Syndax Hits 52-Week High on Strong Leukemia Drug Data
Shares surge as new real-world and clinical data from the ASH conference reinforce the efficacy of its recently approved drug, revumenib.
Syndax Pharmaceuticals Inc. (NASDAQ: SNDX) saw its shares climb to a 52-week high in Monday trading, propelled by a series of compelling data presentations for its recently approved acute leukemia drug, Revuforj (revumenib). The new clinical and real-world evidence, unveiled at the 67th American Society of Hematology (ASH) Annual Meeting, bolsters the drug's profile just weeks after securing its first FDA approval.
Shares of the biopharmaceutical company traded up approximately 3% to $20.32, touching their highest point in a year. The rally was fueled by data demonstrating revumenib's significant efficacy and favorable safety profile across multiple patient groups. Among the highlights was the first real-world evidence for the menin inhibitor, which showed a 77% overall response rate (ORR) in a heavily pre-treated group of 13 acute leukemia patients, according to a company press release. In this cohort, 31% of patients achieved complete remission or complete remission with partial hematologic recovery.
Even more striking were results from combination therapy trials. In the Phase 2 SAVE trial, revumenib combined with other agents in newly diagnosed patients unfit for intensive chemotherapy produced an 86% overall response rate and a 76% complete remission rate. Crucially, 100% of responders in this trial achieved minimal residual disease (MRD) negativity, a key indicator of deep and potentially durable remission.
“Our results underscore the potential for Revuforj to transform the standard of care for patients with menin-dependent acute leukemias,” said Dr. David Sallman of the Moffitt Cancer Center, who presented the real-world findings. “It is very encouraging to observe the vast majority of patients achieve MRD negative responses and to see a meaningful number of patients proceed to a stem cell transplant.”
The positive data provides powerful commercial and clinical momentum for Syndax. In late November 2024, the U.S. Food and Drug Administration granted accelerated approval to revumenib for the treatment of relapsed or refractory acute leukemia with a specific genetic marker known as a KMT2A rearrangement. The strong results in frontline settings presented at ASH suggest a significant opportunity to expand the drug's use into earlier lines of treatment, a much larger market.
“With the initiation earlier this year of the pivotal frontline trial... and the recent initiation of our pivotal frontline trial in fit patients, Syndax is well positioned to further expand the clinical data supporting revumenib and lead in the frontline setting,” commented Dr. Nick Botwood, Syndax's Chief Medical Officer.
Wall Street has maintained a bullish outlook on the company, which has a market capitalization of approximately $1.77 billion. Even with the recent stock appreciation, the consensus analyst price target for SNDX sits at $39.31, implying considerable upside from its current levels. According to market data provider Benzinga, the stock holds a consensus "Strong Buy" rating among analysts.
As a first-in-class oral menin inhibitor, revumenib represents a novel approach to treating genetically defined leukemias. The data presented at ASH, one of the most prominent conferences in hematology, solidifies its position and sets the stage for Syndax's next phase of growth. Investors will now be closely watching the progress of the company's pivotal trials in frontline leukemia as it seeks to establish revumenib as a cornerstone therapy for a wider patient population.