an exposure-response analysis in pat

Proceeds expected to support the upcoming planned launches and fund the continued development of Niktimvo and revumenibExpected to fund Syndax through profitability; proforma cash approaching $800 million as of June 30 NEW YORK and WALTHAM, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) and Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that Royalty Pharma has entered into a $350 million synthetic royalty funding agreement with Syndax based on U.S. net sales of Niktimvo (axatilimab-csfr). "We are excited to partner with Syndax, an innovative oncology company with an exciting pipeline" said Pablo Legorreta, founder and CEO of Royalty Pharma. "Niktimvo

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).  "We expect this transaction to fund us through profitability, while ensuring that we continue to participate in the profits from Niktimvo and retain the upside of its future

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. The stock options will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date and 1/48th of the underlying shares vesting monthly thereafter over 36 months, subject to the employee's continued service relationship with Syndax through the applicable vesting

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8-K - Syndax Pharmaceuticals Inc (0001395937) (Filer)

8-K - Syndax Pharmaceuticals Inc (0001395937) (Filer)

10-Q - Syndax Pharmaceuticals Inc (0001395937) (Filer)

8-K - Syndax Pharmaceuticals Inc (0001395937) (Filer)

8-K - Syndax Pharmaceuticals Inc (0001395937) (Filer)

10-Q - Syndax Pharmaceuticals Inc (0001395937) (Filer)

8-K - Syndax Pharmaceuticals Inc (0001395937) (Filer)

ARS - Syndax Pharmaceuticals Inc (0001395937) (Filer)

– 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

–      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

–  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

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. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, November 5, 2024 to discuss the Company's financial results and provide a business update. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's we

Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD Pivotal data from the AGAVE-201 study supporting the approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups Syndax conference call and webcast scheduled for today at 6:00 p.m. ET Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (NASDAQ:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of syste

–  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., Aug. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended June 30, 2024, and provided a business update. "This is an exc

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. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, August 1, 2024 to discuss the Company's financial results and provide a business update. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's websi

– 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., May 8, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended March 31, 2024, and prov

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. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 8:00 a.m. ET on Wednesday, May 8, 2024 to discuss the Company's financial results and provide a business update. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alt

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. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, February 27, 2024 to discuss the Company's financial results and provide a business update. The live audio webcast and accompanying slides may be accessed through the Events & Presenta

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

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

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

– 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. Mr. Closter will lead the Company's commercial strategy and operations, including marketing, sales, and market access, succeeding Steve Sabus, who is departing for personal reasons. "Steven Closter is an accompl

- Neil Gallagher, M.D., Ph.D. brings to Syndax over 20 years of experience as a leading oncology drug developer - WALTHAM, Mass., March 30, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Neil Gallagher, M.D., Ph.D., to the role of President, Head of Research and Development (R&D), effective April 10, 2023. Dr. Gallagher brings to Syndax over 20 years of industry experience, most recently serving as Chief Medical Officer, Vice President, Head of Development at AbbVie, where he led multiple development programs through approval globally and over

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. Mr. Sabus brings to Syndax more than 30 years of commercial experience launching drugs and building sales and marketing organizations within the biopharmaceutical industry. As Chief Commercial Officer, Mr. Sabus will oversee all commercial functions, including the development of critical launch initiatives, sales planning and commercial strategy. "Steve is an accomplished executive who has laun

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. Goldan to the role of Chief Financial Officer, effective immediately. Mr. Goldan, who brings to Syndax nearly thirty years of leadership and operational experience at several pharmaceutical, biotechnology, and medical technology companies, most recently served as Chief Financial Officer at Optinose®, where he helped build the infrastructure to support the launch of XHANCE® (fluticasone propionate) in the United States. As Chief Fi

WALTHAM, Mass., March 1, 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 Kate Madigan, M.D., to the role of Chief Medical Officer, effective immediately. Dr. Madigan, who brings to Syndax over 20 years of clinical hematology expertise and broad experience in the design and execution of early to late-stage clinical programs across oncology and rare diseases, will lead the Company's clinical development strategy. She will succeed Michael Meyers, M.D., Ph.D., who will continue with the Company through June before

Company expands leadership team across business and science as it advances precision oncology pipeline Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced the appointment of Daphne Karydas as Chief Operating Officer and Chief Financial Officer, and Michaela Bowden, PhD, as Senior Vice President of Biology and Translation. "We are thrilled to be growing Flare's executive team with the appointment of these two outstanding and accomplished industry leaders, deepening our expertise in areas of business and science and positioning Flare for growth," said Abbie Celniker, PhD, interim Chief Exe

WALTHAM, Mass., Sept. 15, 2021 /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 expansion of its Board of Directors to nine members with the appointment of Martin H. Huber, M.D., effective today. Dr. Huber has over 20 years of academic, biotechnology, and pharmaceutical drug development experience, currently serving as the President of R&D and Chief Medical Officer of Xilio Therapeutics, Inc. "It is my pleasure to welcome industry veteran, Dr. Marty Huber, to the Syndax team," said Dennis Podlesak, Chair of the Board at Syndax. "A