On Monday, H.C. Wainwright maintained a Buy rating for Kura Oncology (NASDAQ:KURA) with a steadfast price target of $32.00. This affirmation follows the recent FDA approval of Syndax Pharmaceuticals (NASDAQ:SNDX)' Revuforj (revumenib) on Friday. The new drug, a menin inhibitor, is designed to treat relapsed/refractory (r/r) acute myeloid leukemia (AML) patients with KMT2A rearrangements, a condition present in roughly 10% of AML cases. The approval is considered a significant advancement for this patient group.
Revuforj's approval is particularly noteworthy as it addresses the needs of a defined molecular and genetic subgroup within the AML patient population. This group, combined with NPM1 mutation-positive (NPM1-m) patients, who make up about 30% of AML cases, has been in urgent need of innovative treatment options. Kura Oncology's ziftomenib is also undergoing clinical trials targeting the same NPM1-m r/r AML patient group.
The analyst highlighted that while Revuforj has shown consistent efficacy in treating both NPM1-m and KMT2Ar AML patients, initial results from ziftomenib trials suggest it may offer similar efficacy with better tolerability compared to Revuforj, particularly in the NPM1-m population. These observations are based on preliminary data from ongoing studies, including the AUGMENT-101 and KOMET-001 trials.
The AUGMENT-101 study addressed issues related to differentiation syndrome (DS) and QTc prolongation, and the KOMET-001 trial, which recently completed enrollment with 85 participants, is expected to release results in the first quarter of 2025. The anticipation surrounding the outcomes of these trials is high, as they could potentially lead to the development of new menin inhibitors for treating r/r AML populations.
The analyst expressed enthusiasm for the potential of Revuforj to set a precedent for the introduction of novel treatments in this therapeutic area and is looking forward to further developments regarding both Revuforj and ziftomenib in treating NPM1-m patients. The reiterated Buy rating and price target reflect confidence in the ongoing progress and future prospects of Kura Oncology's pipeline.
In other recent news, Kura Oncology has reported significant progress in its clinical programs, with a notable emphasis on the menin inhibitor ziftomenib, showing potential in treating acute myeloid leukemia (AML). Despite a rise in R&D expenses to $41.7 million and a net loss of $54.4 million in Q3 2024, the company's cash and short-term investments total $455.3 million, which is projected to fund operations into 2027.
The company is set to present preliminary data for various clinical trials at the American Society of Hematology meeting and is planning to initiate pivotal studies for ziftomenib by mid-2024 with an NDA filing expected by late 2024.
Additionally, Kura Oncology is advancing trials for other therapies, including KO-2806 and tipifarnib. The company also plans to nominate a next-generation menin inhibitor candidate for diabetes in the first half of 2025. These are recent developments that point to Kura Oncology's continued focus on innovation in the field of oncology. With strong retention and response rates in frontline therapy trials for AML and positive safety profile trends, the company is making significant strides in its mission to bring new treatments to patients with critical needs.
InvestingPro Insights
Recent InvestingPro data provides additional context to Kura Oncology's (NASDAQ:KURA) financial position and market performance. Despite the company's promising pipeline and the analyst's optimistic outlook, it's important to note that Kura is not currently profitable, with a negative operating income of $217.5 million over the last twelve months as of Q3 2023. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
However, Kura's financial stability is bolstered by the fact that it holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. This strong liquidity position could be crucial for supporting ongoing clinical trials and potential commercialization efforts for ziftomenib.
The stock has demonstrated significant volatility, with a 66.53% price return over the past year, despite a recent 9.34% decline in the last week. This performance reflects both the potential upside of Kura's oncology pipeline and the inherent risks associated with clinical-stage biopharmaceutical companies.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide deeper insights into Kura Oncology's investment potential.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.