Wednesday, Stifel financial firm increased its price target for Syndax Pharmaceuticals (NASDAQ:SNDX) shares to $42.00, up from the previous $40.00, while maintaining a Buy rating on the stock. The adjustment comes as Syndax anticipates an early approval for its drug Revumenib, used for treating relapsed/refractory (R/R) KMT2Ar leukemia, which has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for September 26, 2024.
Syndax is reportedly prepared for an immediate launch of Revumenib, as historical data shows that most drugs under the Real-Time Oncology Review (RTOR) program receive approval at least one month ahead of schedule. The company's management has indicated their readiness for a third-quarter product launch, hinting at potential availability in July or August.
Revumenib's position as a first-mover in the market for acute myeloid leukemia (AML) treatments is seen as crucial, especially with the presence of competing menin inhibitors still in clinical trials. Syndax's strategy aims to capture a significant market share and establish a dominant presence in the AML space.
Additionally, Syndax is progressing towards a fourth-quarter 2024 readout of pivotal data for its R/R NPM1m AML treatment, with expectations pointing towards a late October or early November timeline. If the pivotal data is favorable, this could pave the way for a mid-2025 approval, assuming efficient filing processes.
Syndax's anticipation of early off-label use by key opinion leaders in the AML community, coupled with the importance of National Comprehensive Cancer Network (LON:NETW) (NCCN) Guidelines, has been factored into Stifel's updated market model, leading to the new $42.00 price target. This reflects the firm's confidence in Syndax's strategic positioning and the potential market impact of its upcoming drug approvals.
In other recent news, Syndax Pharmaceuticals reported encouraging results from its acute leukemia drug candidate, revumenib, during trials. The company also outlined a robust Q1 2024 performance, reporting a strong cash position of $522 million, expected to last through 2026. Analysts from firms such as Barclays (LON:BARC) Capital Inc. and JPMorgan (NYSE:JPM) have consistently rated the company as "Overweight", despite negative earnings per share forecasts.
In addition, Syndax Pharmaceuticals and Pyxis Oncology have announced significant additions to their respective boards. Syndax welcomed Aleksandra Rizo, M.D., Ph.D., an expert in hematology drugs, while Pyxis appointed Michael A. Metzger, the current CEO of Syndax.
These recent developments reflect Syndax's strategic transition to a commercial-stage organization and its continued commitment to advancing its drug pipeline. The company is preparing for the expected near-term approval of revumenib, with plans to initiate a pivotal trial by the end of 2024. As these developments unfold, Syndax remains a notable player in the biotechnology industry, especially with its work on revumenib, which shows significant potential in treating various cancers.
InvestingPro Insights
As Syndax Pharmaceuticals (NASDAQ:SNDX) gears up for the anticipated early approval and launch of its leukemia drug, Revumenib, the financial metrics and analyst insights from InvestingPro provide a deeper look into the company's market stance. With a market capitalization of $1.66 billion, the company's financial health is underscored by the fact that it holds more cash than debt on its balance sheet, a reassuring signal for investors considering the company's growth prospects.
InvestingPro Tips reveal that Syndax has received upward earnings revisions from 8 analysts for the upcoming period, reflecting a positive outlook on the company's revenue potential following the drug launch. Additionally, the company's liquid assets surpass its short-term obligations, suggesting a solid position to manage upcoming operational needs. However, it's important to note that Syndax is not expected to be profitable this year, and it has not been profitable over the last twelve months, indicating the high-stakes nature of the Revumenib launch for the company's financial turnaround.
To gain further insights and additional InvestingPro Tips, which currently number 9 for Syndax, investors can visit InvestingPro. For those looking to delve deeper into these metrics, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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