U.S. launch expected in early February Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis Pivotal data from the AGAVE-201 trial supporting FDA approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups WILMINGTON, Del. and WALTHAM, Mass. , Jan. 15, 2025 /PRNewswire/ -- Incyte... Read More

Launched Revuforj ® (revumenib) for treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older Revumenib added to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for AML and ALL Niktimvo™ (axatilimab-csfr) 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... Read More

WALTHAM, Mass. , Jan. 7, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025 at 10:30 a.m. PT / 1:30 p.m. ET . A live webcast of the fireside chat... Read More

WALTHAM, Mass. , Jan. 3, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on January 1, 2025 the Company granted inducement awards to purchase up to 123,100 shares of common stock to five new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

Subgroup analyses from Ph 2 protocol-defined R/R mNPM1 AML efficacy population (N=64) show responses across all major subgroups, including heavily pretreated patients 26% CR+CRh (20/77) and 48% ORR (37/77) in all enrolled patients who met the efficacy evaluable criteria in Ph 2 R/R mNPM1 AML cohort 100% ORR (37/37) and 95% CRc (35/37) in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly... Read More

82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML 64% ORR (62 of 97 pts) and 23% CR/CRh (22 of 97 pts) with high rates of MRD negativity and ability to proceed to HSCT in expanded dataset of Ph 2 R/R KMT2Ar acute leukemia patients in AUGMENT-101 Responses were rapid, durable and observed across all major subgroups in... Read More

WALTHAM, Mass. , Dec. 3, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on December 1, 2024 the Company granted inducement awards to purchase up to 23,900 shares of common stock to two new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

WALTHAM, Mass. , Nov. 27, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will participate in a panel discussion on novel mechanisms in oncology at the Citi 2024 Global Healthcare Conference on Thursday, December 5, 2024 at 11:00 a.m. ET.... Read More

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 ®... Read More

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... Read More

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 therapy in adult and... Read More

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 66 th American Society of Hematology (ASH) Annual Meeting in San Diego,... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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. Metzger , Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in the following upcoming investor conferences: Guggenheim's Inaugural Healthcare Innovation... Read More

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... Read More

WALTHAM, Mass. , Oct. 4, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on October 1, 2024 the Company granted inducement awards to purchase up to 62,700 shares of common stock to five new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

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... Read More

WALTHAM, Mass. , Sept. 6, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on September 1, 2024 the Company granted an inducement award to purchase up to 60,000 shares of common stock to one new employee under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

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... Read More

WALTHAM, Mass. , Aug. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on August 1, 2024 the Company granted inducement awards to purchase up to 104,600 shares of common stock to nine new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

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/ --... Read More

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... Read More

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... Read More

WALTHAM, Mass. , July 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on July 1, 2024 the Company granted inducement awards to purchase up to 124,000 shares of common stock to eight new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25% of... Read More

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 WALTHAM, Mass. ,... Read More

IDMC recommendation to advance based on favorable safety profile observed in Phase 1a portion of trial WALTHAM, Mass. , June 6, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it has advanced into the Phase 1b portion of its Phase 1/2 proof-of-concept trial of revumenib, the Company's highly... Read More

WALTHAM, Mass. , June 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024 , at 8:40 a.m. ET . A live webcast of the fireside... Read More

WALTHAM, Mass. , June 3, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on June 1, 2024 the Company granted inducement awards to purchase up to 499,200 shares of common stock to fifty-three new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

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... Read More

WALTHAM, Mass. , May 9, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that members of the Syndax management team will participate in a fireside chat at the Bank of America Securities 2024 Health Care Conference on Thursday, May 16, 2024 , at 8:00 a.m. PT / 11:00 a.m. ET . A live webcast of the... Read More

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... Read More

WALTHAM, Mass. , May 3, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on May 1, 2024 the Company granted inducement awards to purchase up to 100,600 shares of common stock to six new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25% of the... Read More

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... Read More

WALTHAM, Mass. , April 10, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will participate in a fireside chat at the at Stifel 2024 Virtual Targeted Oncology Forum on Wednesday, April 17, 2024 , at 11:00 a.m. ET . A live webcast of the... Read More

Consistent safety and efficacy profiles across adult and pediatric populations Majority of pediatric patients who achieved an overall response proceeded to transplant; patients receiving post-transplant revumenib maintenance remained in remission as of data cutoff date No treatment-related discontinuations or dose reductions WALTHAM, Mass. , April 8, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ: SNDX), a clinical... Read More

WALTHAM, Mass. , April 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on April 1, 2024 the Company granted inducement awards to purchase up to 164,200 shares of common stock to ten new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25% of... Read More

Topline data expected in 4Q24 could support sNDA filing in 1H25 Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity WALTHAM, Mass. , March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal... Read More

PDUFA action date set for September 26, 2024 NDA being reviewed under FDA's RTOR program WALTHAM, Mass. , March 26, 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 granted Priority Review for its New Drug Application (NDA) for revumenib, the... Read More

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... Read More

WALTHAM, Mass. , March 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on March 1, 2024 the Company granted inducement awards to purchase up to 42,800 shares of common stock to three new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 NDA for revumenib in R/R KMT2Ar acute leukemia submitted under FDA's RTOR program; PDUFA date assignment expected in 1Q24 Enrollment in AUGMENT-101 mNPM1 patient cohort expected to complete in late 1Q/early 2Q; topline data in 4Q24 Initiated revumenib Phase 1 combination trial with 7+3 chemotherapy in newly diagnosed... Read More

WALTHAM, Mass. , Feb. 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (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 the following sessions at two upcoming investor conferences: A fireside chat at TD Cowen's 44 th Annual Health Care Conference at 9:50 a.m. ET on Monday , March 4, 2024 in... Read More

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... Read More

WALTHAM, Mass. , Feb. 2, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on February 1, 2024 the Company granted inducement awards to purchase up to 127,300 shares of common stock to eight new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

WALTHAM, Mass. , Feb. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (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 two upcoming investor conferences: A fireside chat at the Guggenheim 6th Annual Biotechnology Conference at 10:00 a.m. ET on Thursday, February 8, 2024 in New York, NY . A... Read More

WALTHAM, Mass. , Jan. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on January 1, 2024 the Company granted inducement awards to purchase up to 8,600 shares of common stock to one new employee under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25% of... Read More

WALTHAM, Mass. , Jan. 2, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 5:15 p.m. PT / 8:15 p.m. ET . A live webcast of the fireside chat can be... Read More

BLA submitted for axatilimab in chronic graft-versus-host disease; Syndax exercised option to co-commercialize axatilimab in the U.S. with Incyte NDA submitted for revumenib in R/R KMT2Ar acute leukemia under U.S. FDA's RTOR program Completion of enrollment in AUGMENT-101 mNPM1 patient cohort expected in late 1Q/early 2Q with topline data anticipated in 4Q24 Completion of $230 million follow-on offering in December extends... Read More

WALTHAM, Mass. , Dec. 19, 2023 /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 closing of its previously announced underwritten public offering of 12,432,431 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase... Read More

WALTHAM, Mass. , Dec. 14, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax" or the "Company") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the pricing of an underwritten public offering of 10,810,810 shares of its common stock. The public offering price of each share of common stock is $18.50 . The aggregate gross proceeds from... Read More

WALTHAM, Mass. , Dec. 14, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax" or the "Company") (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 also expects to grant the... Read More

Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); CR/CRh rate consistent across adult and pediatric patients 63% overall response rate; responses observed across all major subgroups Median overall survival at time of data cutoff of 8.0 months Favorable safety and tolerability profile; treatment discontinuations were low at 6% with none due to... Read More

Data collectively highlight revumenib's combination potential with current standard of care agents and support advancement into pivotal combination trials in the frontline setting 100% CRc observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML 78% CRc observed in SAVE AML trial, an all-oral combination of revumenib, venetoclax and... Read More

WALTHAM, Mass. , Dec. 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical 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 11, 2023 , at 7:00 a.m. PT / 10:00 a.m. ET during the 65 th American Society of Hematology (ASH) Annual Meeting in San Diego,... Read More

WALTHAM, Mass. , Dec. 1, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on December 1, 2023 the Company granted inducement awards to purchase up to 158,000 shares of common stock to nine new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

WALTHAM, Mass. , Nov. 21, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that data from the pivotal trial of revumenib, the Company's highly selective, oral menin inhibitor, will be featured in a late-breaking presentation at the 65 th American Society of Hematology (ASH) Annual Meeting being held... Read More

WALTHAM, Mass. , Nov. 7, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will participate in a fireside chat at the Stifel Healthcare Conference on Tuesday, November 14, 2023 , at 4:45 p.m. ET . A live webcast of the fireside chat can be... Read More

WALTHAM, Mass. , Nov. 3, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on November 1, 2023 the Company granted inducement awards to purchase up to 169,600 shares of common stock to ten new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under RTOR mNPM1 final efficacy data from the Phase 1 portion of AUGMENT-101 demonstrates a 36% CR/CRh rate Revumenib and axatilimab U.S. registrational filings on track for year-end 2023 completion and potential 2024 approvals Axatilimab to be featured in plenary session at 65th ASH Annual Meeting Revumenib pivotal monotherapy results, combination with... Read More

Results support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R monoclonal antibody in chronic graft-versus-host disease Syndax and Incyte intend to file a Biologics License Application (BLA) by year-end 2023 WALTHAM, Mass. , Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals ( Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative... Read More

Additional data from pivotal AUGMENT-101 trial in R/R KMT2Ar acute leukemia further highlight revumenib's potential best-in-class profile \ 100% ORR (n=7) and manageable safety profile observed in Phase 1 results of SAVE trial, an all-oral combination regimen of revumenib plus venetoclax-decitabine/cedazuridine in R/R AML Patients re-started on treatment with revumenib in post-transplant maintenance exhibit durable MRD... Read More

WALTHAM, Mass. , Oct. 26, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its third quarter 2023 financial results and provide a business update on Thursday, November 2 , after the close of the U.S. financial markets. In connection with the earnings release, Syndax's management... Read More

Solidifies first-to-market potential for revumenib High unmet need in relapsed or refractory KMT2Ar patients in the U.S. provides a strong foundation for revumenib commercial launch WALTHAM, Mass. , Oct. 24, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will submit a New Drug... Read More

WALTHAM, Mass. , Oct. 6, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on October 1, 2023 the Company granted inducement awards to purchase up to 121,150 shares of common stock to eight new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

Trial met its primary endpoint with a CR/CRh rate of 23% at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); an additional 14% of patients proceeded to transplant without achieving CR/CRh 65% (32/49) overall response rate in KMT2Ar AML; CR/CRh rate of 24.5% 50% (7/14) of transplanted patients have initiated, and 21% (3/14) of transplanted patients could initiate revumenib as post-transplant... Read More

WALTHAM, Mass. , Sept. 29, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will host a conference call and live webcast to share topline results from the pivotal AUGMENT-101 trial in patients with relapsed/refractory KMT2Ar acute leukemia on Monday, October 2, 2023 at 8:00 a.m. ET . The live... Read More

WALTHAM, Mass. , Sept. 1, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on September 1, 2023 the Company granted inducement awards to purchase up to 149,200 shares of common stock to seven new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

WALTHAM, Mass. , Aug. 31, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will participate in a Targeted Oncology panel discussion at the Citi 18th Annual BioPharma Conference on Wednesday, September 6, 2023 at 1:00 p.m. A live webcast of... Read More

WALTHAM, Mass. , Aug. 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on August 1, 2023 the Company granted inducement awards to purchase up to 118,000 shares of common stock to nine new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

Announced positive topline results from the pivotal AGAVE-201 trial of axatilimab in cGVHD Topline data from the pivotal AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia on track for the third quarter of 2023 Two U.S. registrational filings expected by the end of 2023 Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass. , Aug. 3, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a... Read More

WALTHAM, Mass. , July 25, 2023 /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 2023 financial results and provide a business update on Thursday, August 3 , after the close of the U.S. financial markets. In connection with the earnings release, Syndax's management will... Read More

Trial met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks Data highlight durable response to treatment. At the 0.3 mg/kg dose, 60% of patients who responded to axatilimab were still responding at one year Results continue to support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R... Read More

WALTHAM, Mass. , July 7, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on July 1, 2023 the Company granted inducement awards to purchase up to 31,400 shares of common stock to two new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with 25%... Read More

WALTHAM, Mass. , June 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on June 1, 2023 the Company granted inducement awards to purchase up to 397,900 shares of common stock to eighteen new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years,... Read More

WALTHAM, Mass. , May 24, 2023 /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 two upcoming investor conferences: A virtual fireside chat at the TD Cowen 4th Annual Oncology Innovation Summit at 2:30 p.m. ET on Wednesday , May 31, 2023. A... Read More

Topline data from the pivotal AGAVE-201 trial of axatilimab in cGVHD on track for mid-2023 Topline data from the pivotal AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia on track for the third quarter of 2023 Two U.S. registrational filings expected by the end of 2023 Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass. , May 8, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a... Read More

WALTHAM, Mass. , May 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on May 1, 2023 the Company granted inducement awards to purchase up to 272,000 shares of common stock to fifteen new employees under the Company's 2023 Inducement Plan. The stock options will vest over four years, with... Read More

WALTHAM, Mass. , May 1, 2023 /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 first quarter 2023 financial results and provide a business update on Monday, May 8 , after the close of the U.S. financial markets. In connection with the earnings release, Syndax's management will... Read More

WALTHAM, Mass. , April 13, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that in connection with the hiring, announced on April 10, 2023, of Neil Gallagher, M.D., Ph.D., as President, Head of Research and Development, Dr. Gallagher received an inducement award to purchase up to 250,000 shares... Read More

WALTHAM, Mass. , April 7, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on April 3, 2023 the Company granted inducement awards to purchase up to 121,100 shares of common stock to six new employees under the Company's 2023 Inducement Plan. The stock options have an exercise price per share... Read More

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... Read More

WALTHAM, Mass. , March 15, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced that data from the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial of revumenib in patients with nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2Ar) relapsed/refractory (R/R) acute leukemia and an analysis describing MEN1 mutations observed in the study have been published in the journal Nature.... Read More

WALTHAM, Mass. , March 6, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on March 1, 2023 the Company granted an inducement award to purchase up to 15,200 shares of common stock to one new employee under the Company's 2023 Inducement Plan. The stock option has an exercise price per share... Read More

Topline data from AUGMENT-101 KMT2Ar patients expected in the third quarter of 2023 Topline data from the pivotal AGAVE-201 trial on track for mid-2023 Two U.S. registrational filings expected by the end of 2023 Company to host conference call today at 4:30 p.m. ET WALTHAM, Mass. , Feb. 28, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative... Read More

WALTHAM, Mass. , Feb. 21, 2023 /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 fourth quarter and year-end 2022 financial results and provide a business update on Tuesday, February 28 , after the close of the U.S. financial markets. In connection with the earnings release,... Read More

WALTHAM, Mass. , Feb. 14, 2023 /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 the upcoming investor conferences: A fireside chat at the Citi 2023 Virtual Oncology Leadership Summit at 2:00 p.m. ET on Tuesday, February 21, 2023 A fireside chat... Read More

WALTHAM, Mass. , Jan. 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger , Chief Executive Officer of Syndax, will present at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 10:30 a.m. PT / 1:30 p.m. ET . A live webcast of the... Read More

WALTHAM, Mass. , Dec. 14, 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 closing of its previously announced underwritten public offering of 7,840,909 shares of its common stock at a price to the public of $22.00 per share. This includes the exercise in... Read More

30% CR/CRh rate in efficacy evaluable population; 27% CR/CRh rate observed in both mNPM1 and KMT2Ar (MLLr) R/R acute leukemia patients treated at RP2D 9 of 12 patients who underwent stem cell transplant after achieving a response with revumenib remained in remission, with four continuing beyond one year Company to host conference call and webcast on Sunday, December 11, 2022 at 8:00 a.m. CT / 9:00 a.m. ET WALTHAM, Mass. ,... Read More

WALTHAM, Mass. , Dec. 8, 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 in connection with the hiring, announced on December 5, 2022 , of Steve M. Sabus as Chief Commercial Officer, Mr. Sabus received an inducement award to purchase up to 220,000 shares of... Read More

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 the pricing of an underwritten public offering of 6,818,182 shares of its common stock. The public offering price of each share of common stock is $22.00 . The aggregate gross proceeds from... Read More

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 also expects to grant the... Read More

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,... Read More

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. , Dec. 5, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc.... Read More

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... Read More