On Thursday, UBS began covering Syndax Pharmaceuticals (NASDAQ:SNDX), issuing a Buy rating and setting a price target of $37.00 for the company's stock. The coverage comes with a positive outlook on the company's leading drug, revumenib, citing its potential as a first-to-market menin inhibitor.
The UBS analyst highlighted the expected approval of revumenib for the treatment of relapsed/refractory (R/R) KMT2Ar acute myeloid leukemia (AML) by December 26, 2024. Their optimism is based on several factors, including the drug's first-to-market advantage, its superior clinical profile compared to competitors for treating KMT2Ar AML, and the significant unmet needs in this area.
The report also points to several near-term catalysts that could increase Syndax's stock value. These include pivotal data for revumenib in R/R NPM1m AML expected in the fourth quarter of 2024, with potential approval following in 2025. Additionally, the initiation of a pivotal trial in frontline (1L) AML is anticipated by the end of 2024, along with updates on combination data in 2024 and 2025.
In terms of sales expectations, UBS projects that revumenib could achieve approximately $1.7 billion in risk-adjusted peak sales, which surpasses the consensus estimate of around $1 billion. Without adjusting for risk, the peak sales projection climbs to roughly $2.6 billion. The report underscores the firm's high conviction in the market opportunity for revumenib in the treatment of acute leukemias.
In other recent news, Syndax Pharmaceuticals has reported significant developments with its two key drug candidates, Revumenib and Niktimvo. B.Riley has maintained a Buy rating on Syndax, highlighting the potential FDA approval for Revumenib in treating KMT2Ar leukemias. Positive results from the AUGMENT-101 trial for Revumenib were published in the Journal of Clinical Oncology, indicating a complete remission rate of 23% among the patients evaluated for efficacy.
On the other hand, Niktimvo, developed in partnership with Incyte (NASDAQ:INCY), received FDA approval for the treatment of chronic graft-versus-host disease, leading H.C. Wainwright to increase its price target on Syndax shares. The company also reported 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.
TD Cowen reiterated a Buy rating following the FDA approval of Niktimvo, reflecting confidence in the company's growth potential. The launch of Niktimvo is expected in late 2024, with projected sales reaching $5 million for the year, potentially growing to $173 million by 2029. These are the recent developments in Syndax Pharmaceuticals.
InvestingPro Insights
To complement UBS's optimistic outlook on Syndax Pharmaceuticals (NASDAQ:SNDX), recent data from InvestingPro offers additional context for investors. Despite the company's promising drug pipeline, InvestingPro Tips highlight that Syndax is not currently profitable and is expected to see a drop in net income this year. This aligns with the company's focus on research and development, which is typical for biotechnology firms in the pre-approval stages of drug development.
However, Syndax's financial position appears stable, with InvestingPro data showing a market capitalization of $1.58 billion. An InvestingPro Tip notes that the company "holds more cash than debt on its balance sheet," which is crucial for funding ongoing clinical trials and potential commercialization efforts for revumenib.
Interestingly, despite the current lack of profitability, Syndax has shown strong market performance, with another InvestingPro Tip indicating a "high return over the last year." This suggests investor confidence in the company's future prospects, possibly driven by the potential of revumenib that UBS has highlighted.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide further insights into Syndax's financial health and market position.
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