SNDX

Syndax Announces Appointment of Steven Closter as Chief Commercial Officer

Retrieved on: 
Monday, March 18, 2024
Psychiatry, Growth, Neurology, Sunovion, Business administration, Cornell University, Patient, CNS, SNDX, Cancer, Marketing, Forest Laboratories, Allergan, Therapy, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • "Steven Closter is an accomplished leader with a proven track record of building commercial teams, leading successful product launches and delivering growth across a broad range of therapeutic areas," said Michael A. Metzger, Chief Executive Officer.
  • Mr. Closter brings to Syndax over 30 years of commercial experience, which included the oversight of over a dozen product launches and indication expansions.
  • Mr. Metzger added: "We thank Steve Sabus for his contributions to Syndax and for his assistance in seamlessly transitioning the role to Steven Closter.

Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

Retrieved on: 
Tuesday, February 27, 2024
FDA, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, Food, BLA, PDUFA, SNDX, GVHD, Safety, Society, Patient, Priority, Biologics license application, Priority review, Pharmaceutical industry

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
  • The Prescription Drug User Fee Act (PDUFA) date for the FDA decision is August 28, 2024.
  • Axatilimab is being developed by Incyte and Syndax Pharmaceuticals (Nasdaq:SNDX) as part of an exclusive worldwide co-development and co-commercialization license agreement.
  • “Axatilimab’s novel mechanism offers a differentiated treatment approach which may help patients suffering from this devastating disease.

Syndax Announces Participation at Two Upcoming Investor Conferences

Retrieved on: 
Monday, February 26, 2024
SNDX, Leukemia, Conference, Pharmaceutical industry

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:

Key Points: 
  • 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 44th Annual Health Care Conference at 9:50 a.m.
  • ET on Monday, March 4, 2024 in Boston, MA
    A corporate panel discussion on leukemia at TD Cowen's 44th Annual Health Care Conference at 12:50 p.m.
  • ET on Monday, March 4, 2024 in Boston, MA
    A fireside chat at the Barclays Global Healthcare Conference at 8:30 a.m.
  • ET on Tuesday, March 12, 2024 in Miami, FL
    A live webcast of these sessions can be accessed from the Investor section of the Company's website at www.syndax.com , where a replay will also be available for a limited time.

Syndax Announces Participation at Two Upcoming Investor Conferences

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Conference, Citigroup, Guggenheim, SNDX, Pharmaceutical industry

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:

Key Points: 
  • 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 fireside chat at the Citi 2024 Virtual Oncology Leadership Summit at 2:00 p.m.
  • A live webcast of the fireside chats can be accessed from the Investor section of the Company's website at www.syndax.com , where a replay of the events will also be available for a limited time.

Syndax Announces Presentation at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Tuesday, January 2, 2024
Conference, SNDX

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.

Key Points: 
  • 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 accessed from the Investor section of the Company's website at www.syndax.com , where a replay of the event will also be available for a limited time.

Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease

Retrieved on: 
Sunday, December 10, 2023
Health, Surgery, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Fascia, Safety, Kaplan–Meier estimator, Food, Head, Esophagus, BLA, ASH, Lipase, Liver, Disease, Macrophage, Patient, Multimedia, Abstract, FDA, Joint, GVHD, CRS, GI, SNDX, ORR, Chocolate liquor, Development, Death, Mouth, Society, Skin, Biologics license application, Inflammation, Fibrosis, Pharmaceutical industry

The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.

Key Points: 
  • The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.
  • Organ-specific responses, including complete responses (CRs), were seen across all organs involved at baseline, including lower gastrointestinal (GI), upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin.
  • Additionally, responses were notable in fibrosis-dominated organs, including the esophagus (78%), joints and fascia (76%), lungs (47%) and skin (27%).
  • "Full results from the AGAVE-201 trial show rapid durable responses documented in all organs and patient subgroups, with significant symptom burden reduction reported by most of these heavily-pretreated patients.

Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting

Retrieved on: 
Tuesday, December 12, 2023
Data, Principal, Trae Waynes, Pivotal, Associate professor, Food, Postcholecystectomy syndrome, Transplant, City, HSCT, Acute myeloid leukemia, ASH, Cytopenia, DS, Haematopoietic system, Publication, MRD, Division, QT interval, CRC, CRH, SNDX, CYP3A4, Acute leukemia, Nausea, ORR, 65th Armoured Regiment (India), AML, Society, Female, Poster, ALL, Safety, Vaccine, Pharmaceutical industry, Nursing, Leukemia, Hematology, Patient

The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."

Key Points: 
  • The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."
  • Minimal residual disease (MRD) status was assessed in 10 of the 13 patients who achieved a CR/CRh, 70% (7/10) of whom were MRD negative.
  • In adults with AML (n=51), the CR/CRh rate was 37.3% and ORR was 68.6%, with 40% of responders proceeding to HSCT.
  • Copies of the ASH presentations are available in the Publications and Meeting Presentations section of Syndax's website.

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

Retrieved on: 
Friday, December 1, 2023
SNDX, Pharmaceutical industry

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.

Key Points: 
  • 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% 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 dates.

Syndax Announces Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Selected as Late-Breaking Presentation at the 65th ASH Annual Meeting

Retrieved on: 
Tuesday, November 21, 2023
ASH, Society, Pivotal, SNDX, FDA, Safety, Pharmaceutical industry, Patient

A copy of the abstract is now available online via the ASH website at www.hematology.org .

Key Points: 
  • A copy of the abstract is now available online via the ASH website at www.hematology.org .
  • "We are pleased the ASH program committee recognized AUGMENT-101 as a substantive study of high impact and selected it as a late-breaker presentation this year," said Michael A. Metzger, Chief Executive Officer.
  • "We believe the AUGMENT-101 results continue to underscore revumenib's potential as a first- and best-in-class treatment option for patients with KMT2Ar and mNPM1 acute leukemias.
  • Details of the presentation are as follows:
    Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study

Syndax Announces Participation at Stifel Healthcare Conference

Retrieved on: 
Tuesday, November 7, 2023
SNDX, Conference, Pharmaceutical industry, Online shopping

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.

Key Points: 
  • 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 accessed from the Investor section of the Company's website at www.syndax.com , where a replay of the event will also be available for a limited time.