SNDX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-04-30

• We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs.

• Revuforj is our first-in-class menin inhibitor that was approved by the U.S. Food and Drug Administration, or FDA, in November 2024 for the treatment of relapsed or refractory, or R/R, acute leukemia with a lysine methyltransferase 2A gene, or KMT2A, translocation in adult and pediatric patients one…

• Niktimvo is our first-in-class colony stimulating factor-1 receptor, or CSF-1R, blocking antibody that was approved by the FDA in August 2024 for the treatment of chronic graft-versus-host disease, or cGVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patient…

• We licensed the global rights to revumenib and axatilimab, the first two FDA approved medicines to emerge from our pipeline. We are leading the commercialization and further development of revumenib and working closely with our collaboration partner, Incyte, on the commercialization and further deve…

• We have incurred significant operating losses since our inception. While we generate product revenue from sales of Revuforj and collaboration as well as milestone revenue from sales of Niktimvo, we continue to incur significant research and development and other expenses related to our ongoing opera…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved products, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs. Revuforj is our first-in-class menin inhibitor …

• We have begun generating product revenue from sales of Revuforj and collaboration revenue from sales of Niktimvo. We continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in e…

• Achieved $32.0 million in Revuforj net revenue in the third quarter of 2025, representing a 12% increase over the second quarter of 2025. Total Revuforj prescriptions in the third quarter of 2025 were approximately 850, a 25% increase over total prescriptions in the second quarter of 2025.

• Received U.S. FDA approval for Revuforj on October 24, 2025, for the treatment of R/R AML with a susceptible NPM1 mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Revuforj is now the first and only FDA-approved therapy for both R/R A…

• Announced the inclusion of revumenib in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML as a category 2A recommended treatment option for R/R NPM1m AML on September 18, 2025. The guideline update was based on positive pivotal results fro…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• ability to hold our investments until maturity, and therefore, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a change in market interest rates on our investment portfolio.

相对上期新增的文字 · 来源:10-Q · 2026-04-30

• * Contract, instructions, or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

• ** “Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.

• 1 Mr. Podlesak’s plan solely includes equity grants with expiration dates prior to October 31, 2026. The Company omitted inclusion of his plan adoption in its 12/31/2025 filing.