WALTHAM, Mass. - Syndax Pharmaceuticals (NASDAQ:SNDX), a biopharmaceutical company in the clinical stage, has progressed to the Phase 1b segment of its trial for revumenib, following a green light from the Independent Data Monitoring Committee (IDMC). The move is part of a Phase 1/2 proof-of-concept study aimed at treating relapsed or refractory metastatic microsatellite stable colorectal cancer (MSS CRC).
The endorsement comes after the IDMC reviewed initial findings from the Phase 1a part of the trial, which showed a favorable safety profile for revumenib. The oral menin inhibitor, used as a monotherapy, displayed a safety profile consistent with previous data and demonstrated early efficacy signals, including a 33% stable disease rate at 16 weeks.
In the trial, 19 patients who had previously undergone a median of four therapies were enrolled across three dose cohorts. No severe treatment-related adverse events were reported, and the most common were decreased appetite, dysgeusia, nausea, and fatigue. Based on these results, a dosage of 276 mg three times a day was chosen for the next phase of the trial.
Metastatic MSS CRC is the second leading cause of cancer death in the United States, with over 55,000 patients per year in the relapsed or refractory setting. Revumenib targets the menin-MLL1 protein complex, which is believed to play a crucial role in the growth of CRC tumors.
Syndax anticipates presenting pivotal data from the AUGMENT-101 trial in relapsed or refractory NPM1 AML patients in the fourth quarter of 2024. The company is also preparing for potential launches of revumenib and axatilimab later this year. Revumenib has received Orphan Drug Designation, Fast Track designation, and Breakthrough Therapy Designation from the FDA for different leukemia indications.
This advancement is part of Syndax's broader efforts to develop cancer therapies and follows a series of regulatory designations that underscore the potential of revumenib in treating various forms of leukemia. The information presented in this article is based on a press release statement from Syndax Pharmaceuticals.
InvestingPro Insights
As Syndax Pharmaceuticals (NASDAQ:SNDX) continues to make strides in its clinical trials, investors may be evaluating the company's financial health and market performance. In light of the latest developments, here are some key insights from InvestingPro that could be relevant:
InvestingPro Data indicates a market capitalization for SNDX of approximately $1.63 billion USD. While the company's P/E ratio stands at -5.91, reflecting the current lack of profitability, the PEG ratio of 0.2 suggests that investors may expect future growth at a rate that could justify the current earnings multiple.
Two InvestingPro Tips highlight the company's financial position: SNDX holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. This financial stability could support the company's ongoing research and development efforts.
Still, it is important to note that analysts have not forecasted profitability for SNDX this year, and net income is expected to drop. This is underscored by the fact that SNDX has not been profitable over the last twelve months. Moreover, the company does not pay a dividend, which may influence the investment decisions of income-focused shareholders.
For readers looking to delve deeper into Syndax Pharmaceuticals' financials and market performance, InvestingPro offers additional tips. There are currently 8 more tips available on InvestingPro, which can be accessed at https://www.investing.com/pro/SNDX. Interested readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing a more comprehensive understanding of the company's investment potential.
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