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On Tuesday, Cantor Fitzgerald analysts reiterated an Overweight rating for Kura Oncology stock (NASDAQ: NASDAQ:KURA), which has seen a notable 12.3% gain over the past week despite being down 70% year-over-year. The reaffirmation follows the analyst’s attendance at the ziftomenib oral presentation during the ASCO event and subsequent discussions with the company’s management. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt.
The analysts highlighted the upcoming PDUFA date set for November 30, 2025, as a significant milestone for ziftomenib. They noted that the focus has shifted towards market adoption in relapsed/refractory NPM1 AML compared to revumenib, as well as potential combinations in first-line treatment. With 5 analysts recently revising their earnings estimates upward, market sentiment appears increasingly positive.
Ziftomenib and revumenib reportedly show similar efficacy in second-line treatment, with further evaluation needed for first-line applications. However, ziftomenib’s advantages in dosing, safety, and possibly therapy duration could enhance its market presence.
The potential market opportunity for ziftomenib in the relapsed/refractory segment is estimated to be modest, ranging from $350 million to $400 million, according to company guidance. The analysts also mentioned insights from the ASCO monotherapy update related to safety, minimal residual disease negativity, and overall survival in first-line combinations. Based on InvestingPro’s Fair Value analysis, the stock currently appears undervalued. Discover more insights and 8 additional ProTips in the comprehensive Pro Research Report, available exclusively to subscribers.
In other recent news, Kura Oncology reported a significant increase in revenue for the first quarter of 2025, reaching $14.1 million compared to zero in the same quarter last year. Despite this revenue boost, the company’s earnings per share (EPS) came in at -$0.66, slightly missing the forecast of -$0.62. Kura Oncology, in collaboration with Kyowa Kirin, announced positive trial results for their investigational drug, ziftomenib, aimed at treating relapsed or refractory NPM1-mutant acute myeloid leukemia (AML). The Phase 2 KOMET-001 trial showed a 23% complete remission rate, with a favorable safety profile and limited adverse events. H.C. Wainwright reaffirmed its Buy rating for Kura Oncology, highlighting the FDA’s acceptance of the New Drug Application for ziftomenib, which has been granted Priority Review. Cantor Fitzgerald also maintained its Overweight rating, noting the promising safety profile of ziftomenib compared to competitors. These developments indicate Kura Oncology’s continued progress in advancing its oncology pipeline and preparing for potential commercialization efforts.
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