Syndax’s Revumenib Shows Promising Results in Acute Leukemia Trials, Paving Way for FDA Approval

The information provided in the search results does not support the claim that Syndax's small molecule underwhelmed investors in a midstage acute leukemia trial, leading to a 22% stock drop. Instead, the data presented in the sources indicate positive outcomes for revumenib in treating acute leukemias:

1. Positive Data in Acute Leukemia Trials:

* - AUGMENT-101 Trial:*
Revumenib achieved a 23% complete remission rate in patients with relapsed/refractory KMT2A-rearranged acute leukemia, with a well-tolerated safety profile and durable responses134.

* - SAVE Trial:*
The combination of revumenib, venetoclax, and decitabine/cedazuridine resulted in an 88% overall response rate (ORR) in patients with R/R AML, with a 58% CR/CRh rate and 93% MRD negativity among CR/CRh responders1.

* - BEAT AML Trial:*
Revumenib in combination with venetoclax/azacitidine achieved a 96% CRc rate in newly diagnosed mNPM1 or KMT2Ar AML, with 92% of patients attaining MRD-negative status25.

2. Investor Reaction:

• The provided sources do not mention a 22% stock drop due to underwhelming results. Instead, they highlight the positive data and the potential for revumenib to be a practice-changing therapy in acute leukemias.

AUGMENT-101 Trial:
23% CR/CRh rate in R/R KMT2Ar acute leukemia.

SAVE Trial:
88% ORR and 58% CR/CRh rate in R/R AML with revumenib combination.

BEAT AML Trial:
96% CRc rate in newly diagnosed mNPM1 or KMT2Ar AML with revumenib combination.

FDA Approval:
Expected in the fourth quarter of 2024 for R/R KMT2Ar acute leukemias.

Sources:

1. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-revumenib-abstracts-be-presented-66th-ash

2. https://ir.syndax.com/news-releases/news-release-details/syndax-presents-updated-positive-data-beat-aml-and-augment-102

3. https://www.targetedonc.com/view/augment-101-trial-of-revumenib-meets-primary-end-point-in-kmt2ar-acute-leukemia

4. https://www.drugs.com/clinical_trials/syndax-announces-positive-pivotal-topline-results-relapsed-refractory-mnpm1-aml-cohort-augment-101-21756.html

5. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-positive-data-revumenib-patients-acute