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On Tuesday, H.C. Wainwright reaffirmed its Buy rating and $40.00 price target for Kura Oncology (NASDAQ:KURA) shares. According to InvestingPro data, this target represents significant upside potential from the current price of $6.51, with analyst consensus remaining bullish at 1.47 (Strong Buy). The stock has experienced a challenging period, declining over 62% in the past six months. The firm’s endorsement follows Kura’s announcement on April 28 regarding the progression of its Phase 1 KOMET-015 clinical trial. This trial is significant as it evaluates the combination of ziftomenib with imatinib in advanced gastrointestinal stromal tumor (GIST) patients who have shown disease progression on or after treatment with imatinib.
Gastrointestinal stromal tumors represent the most prevalent form of sarcoma, with an estimated 4,000 to 6,000 new cases identified annually in the U.S. Despite imatinib’s status as the standard of care in frontline GIST treatment, resistance develops in approximately 60% of patients within two years. Alternative treatments have been hampered by limited effectiveness and challenging side effects. Notably, Kura Oncology maintains a strong financial position with more cash than debt and a healthy current ratio of 9.46, providing runway for its clinical development programs. Get deeper insights into Kura’s financial health and 8 additional key ProTips with InvestingPro.
Kura’s approach with ziftomenib, a menin inhibitor, in combination with imatinib, has demonstrated promising preclinical results. The treatment showed potent and lasting anti-tumor effects in both imatinib-sensitive and resistant GIST patient-derived xenograft models. This suggests a potential to either delay or overcome the resistance typically seen with current treatments.
The KOMET-015 trial is the first to examine a menin inhibitor combined with the standard of care in GIST. Following the dose-escalation phase, the study will expand to evaluate the safety and clinical efficacy of ziftomenib more extensively. Primary objectives of the trial include assessing safety, tolerability, and establishing the recommended Phase 2 dose. Secondary endpoints focus on clinical benefit, objective response rate (ORR), progression-free survival (PFS), response duration, and overall survival (OS).
H.C. Wainwright’s maintained rating and price target reflect a continued positive outlook on Kura Oncology’s stock, supported by the potential of its clinical developments in GIST treatment. While the company is not currently profitable, with a loss per share of $2.02 in the last twelve months, InvestingPro’s Fair Value analysis suggests the stock is currently undervalued. Discover comprehensive analysis and detailed metrics in the Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Kura Oncology reported a better-than-expected earnings performance for the fourth quarter of 2024, with an earnings per share of -$0.22, surpassing the forecast of -$0.57. The company also announced significant collaboration revenue amounting to $53.9 million, marking a substantial increase from the previous year. Kura Oncology has maintained its Market Outperform rating and a $28 price target, as confirmed by analysts at JMP Securities, who highlighted the timely submission of a New Drug Application (NDA) for ziftomenib, a treatment for relapsed/refractory NPM1-mutated acute myeloid leukemia (AML).
The NDA submission is a significant milestone for Kura, as ziftomenib has received Breakthrough Therapy Designation from the FDA, which accelerates the development process. Analysts at JMP expressed confidence in Kura’s operational capabilities and the anticipated revenue generation by late 2025 or early 2026. Kura Oncology’s financial health is strong, with a cash reserve of $727.4 million, including $420 million in remaining milestone payments. Additionally, Kura Oncology presented promising preclinical data on KO-2806 at the AACR Annual Meeting, showcasing its potential in treating renal cell carcinoma.
The company’s strategic positioning and research advancements continue to attract attention in the biopharmaceutical sector. Kura is preparing for another NDA submission for its AML treatment in the second quarter of 2025. These developments underscore Kura’s commitment to advancing its pipeline and securing regulatory approvals for its promising drug candidates.
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