Syndax Pharmaceuticals Inc Stock Price, News & Analysis

Syndax Pharmaceuticals (SNDX) has scheduled its fourth quarter and full year 2024 financial results announcement and business update for Monday, March 3, 2025. The company will host a conference call and live audio webcast at 8:00 a.m. ET on the same day.

Investors and interested parties can access the webcast through the Events & Presentations page in the Investors section of Syndax's website. Alternative access is available via phone using the conference ID: Syndax4Q24, with domestic dial-in number 800-590-8290 and international dial-in number 240-690-8800.

A replay of the conference call will be available on the company's website approximately 24 hours after the event and will remain accessible for 90 days.

Syndax Pharmaceuticals (SNDX) has announced the granting of inducement awards under its 2023 Inducement Plan. The company granted stock options to purchase up to 124,000 shares of common stock to six new employees on February 1, 2025. These stock options follow a four-year vesting schedule, with 25% of shares vesting after the first year, followed by monthly vesting of 1/48th of the underlying shares over the subsequent 36 months. The vesting is contingent upon continued employment with Syndax.

Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has announced its participation in two upcoming investor conferences in February 2025. CEO Michael A. Metzger and the management team will attend:

1. The Guggenheim SMID Cap Biotech Conference in New York, featuring a fireside chat on February 6, 2025, at 10:30 a.m. ET

2. Citi's 2025 Virtual Oncology Leadership Summit, with a fireside chat scheduled for February 19, 2025, at 9:00 a.m. ET

Both presentations will be available via webcast on the company's website investor section, with replays accessible for a time.

Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes, with U.S. launch expected in early February. Niktimvo is the first FDA-approved treatment targeting CSF-1R for chronic graft-versus-host disease (GVHD) in patients who failed at least two prior systemic therapies.

The approval was based on the AGAVE-201 trial results, where 75% of patients receiving 0.3 mg/kg every two weeks achieved response at six months. The approved dose is 0.3 mg/kg (max 35 mg) via intravenous infusion every two weeks for patients weighing at least 40 kg.

Notable adverse reactions occurred in 44% of patients, with 10% discontinuing treatment. The most common side effects included increased AST, infections, and decreased phosphate levels. The treatment has been added to NCCN Guidelines as a category 2A recommendation.

Syndax Pharmaceuticals (SNDX) highlighted its achievements and 2025 milestones, featuring two major FDA approvals in 2024: Revuforj® for R/R acute leukemia with KMT2A translocation and Niktimvo™ for chronic GVHD treatment. Both drugs were added to NCCN Clinical Practice Guidelines.

Key developments include positive results from the AUGMENT-101 trial for Revuforj, with plans to submit an sNDA for R/R mNPM1 AML in 1H25. The company secured a $350 million royalty funding agreement with Royalty Pharma for Niktimvo's U.S. sales.

2025 milestones include launching Niktimvo in Q1, maximizing Revuforj adoption, and initiating multiple frontline trials. The company expects its current financial position to support operations through profitability.

Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, announced that CEO Michael A. Metzger will present at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Tuesday, January 14, 2025, at 10:30 a.m. PT/ 1:30 p.m. ET. Interested parties can access a live webcast of the fireside chat through the Investor section of Syndax's website, where a replay will also be available temporarily.

Syndax Pharmaceuticals (SNDX) announced the granting of inducement awards to five new employees on January 1, 2025. The awards consist of stock options to purchase up to 123,100 shares of common stock under the Company's 2023 Inducement Plan. The vesting schedule spans four years, with 25% of shares vesting after the first year and the remaining 1/48th vesting monthly over the subsequent 36 months, contingent on continued employment with Syndax.

Syndax Pharmaceuticals (SNDX) announced additional positive data from two clinical trials for Revuforj® (revumenib): the AUGMENT-101 trial in relapsed/refractory mNPM1 AML and the BEAT AML frontline combination trial. Key highlights include:

In the AUGMENT-101 trial's Phase 2 cohort, the protocol-defined efficacy population showed 23% CR+CRh rate and 47% ORR. In the expanded analysis of 77 evaluable patients, 26% achieved CR+CRh and 48% achieved overall response.

The BEAT AML trial, combining revumenib with venetoclax/azacitidine in newly diagnosed patients, demonstrated remarkable results with 100% ORR (37/37) and 95% CRc (35/37). The safety profile remained consistent with previous data, showing manageable differentiation syndrome and QTc prolongation events.

Syndax Pharmaceuticals (SNDX) presented positive data from multiple trials of Revuforj® (revumenib) at the 66th ASH Annual Meeting. Key highlights include:

- SAVE trial: 82% overall response rate (27/33 patients) and 48% CR/CRh rate (16/33 patients) in combination with venetoclax and decitabine/cedazuridine in R/R AML

- AUGMENT-101 trial: 64% overall response rate (62/97 patients) and 23% CR/CRh rate (22/97 patients) in R/R KMT2Ar acute leukemia patients, with high MRD negativity rates

- INTERCEPT trial: 54% (6/11) of evaluable mNPM1 patients showed MRD reduction, with 36% (4/11) achieving MRD negativity

The drug demonstrated rapid responses, durability, and favorable tolerability across trials.