Stifel, a financial services firm, revised its price target for Syndax Pharmaceuticals (NASDAQ: NASDAQ:SNDX), decreasing it to $40 from $42, while retaining a Buy rating on the stock based on the news that the U.S. Food and Drug Administration (FDA) has extended the approval decision for Syndax's drug candidate revumenib by three months.
The delay was unexpected, as recent research indicated that approvals under the Real-Time Oncology Review (RTOR) program could be anticipated one to two months earlier than the standard timeline.
The management of Syndax Pharmaceuticals communicated that the postponement was due to the need for additional analysis of data submitted after the New Drug Application (NDA). The company remains confident in the drug's prospects and suggests that the delay is more about the time required to review the late-cycle Request for Information (RFI) than concerns about the data's content. Despite the delay, Stifel maintains a high probability of success (PoS) for the drug's approval in relapsed/refractory (R/R) KMT2Ar leukemia.
The extension of the FDA's decision timeline has led Stifel to eliminate projected third-quarter sales from its market model for Syndax and to reduce out-year revenue estimates by 4-5% due to an anticipated slower ramp-up following approval.
The development has also sparked discussions among investors about the potential for a competing drug, KURA, to assert market share leadership in acute myeloid leukemia (AML) in the longer term.
Recently, Syndax has disclosed that the U.S. Food and Drug Administration (FDA) extended the review period for its New Drug Application (NDA) for revumenib, a therapy for relapsed or refractory KMT2Ar acute leukemia.
The FDA set a new action date of December 26, 2024, providing additional time to review supplemental information submitted by Syndax. The company's CEO, Michael A. Metzger, has expressed confidence in the data supporting revumenib's approval, citing the AUGMENT-101 trial results.
InvestingPro Insights
As Syndax Pharmaceuticals (NASDAQ:SNDX) anticipates the FDA's decision on their drug candidate, revumenib, investors seeking to gauge the company's financial health and future prospects can find valuable insights through InvestingPro's real-time metrics and tips. With a market capitalization of $1.85 billion and a challenging P/E ratio of -6.61, reflecting a market that is not expecting profitability in the short term, Syndax's financial position is a critical element for investors to consider. The company's balance sheet strength is highlighted by the fact that it holds more cash than debt, an InvestingPro Tip that suggests a level of financial stability despite the current lack of profitability.
Positive momentum is noted with analysts revising earnings upwards for the upcoming period and the stock's strong return over the last month, three months, and five years. Nevertheless, the company is not without its challenges; it suffers from weak gross profit margins and net income is expected to drop this year. These factors are essential for investors to weigh, especially as the company does not pay dividends, redirecting potential investor returns into the business for growth or to shore up its financial position.
For those looking to delve deeper into Syndax's financial nuances and future outlook, InvestingPro provides additional tips, including insights on liquid assets exceeding short-term obligations and the company's performance over the last twelve months. There are 10 more InvestingPro Tips available for Syndax, offering a comprehensive perspective on the company's financial health and market potential. Interested readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription to access these insights and more.
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