On Wednesday, Syndax Pharmaceuticals (NASDAQ:SNDX) shares retained Buy rating and $36.00 price target from B.Riley, in light of the anticipated significant developments for the company. The focus is on two upcoming catalysts: the pivotal data readout for revumenib in NPM1m AML and the expected FDA approval for KMT2Ar leukemias, both set for December 26.
The firm projects that positive results from these events could lead to a 30%-60% appreciation in Syndax's share price from current levels. Specifically, for the treatment of NPM1m AML, expectations are set for Syndax to achieve a 25%-30% complete response (CR/CRh) rate, with a median response duration of about six months.
Additionally, the analyst estimates an 85% probability of the FDA granting approval for revumenib in treating KMT2Ar leukemias by the end of the year. This high likelihood of regulatory nod is a key element in the firm's positive outlook for the stock.
Despite a recent dip in performance, where SNDX shares have declined by 20% over the past six months in contrast to a 7% increase in the XBI biotech index, the firm views the current situation as an advantageous buying opportunity for investors. The maintained Buy rating and price target reflect a confidence in Syndax's potential for significant growth pending the outcomes of the upcoming catalysts.
The analyst's support for the stock is based on the expected milestones, which are seen as pivotal moments for Syndax Pharmaceuticals. The company's progress and potential FDA approval are anticipated to be key drivers for the stock's future performance.
In other recent news, Syndax Pharmaceuticals has seen significant developments. The company's drug Niktimvo, developed in partnership with Incyte (NASDAQ:INCY), received FDA approval for the treatment of chronic graft-versus-host disease. This approval led H.C. Wainwright to increase its price target on Syndax shares, maintaining a Buy rating. TD Cowen also reiterated a Buy rating following the FDA nod. The launch of Niktimvo is expected in late 2024, with projected sales reaching $5 million for the year, and potentially growing to $173 million by 2029.
In addition to Niktimvo, Syndax's drug Revumenib, targeting acute leukemia, demonstrated positive outcomes in the AUGMENT-101 trial. The FDA granted Priority Review status for Revumenib, with an action date set for late 2024. Syndax is preparing for a potential commercial launch, anticipating FDA approval.
On the financial front, Syndax outlined a robust Q2 2024 outlook during its recent earnings call, indicating strong financial health with $455 million in cash reserves. These reserves are expected to support upcoming product launches and clinical trials. These are some of the recent developments concerning Syndax Pharmaceuticals.
InvestingPro Insights
To complement the analysis of Syndax Pharmaceuticals (NASDAQ:SNDX) and its upcoming catalysts, InvestingPro data offers additional context for investors. Despite the company's recent share price decline, InvestingPro Tips highlight that SNDX has shown a strong return over the last five years, indicating long-term resilience.
However, it is important to note that SNDX is not currently profitable, with a negative P/E ratio of -5.92 over the last twelve months as of Q2 2024. This aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year. The company's revenue for the same period stands at $3.5 million, with a market capitalization of $1.56 billion, suggesting a high revenue valuation multiple.
On a positive note, 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 awaits the pivotal data readout and potential FDA approval.
For investors considering SNDX's potential, InvestingPro offers 9 additional tips that could provide further insights into the company's financial health and market position. These tips, along with real-time metrics, can help in making more informed investment decisions as Syndax approaches its critical milestones.
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