Syndax Pharmaceuticals Inc Stock Price, News & Analysis

Syndax Pharmaceuticals (SNDX) reported Q3 2024 financial results with a net loss of $84.1 million ($0.98 per share). The company secured FDA approval for Niktimvo for chronic GVHD treatment and expects its launch by early Q1 2025. A $350 million royalty funding agreement with Royalty Pharma was announced. The company's revumenib NDA for R/R KMT2Ar acute leukemia has a PDUFA date of December 26, 2024. Cash position stands at $399.6 million, with R&D expenses increasing to $71.0 million and SG&A expenses rising to $31.1 million. Full-year 2024 operating expenses are projected at $365-370 million.

Syndax Pharmaceuticals (SNDX) has announced an upcoming investor event scheduled for December 9, 2024, at 7:00 a.m. PT/10:00 a.m. ET during the 66th American Society of Hematology Annual Meeting in San Diego. The event will be held both in-person and via webcast.

The company's management team will collaborate with key opinion leaders to present updates on their revumenib and Niktimvo™ (axatilimab-csfr) programs. Interested parties can access the live webcast through the Investor section of Syndax's website, where a recording will also be available temporarily.

Syndax Pharmaceuticals (SNDX) announced new data from secondary analysis of the AGAVE-201 trial for Niktimvo™ (axatilimab-csfr) in chronic graft-versus-host disease to be presented at the ASH Annual Meeting. The pivotal trial met its primary endpoint with a 75% overall response rate at the approved dose of 0.3 mg/kg. More than half of responders showed clinical response by day 56, with an estimated 60% maintaining response at 12 months. Organ-specific responses ranged from 1.2 to 3.7 months, with GI tract, liver, and joints responding faster than lung, mouth, eye, and skin manifestations.

Syndax Pharmaceuticals (SNDX) presented positive data for revumenib, their oral menin inhibitor, at the ASH Annual Meeting. Key highlights include:

- 64% Overall Response Rate (62/97) in patients with R/R KMT2Ar acute leukemia in Phase 2 AUGMENT-101 pivotal cohort

- 88% Overall Response Rate (23/26) in SAVE trial testing revumenib combination therapy in R/R AML

The FDA has granted Priority Review for revumenib's New Drug Application with a PDUFA date of December 26, 2024. The company also completed enrollment for the final AUGMENT-101 pivotal trial cohort in R/R mNPM1 AML patients, with topline data expected in Q4 2024.

Syndax Pharmaceuticals (SNDX) has secured a $350 million synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo™. Under the agreement, Syndax will provide a 13.8% royalty on U.S. net sales until reaching a 2.35x multiple. The funding is expected to support the upcoming product launches and development of Niktimvo and revumenib, with proforma cash approaching $800 million as of June 30. The deal aims to fund Syndax through profitability while maintaining participation in Niktimvo's profits and future growth potential. Niktimvo is positioned as a first-in-class treatment for chronic graft-versus-host disease (GVHD).

Syndax Pharmaceuticals (Nasdaq: SNDX) announced the granting of inducement awards to four new employees on November 1, 2024. The awards consist of stock options to purchase up to 78,700 shares of common stock under the Company's 2023 Inducement Plan. The options will vest over four years, with 25% vesting after one year and the remaining vesting monthly over the following 36 months, contingent on continued employment with Syndax.

Syndax Pharmaceuticals (SNDX) announced its participation in four major healthcare investor conferences in November 2024. The company's CEO Michael A. Metzger and management team will attend: Guggenheim's Inaugural Healthcare Innovation Conference in Boston (Nov 13), UBS Global Healthcare Conference in Ranchos Palos Verdes (Nov 14), Stifel 2024 Healthcare Conference in New York (Nov 18), and Jefferies London Healthcare Conference (Nov 20-21). Live webcasts of the fireside chats will be available on the company's website.

Syndax Pharmaceuticals (SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has scheduled its third quarter 2024 financial results announcement and business update for November 5, 2024. The company will host a conference call and live audio webcast at 4:30 p.m. ET on the same day. Management will discuss financial results and provide business updates during the call, which will be accessible via phone or webcast. A replay will be available on the company's website for 90 days following the call.

Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, has announced the granting of inducement awards under its 2023 Inducement Plan. On October 1, 2024, the company granted stock options to five new employees, allowing them to purchase up to 62,700 shares of common stock.

The stock options have a four-year vesting schedule. Specifically, 25% of the underlying shares will vest on the one-year anniversary of the vesting commencement date. Following that, 1/48th of the underlying shares will vest monthly over the next 36 months. These vesting terms are subject to the employee's continued service relationship with Syndax throughout the applicable vesting dates.