On Wednesday, Goldman Sachs updated its outlook on Syndax Pharmaceuticals (NASDAQ:SNDX), reducing the price target to $31 from the previous $33 while maintaining a Buy rating. The adjustment follows Syndax's announcement of topline results from the AUGMENT-101 trial for revumenib, a menin inhibitor, in patients with relapsed/refractory NPM1 mutant AML.
The trial results revealed a complete response rate of 23%, which, while positive, fell in the lower half of the anticipated 20-30% range. The median duration of response was 4.7 months, slightly below the midpoint of the expected 4-6 months. Despite these figures, a notable 64% of patients achieved MRD negative status.
Safety outcomes were generally favorable, but concerns were raised due to observed QTc prolongations and differentiation syndrome. These issues were noted as manageable by key opinion leaders consulted by Goldman Sachs but could differentiate revumenib from KURA's ziftomenib, which has not shown QTc prolongation.
The investment firm slightly lowered its Probability of Success (PoS) for revumenib in mNPM1 from 60% to 55%. However, Goldman Sachs remains confident in the drug's potential for approval in KMT2Ar leukemias, with an 80-85% PoS and a PDUFA date set for December 26.
Further updates are expected at the upcoming ASH meeting, where SNDX will host an investor event to discuss revumenib's competitive positioning and scope of opportunity.
InvestingPro Insights
Recent InvestingPro data provides additional context to Syndax Pharmaceuticals' current financial situation and market performance. The company's market capitalization stands at $1.38 billion, reflecting its position in the biotech sector. Despite Goldman Sachs maintaining a Buy rating, InvestingPro Tips highlight that SNDX's stock has taken a significant hit over the last week, with a 24.07% decline in price total return. This recent downturn aligns with the mixed trial results for revumenib and the subsequent price target reduction.
Financially, SNDX faces challenges, as indicated by its negative gross profit margin of -301.21% and operating income margin of -2007.57% for the last twelve months. An InvestingPro Tip notes that the company is not profitable over the last twelve months, which is consistent with the developmental stage of its key drug candidates.
On a positive note, InvestingPro Tips reveal that SNDX holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. This financial stability could be crucial as the company navigates the regulatory process for revumenib and continues its research and development efforts.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for SNDX, providing a deeper understanding of the company's financial health and market position.
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