Syndax Pharmaceuticals, Inc. ( SNDX ) NASDAQ Global Select

Cena: 9.22 ( 0.33% )

Aktualizacja 06-24 20:26
NASDAQ Global Select
Branża: Biotechnology

Notowania:


Informacje o spółce:
Sektor: Zdrowie
Branża: Biotechnology
Zatrudnienie: 184
Giełda: NASDAQ Global Select
Ilość akcji w obrocie: 95%
Ilość akcji: 80 449 000
Debiut giełdowy: 2016-03-02
WWW: https://www.syndax.com
CEO: Mr. Michael A. Metzger M.B.A.
Adres: 35 Gatehouse Drive
Siedziba: 02451 Waltham
ISIN: US87164F1057
Opis firmy:

Syndax Pharmaceuticals, Inc., firma biofarmaceutyczna na stadium klinicznym, opracowuje terapie leczenia raka. Jego kandydatami na produkty wiodącym są SNDX-5613, który jest w badaniu klinicznym fazy 1/2 ukierunkowanej na interakcję wiązania meniny z białkiem 1-biała z mieszanego linii 1 do leczenia mld-zrranowanego (MLLR) i zmutowanego nukleofosminu 1 mutowanej ostrej białaczki mieloidowej mieloidowej (NPM1C AML); oraz Sndx-6352 lub AxatiLimab, przeciwciało monoklonalne, które blokuje czynnik stymulujący kolonię 1 lub receptor CSF-1 w leczeniu pacjentów z przewlekłym przeszczepem w porównaniu z chorobą gospodarza (CGVHD). Firma opracowuje również Entinostat. Posiada również umowę o badaniach i rozwoju z National Cancer Institute; Umowa o badaniu klinicznym z wschodnią grupą spółdzielni Oncology; oraz umowa licencyjna z Kyowa Hakko Kirin Co., Ltd. Syndax Pharmaceuticals, Inc. została włączona w 2005 r. I ma siedzibę w Waltham, Massachusetts.Massachusetts.

Wskaźniki finansowe
Kapitalizacja (USD) 793 357 950
Aktywa: 425 811 000
Cena: 9.22
Wskaźnik Altman Z-Score: 9.7
Stabilny (niskie ryzyko bankructwa)
Dywidenda: 0
P/E: -2.4
Ilość akcji w obrocie: 95%
Średni wolumen: 2 208 324
Ilość akcji 86 047 500
Wskaźniki finansowe
Przychody TTM 16 536 000
Zobowiązania: 59 379 000
Przedział 52 tyg.: 8.58 - 25.07
Piotroski F-Score: 3
Słaby (niska jakość finansowa)
EPS: -3.9
P/E branży: 26.1
Beta: 0.917
Raport okresowy: 2025-07-30
WWW: https://www.syndax.com
Zarząd
Imie i Nazwisko Stanowisko Wynagrodzenie Rok urodzenia
Dr. Neil Gallagher M.D., Ph.D. President, Head of Research & Development 720 455 1964
Mr. Keith Alan Goldan CPA Chief Financial Officer, Treasurer & Chief Accounting Officer 674 650 1971
Dr. Catherine Madigan M.D. Chief Medical Officer 655 840 1972
Mr. Luke J. Albrecht Senior Vice President, General Counsel & Secretary 631 360 1979
Mr. Michael A. Metzger M.B.A. Chief Executive Officer & Director 1 103 616 1971
Dr. Ronald M. Evans Ph.D. Co-Founder, Advisor and Chair of Scientific Advisory Board 0 1949
Dr. Richard A. Heyman Ph.D. Co-Founder 0 1957
Dr. Michael Downes Ph.D. Co-Founder 0 0
Sharon Klahre Vice President of Investor Relations & Communications 0 0
Dr. Peter Ordentlich B.Sc., Ph.D. Co-Founder & Chief Scientific Officer 0 1969
Wiadomości dla Syndax Pharmaceuticals, Inc.
Tytuł Treść Źródło Aktualizacja Link
Syndax Announces Data Presentations at EHA 2025 Showcasing Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) – Revumenib abstracts highlight compelling results in acute leukemia across the frontline and R/R setting and multiple genetic populations, including mNPM1, KMT2Ar, and NUP98r – globenewswire.com 2025-05-14 13:30:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as Head of Research and Development and Chief Medical Officer - Dr. Nicholas Botwood comes to Syndax from BMS and brings 25 years of industry experience leading drug development, R&D strategy and global commercialization of novel oncology therapeutics - globenewswire.com 2025-05-12 20:01:00 Czytaj oryginał (ang.)
Wall Street Analysts See a 219.98% Upside in Syndax (SNDX): Can the Stock Really Move This High? The consensus price target hints at a 220% 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. zacks.com 2025-05-09 15:00:52 Czytaj oryginał (ang.)
Syndax Announces Participation in May Investor Conferences NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative 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: Bank of America Merrill Lynch Vegas Health Care Conference with a fireside chat on Thursday, May 15, 2025, at 9:20 a.m. globenewswire.com 2025-05-08 11:00:00 Czytaj oryginał (ang.)
Syndax Announces Publication of Pivotal Revumenib Data in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia in the Journal Blood – Primary endpoint met in R/R mNPM1 AML patients in pivotal Phase 2 portion of the AUGMENT-101 trial – – Robust remission rates in heavily pre-treated R/R mNPM1 AML population with nearly 50% overall response rate – – sNDA for revumenib in R/R mNPM1 AML submitted in April 2025 – NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) have been published in Blood. “We are thrilled to publish the first positive pivotal dataset in patients with an NPM1 mutation, the most common genetic alteration observed in AML,” said Neil Gallagher, M.D. globenewswire.com 2025-05-07 20:01:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals, Inc. (SNDX) Q1 2025 Earnings Call Transcript Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q1 2025 Earnings Conference Call May 5, 2025 4:30 PM ET Company Participants Sharon Klahre - Head of IR Michael Metzger - Chief Executive Officer and Director Steve Closter - Chief Commercial Officer Neil Gallagher - President and Head of R&D Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Strategy Officer Conference Call Participants Jason Zemansky - Bank of America Ellen Horste - TD Cowen Peter Lawson - Barclays Michael Schmidt - Guggenheim David Dai - UBS Yigal Nochomovitz - Citi Kalpit Patel - B. Riley Securities Jeet Mukherjee - BTIG Salim Syed - Mizuho George Farmer - Scotiabank Operator Good day, everyone, and welcome to the Syndax First Quarter 2025 Earnings Conference Call. seekingalpha.com 2025-05-06 03:18:16 Czytaj oryginał (ang.)
Syndax Pharmaceuticals (SNDX) Reports Q1 Loss, Tops Revenue Estimates Syndax Pharmaceuticals (SNDX) came out with a quarterly loss of $0.98 per share versus the Zacks Consensus Estimate of a loss of $1.04. This compares to loss of $0.85 per share a year ago. zacks.com 2025-05-05 22:10:34 Czytaj oryginał (ang.)
Syndax Reports First Quarter 2025 Financial Results and Provides Business Update – $20.0 million in Revuforj ® (revumenib) net revenue in first full quarter of launch – globenewswire.com 2025-05-05 20:01:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) NEW YORK, May 02, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that on May 1, 2025 the Company granted inducement awards to purchase up to 188,100 shares of common stock to seven 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. globenewswire.com 2025-05-02 20:05:00 Czytaj oryginał (ang.)
Syndax to Announce First Quarter 2025 Financial Results and Host Conference Call and Webcast on May 5, 2025 NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its first quarter 2025 financial results and provide a business update on Monday, May 5, 2025. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. globenewswire.com 2025-04-28 11:00:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on April 1, 2025 the Company granted inducement awards to purchase up to 50,000 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 dates. globenewswire.com 2025-04-04 20:05:00 Czytaj oryginał (ang.)
Syndax Announces Participation at the Stifel 2025 Virtual Targeted Oncology Forum NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- 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 a fireside chat at the Stifel 2025 Virtual Targeted Oncology Forum on Wednesday, April 9, 2025, at 10:30 a.m. globenewswire.com 2025-04-02 11:00:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on March 1, 2025 the Company granted inducement awards to purchase up to 282,000 shares of common stock to 12 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. globenewswire.com 2025-03-05 18:05:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals, Inc. (SNDX) Q4 2024 Earnings Call Transcript Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q4 2024 Earnings Conference Call March 3, 2025 8:00 AM ET Company Participants Sharon Klahre - Head of IR Michael Metzger - CEO Steve Closter - CCO Neil Gallagher - President and Head of R&D Keith Goldan - CFO Anjali Ganguli - CSO Conference Call Participants Anupam Rama - JPMorgan Brad Canino - Stifel Peter Lawson - Barclays Chris Shibutani - Goldman Sachs Kelly Shi - Jefferies Michael Schmidt - Guggenheim Yigal Nochomovitz - Citi David Dai - UBS Justin Zelin - BTIG George Farmer - Scotiabank Jason Zemansky - Bank of America Operator Good day, everyone, and welcome to the Syndax Fourth Quarter and Full Year 2024 Earnings Conference Call. Today's call is being recorded. seekingalpha.com 2025-03-03 13:46:53 Czytaj oryginał (ang.)
Syndax Pharmaceuticals (SNDX) Reports Q4 Loss, Lags Revenue Estimates Syndax Pharmaceuticals (SNDX) came out with a quarterly loss of $1.10 per share versus the Zacks Consensus Estimate of a loss of $1.08. This compares to loss of $1 per share a year ago. zacks.com 2025-03-03 11:15:23 Czytaj oryginał (ang.)
Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update – $7.7 million in Revuforj ® (revumenib) net product revenue in initial five weeks of launch – globenewswire.com 2025-03-03 09:01:00 Czytaj oryginał (ang.)
Syndax Announces Participation in March Investor Conferences WALTHAM, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- 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: globenewswire.com 2025-02-25 09:00:00 Czytaj oryginał (ang.)
Syndax to Announce Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call and Webcast on March 3, 2025 WALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its fourth quarter and full year 2024 financial results and provide a business update on Monday, March 3, 2025. globenewswire.com 2025-02-24 09:00:00 Czytaj oryginał (ang.)
Kuehn Law Encourages Investors of Syndax Pharmaceuticals, Inc. to Contact Law Firm NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. globenewswire.com 2025-02-10 19:42:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) WALTHAM, Mass. , Feb. 4, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that on February 1, 2025 the Company granted inducement awards to purchase up to 124,000 shares of common stock to six new employees under the Company's 2023 Inducement Plan. prnewswire.com 2025-02-04 18:05:00 Czytaj oryginał (ang.)
Syndax Announces Participation in February Investor Conferences WALTHAM, Mass. , Jan. 30, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. prnewswire.com 2025-01-30 09:00:00 Czytaj oryginał (ang.)
Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes – 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. prnewswire.com 2025-01-15 19:34:00 Czytaj oryginał (ang.)
Syndax Highlights Recent Accomplishments and Anticipated 2025 Milestones at the 43rd Annual J.P. Morgan Healthcare Conference – 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 weighing at least 40 kg – – sNDA filing for revumenib in R/R mNPM1 AML expected in 1H25 based on positive pivotal data from AUGMENT-101 trial – WALTHAM, Mass. , Jan. 13, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) will present at the 43rd Annual J.P. prnewswire.com 2025-01-13 09:00:00 Czytaj oryginał (ang.)
Kuehn Law Encourages Investors of Syndax Pharmaceuticals, Inc. to Contact Law Firm NEW YORK , Jan. 7, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. prnewswire.com 2025-01-07 23:20:00 Czytaj oryginał (ang.)
Syndax Announces Presentation at 43rd Annual J.P. Morgan Healthcare Conference 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. prnewswire.com 2025-01-07 09:00:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) 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. prnewswire.com 2025-01-03 18:05:00 Czytaj oryginał (ang.)
SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Is Investigating Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) for Potential Breaches of Fiduciary Duty By Its Board of Directors NEW YORK , Dec. 19, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX). If you are a shareholder of Syndax Pharmaceuticals, Inc. and are interested in obtaining additional information regarding this investigation, free of charge, please visit us at: https://pjlfirm.com/syndax-pharmaceuticals-inc/ You may also contact Robert H. prnewswire.com 2024-12-19 12:37:00 Czytaj oryginał (ang.)
Syndax Announces Additional Positive Data for Revuforj® (revumenib) from AUGMENT-101 Trial in Relapsed or Refractory mNPM1 AML and BEAT AML Frontline Combination Trial – 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 diagnosed mNPM1 or KMT2Ar AML – – BEAT AML data highlight the potential for revumenib to advance the current standard of care – WALTHAM, Mass. , Dec. 9, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced additional positive data from the AUGMENT-101 trial of Revuforj® (revumenib) in relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) and the BEAT AML trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed AML patients. prnewswire.com 2024-12-09 09:30:00 Czytaj oryginał (ang.)
Syndax Presents Positive Revuforj® (revumenib) Data in Acute Leukemias from Multiple Trials, Including the SAVE Combination and AUGMENT-101 Trials, at 66th ASH Annual Meeting –        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 expanded dataset ofPh 2 R/R KMT2Ar acute leukemia patients in AUGMENT-101 – –         Latest data highlight the compelling clinical profile of revumenib and support advancement into combination trials in the frontline setting – WALTHAM, Mass. , Dec. 7, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presented positive data from multiple trials of Revuforj® (revumenib) as a single-agent and in combination with standard of care agents in patients with acute leukemias in oral sessions at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, December 7-10, 2024. prnewswire.com 2024-12-07 20:15:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) 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. prnewswire.com 2024-12-03 18:05:00 Czytaj oryginał (ang.)
Syndax Announces Participation at the Citi 2024 Global Healthcare Conference 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. prnewswire.com 2024-11-27 09:00:00 Czytaj oryginał (ang.)
US FDA approves Syndax's blood cancer drug The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and pediatric patients with a type of blood cancer, sending the company's shares up 3% in after-hours trading. reuters.com 2024-11-15 20:26:51 Czytaj oryginał (ang.)
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. prnewswire.com 2024-11-15 19:29:00 Czytaj oryginał (ang.)
Syndax: Fall On NPM1m AML Data Of Revumenib Creates Buy Opportunity Primary endpoint of pivotal phase 2 study met with statistical significance in using Revumenib for the treatment of relapsed/refractory mNPM1 AML patients; sNDA expected 1st half 2025. PDUFA action date of December 26th of 2024 deployed for FDA to decide if Revumenib should be approved for the treatment of relapsed/refractory KMT2Ar Acute leukemia patients. The global acute myeloid leukemia market is expected to reach $5.86 billion by 2030; About 10% of patients have KMT2Ar AML and then 30% have mNPM1 AML. seekingalpha.com 2024-11-12 18:34:46 Czytaj oryginał (ang.)
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 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced positive topline results from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, an oral, small molecule menin inhibitor. prnewswire.com 2024-11-12 09:00:00 Czytaj oryginał (ang.)
Syndax Pharmaceuticals, Inc. (SNDX) Q3 2024 Earnings Call Transcript Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q3 2024 Earnings Conference Call November 5, 2024 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Neil Gallagher - President & Head, R&D Steve Closter - Chief Commercial Officer Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Strategy Officer Conference Call Participants Priyanka Grover - JPMorgan Brad Canino - Stifel Peter Lawson - Barclays Chris Shibutani - Goldman Sachs Kelly Shi - Jefferies Phil Nadeau - TD Cowen Michael Schmidt - Guggenheim Ashiq Mubarack - Citi Jason Zemansky - Bank of America George Farmer - Scotiabank Kalpit Patel - B. Riley Securities Justin Zelin - BTIG Operator Good day, everyone, and welcome to the Syndax Third Quarter 2024 Earnings Conference Call. seekingalpha.com 2024-11-05 22:39:02 Czytaj oryginał (ang.)