On Monday, Syndax Pharmaceuticals (NASDAQ:SNDX) saw its price target increased by H.C. Wainwright from $49.00 to $51.00, while the firm maintained a Buy rating on the stock. This adjustment follows the recent FDA approval of Syndax's Revuforj (revumenib) for the treatment of acute leukemia in both adult and pediatric patients with a specific genetic alteration.
The FDA's endorsement of Revuforj came after the market closed on Friday. Revuforj is recognized as the first and only FDA-approved menin inhibitor, a treatment for patients one year and older with relapsed or refractory acute leukemia that exhibits a KMT2A translocation. The drug had previously been granted Breakthrough Therapy Designation, highlighting its potential as a significant advancement in treatment.
The approval was initially expected by the Prescription Drug User Fee Act (PDUFA) deadline of December 26, 2024. However, the FDA's Real-Time Oncology Review program expedited the process. The agency's decision was based on data from the Phase 1/2 AUGMENT-101 trial, which included an analysis of 104 patients.
Results showed a complete response rate of 21%, with the median duration of response lasting 6.4 months and the median time to achieve a response at 1.9 months. Notably, 23% of the patients were able to proceed to hematopoietic stem cell transplantation after treatment with Revuforj.
H.C. Wainwright's analyst cited the FDA approval and the drug's breakthrough status as key reasons for reiterating the Buy rating and raising the price target for Syndax's shares. The firm's positive outlook reflects the potential market impact of Revuforj as a new treatment option for patients with this challenging form of leukemia.
In other recent news, Syndax Pharmaceuticals has seen significant developments. The company announced positive results from its AUGMENT-101 trial for revumenib, a treatment for acute myeloid leukemia (AML).
The trial met its primary endpoint with a 23% complete response rate among evaluable adults. In financial developments, Syndax announced a substantial $350 million royalty agreement with Royalty Pharma for Niktimvo during its Q3 2024 earnings call. The company reported $399.6 million in cash as of September 30, with Q3 operating expenses at $102.1 million.
Analyst firms have also adjusted their outlooks on Syndax. Scotiabank (TSX:BNS) reduced its price target for the company to $18 due to potential FDA approval risks for revumenib. However, H.C. Wainwright raised its price target to $49, maintaining a Buy rating, following positive results from the AUGMENT-101 trial. Goldman Sachs also adjusted its price target for Syndax, lowering it from $33 to $31, maintaining a Buy rating, due to concerns raised about QTc prolongations and differentiation syndrome in the same trial.
InvestingPro Insights
Recent InvestingPro data provides additional context to Syndax Pharmaceuticals' (NASDAQ:SNDX) current financial position and market performance. Despite the positive news of FDA approval for Revuforj and the increased price target from H.C. Wainwright, the company's stock has experienced significant volatility. InvestingPro Tips reveal that SNDX's stock has taken a big hit over the last week, with a 1-week price total return of -27.32%. This short-term decline may present an opportunity for investors who believe in the long-term potential of Revuforj.
It's worth noting that Syndax holds more cash than debt on its balance sheet, which could provide financial flexibility as it moves forward with the commercialization of Revuforj. However, the company is not currently profitable, with a negative gross profit margin and operating income. This is not uncommon for biotech companies in the early stages of bringing a drug to market.
Analysts anticipate that Syndax will not be profitable this year, which aligns with the company's current financial metrics. The market cap stands at $1.35 billion, reflecting investor expectations for future growth. For those interested in a more comprehensive analysis, InvestingPro offers 11 additional tips for SNDX, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.