KURA Stock Rises More Than 15% This Past Week: Here's Why

Shares of Kura Oncology KURA have rallied 15.5% in the past week against the industry’s decline of 0.1%. Earlier this week, the FDA accepted the company’s new drug application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Nov. 30, 2025.Per management, a potential nod would make ziftomenib the first menin inhibitor to be approved for the treatment of R/R NPM1-mutant AML.This can be attributed to the reason for the stock price increase during the aforementioned time.Image Source: Zacks Investment ResearchMore on KURA's Development Activities With ziftomenibThe company’s lead product candidate, ziftomenib, is an investigational oral menin inhibitor, which is being developed for treating genetically defined subsets of acute leukemias, including AML and acute lymphoblastic leukemia.Kura Oncology entered into an agreement with Japan-based pharmaceutical company Kyowa Kirin to develop and commercialize ziftomenib for AML and other hematologic malignancies in November 2024.The NDA for ziftomenib was based on data from the phase II KOMET-001 registrational study. The study met its primary endpoint of complete remission (CR) plus CR with partial blood recovery, and this result was statistically significant. The safety and tolerability of ziftomenib were similar to that seen in previous reports.The NDA was submitted in the second quarter of 2025, which triggered a milestone payment of $45 million for KURA under the company’s agreement with Kyowa Kirin.The FDA has already granted Breakthrough Therapy designation, Fast Track designation and Orphan Drug designation to ziftomenib for the treatment of R/R NPM1-mutant AML.Besides AML, ziftomenib in combination with imatinib is being developed in an early-stage study for the treatment of patients with advanced gastrointestinal stromal tumors after imatinib failure.KURA's Other Pipeline UpdatesThe company is developing its next-generation farnesyl transferase inhibitor (FTI), KO-2806, both as a monotherapy and in combination with other therapies, in an early-stage study for various types of solid tumors.Kura Oncology is also developing another FTI, tipifarnib, in combination with alpelisib in a phase I/II study for patients with PIK3CA-dependent head and neck squamous cell carcinoma.Data from these studies are expected to be presented later in 2025.Ziftomenib is nearing a potential FDA nod and some clinical milestones are expected later in the year. This should help KURA maintain the momentum and drive the stock in 2025.Kura Oncology, Inc. Price Kura Oncology, Inc. price | Kura Oncology, Inc. QuoteKURA's Zacks Rank & Stocks to ConsiderKura Oncology currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector are Amarin AMRN, Lexicon Pharmaceuticals LXRX and Chemomab Therapeutics CMMB, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.00 to $2.78 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $2.04. Year to date, shares of AMRN have rallied 22.2%.AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 2.9%.LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.In the past 60 days, estimates for Chemomab Therapeutics’ loss per share have narrowed from 70 cents to 60 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 80 cents to 70 cents. Year to date, shares of CMMB have declined 27.9%.CMMB’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 5.00%.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is among the most innovative financial firms. With a fast-growing customer base (already 50+ million) and a diverse set of cutting edge solutions, this stock is poised for big gains. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Lexicon Pharmaceuticals, Inc. (LXRX): Free Stock Analysis Report Amarin Corporation PLC (AMRN): Free Stock Analysis Report Kura Oncology, Inc. (KURA): Free Stock Analysis Report Chemomab Therapeutics Ltd. Sponsored ADR (CMMB): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks