Latest news with #Kura
Yahoo
02-06-2025
- Business
- Yahoo
Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML
– New Drug Application based on positive results from the Phase 2 KOMET-001 trial – – FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025 – – Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, 'Kura') and Kyowa Kirin Co., Ltd. (TSE: 4151, 'Kyowa Kirin') today announced the U.S. Food and Drug Administration (FDA) has accepted Kura'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. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025. 'The FDA's acceptance of our New Drug Application marks a significant milestone for Kura and Kyowa Kirin and, more importantly, for patients living with this genetic subset of AML, who face an aggressive form of the disease with few treatment options,' said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. 'This achievement reflects the strength of the clinical data for ziftomenib as well as the incredible commitment of our teams. Along with our partners at Kyowa Kirin, we look forward to continuing to work closely with the FDA throughout the review process and to prepare for the anticipated launch of this treatment, which holds potential to meaningfully impact the lives of patients and their families.' The NDA is based on results from the Phase 2 KOMET-001 registrational trial in R/R NPM1-mutant (NPM1-m) AML (NCT #04067336). The KOMET-001 trial achieved its primary endpoint of complete remission (CR) plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. Ziftomenib was well‑tolerated with limited myelosuppression and 3% ziftomenib-related discontinuations. The safety and tolerability of ziftomenib were consistent with previous reports, and the benefit-risk profile for ziftomenib is highly encouraging. 'Adult R/R NPM1-m AML patients face a significantly poor prognosis, highlighting the urgent need for innovative treatment options that can improve their outcomes,' said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. 'The acceptance of this NDA is a crucial step in our ongoing efforts to explore and evaluate various therapeutic strategies for AML through our comprehensive clinical trials. Our dedicated teams at Kyowa Kirin and Kura are fully committed to working tirelessly to ensure that, once approved, ziftomenib is made available to AML patients as quickly as possible. We recognize the importance of this endeavor and are excited about the possibility of making a meaningful impact on the lives of those affected by this challenging disease.' The KOMET-001 registration-directed trial is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib, the only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the FDA for treatment of R/R NPM1-mutant AML. In addition to BTD, ziftomenib has received Fast Track and Orphan Drug Designations. The full data analyses from the KOMET-001 trial of ziftomenib in R/R NPM1-m AML patients have been selected for oral presentation on Monday, June 2nd at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and an encore presentation is planned at the 2025 European Hematology Association (EHA) Congress. About -Mutant AML AML is the most common acute leukemia in adults and begins when the bone marrow makes abnormal myeloblasts (white blood cells), red blood cells or platelets. Despite the many available treatments for AML, prognosis for patients remains poor and a high unmet need remains. The menin pathway is considered a driver for multiple genetic alterations of the disease, of which NPM1 mutations are among the most common, representing approximately 30% of AML cases. While patients with NPM1-m AML have high response rates to frontline therapy, relapse rates are high and survival outcomes are poor, with only 30% overall survival at 12 months in the R/R setting. Additionally, NPM1 mutations frequently occur with co-mutations in other disease-associated genes, including FLT3, DNMT3A, and IDH1/2, with prognosis heavily influenced by the presence of such co-occurring mutations. Adult patients with NPM1-m AML and select co-mutations and/or R/R disease have a poor prognosis, with median overall survival of only approximately 7.8 months in 2nd line, 5.3 months in 3rd line, and 3.5 months following the 4th line1. There are currently no FDA-approved therapies targeting NPM1-m AML. About Ziftomenib Ziftomenib is a potent and selective, oral, investigational menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received BTD from the FDA for the treatment of adult patients with R/R AML with an NPM1 mutation based on data from Kura's KOMET-001 clinical trial. Additional information about clinical trials for ziftomenib can be found at About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin to develop and commercialize ziftomenib, a menin inhibitor, for AML and other hematologic malignancies. Enrollment in KOMET-001, a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML, has been completed, and in the second quarter of 2025, the companies announced submission of an NDA for ziftomenib for the treatment of adult patients with R/R NPM1-m AML. Kura and Kyowa Kirin are conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor (FTI), is being evaluated in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at and follow us on X and LinkedIn. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin's values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at Kura Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib; the potential for ziftomenib to obtain FDA approval for the treatment of patients with NPM1-m AML, and the anticipated timing of such FDA approval; and the potential launch of ziftomenib. Factors that may cause actual results to differ materially from those indicated by these forward-looking statements include the risk that Kura may not be able to successfully demonstrate the safety and/or efficacy of its product candidates, including ziftomenib; the risk that Kura may not obtain approval to market its product candidates, including ziftomenib, or that such approval may be delayed; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words 'may,' 'will,' 'would,' 'could,' 'should,' 'believes,' 'estimates,' 'projects,' 'promise,' 'potential,' 'expects,' 'plans,' 'anticipates,' 'intends,' 'continues,' 'designed,' 'goal,' or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Kura Contacts Investors: Patti Bank Managing Director(415) Media:media@ Kyowa Kirin Contacts Investors: Ryohei Kawaiir@ Media, Global:Wataru Suzuki media@ in to access your portfolio
Scoop
25-05-2025
- Politics
- Scoop
Budget 2025: Māori Educators Say Boost Won't Fix Poor School Buildings
Mori Medium schools received funding in the Budget for approximately 50 new teaching spaces. Kura Kaupapa Māori say Budget 2025 will fail to address their longstanding concerns around substandard school properties. Māori Medium schools received funding in the Budget for approximately 50 new teaching spaces. Te Rūnanga Nui o Ngā Kura Kaupapa Māori o Aotearoa said at present, close to 40 Kura Kaupapa Māori remain on the Ministry of Education's property backlog list. Co-chair of Te Rūnanga Nui Rāwiri Wright said dividing this limited funding across all Māori-medium settings – including Māori immersion units in mainstream schools – will leave kura with next to nothing. 'We are being kept in the dark. There is no clear breakdown of how this funding will be allocated, no equity in the process, and certainly no commitment to a genuine Treaty-based partnership. Meanwhile, our whānau continue to send their tamariki to kura that are falling apart. 'This is not a genuine solution. It's yet another example of the Crown's ongoing failure to prioritise Kura Kaupapa Māori,' Wright said. Te Rūnanga Nui called on the government to implement a long-term, ring-fenced investment plan of $1.25 billion over five years – $250 million annually – dedicated to Kura Kaupapa Māori property development. Over the past five years, the Ministry of Education has allocated less than 3 percent of its property budget to Kura Kaupapa, highlighting a significant underinvestment in this area, Te Rūnanga said in a statement. 'Te Aho Matua defines our kura. Our buildings must reflect the values, identity, and excellence of our tamariki,' Wright said. Chief executive Hohepa Campbell said this is why Kura Kaupapa Māori lodged an urgent claim with the Waitangi Tribunal. 'The Tribunal has since confirmed what we have been saying for years-that the Crown has systematically underinvested in our kura and failed to implement dedicated policy or adequate funding to support our kaupapa,' he said. During the hearings for the claim, Tribunal members visited Te Kura Kaupapa Māori o Ngā Mokopuna in Wellington and were visibly shocked at the substandard facilities tamariki are expected to learn in, Campbell said. In its closing arguments, even the Crown acknowledged that kura are under-resourced and that historical issues demand significant investment. The report found the Crown had breached Te Tiriti o Waitangi by failing to develop bespoke policies and investment strategies to address the specific needs of Kura Kaupapa Māori. Māori Education Package The Budget set aside more than $36 million over four years for a Māori Education Package, which included funding for five components: Training and support for up to 51,000 teachers in Year 0-13 schools to learn te reo Māori and tikanga. A Virtual Learning Network for online STEM education to more than 5500 Year 9-13 students in Kura Kaupapa and Maori Medium education. Seven new curriculum advisors to help teachers in using the redesigned Te Marautanga o Aotearoa. New curriculum resources in te reo matatini and STEM for around 5000 senior secondary students. Developing a new Māori Studies subject area for The New Zealand Curriculum, for Year 11-13 English medium schools. However, this package was funded by reprioritising funding from other initiatives, including disestablishing the Wharekura Expert Teachers programme and disestablishing roles for Resource Teachers of Māori, among other repriorritised funding initiatives. Te Rūnanga Nui said they were appalled by the funding cut to expert wharekura teachers. 'This decision undermines the very heart of quality wharekura secondary education. Our tamariki deserve access to specialist teachers who can provide high-level Te Aho Matua and NCEA curriculum expertise. Cutting this support is not only shortsighted – it is negligent,' their statement read. Education Minister Erica Stanford said the wider investment in education is the most significant investment in learning support in a generation. 'Backed by a social investment lens, this is a seismic shift in how we support learning needs in New Zealand. We're deliberately prioritising early intervention, investing in what works and directly tackling long-standing inequities in the system.'
Scoop
25-05-2025
- Politics
- Scoop
Budget 2025: Māori Educators Say Boost Won't Fix Poor School Buildings
Kura Kaupapa Māori say Budget 2025 will fail to address their longstanding concerns around substandard school properties. Māori Medium schools received funding in the Budget for approximately 50 new teaching spaces. Te Rūnanga Nui o Ngā Kura Kaupapa Māori o Aotearoa said at present, close to 40 Kura Kaupapa Māori remain on the Ministry of Education's property backlog list. Co-chair of Te Rūnanga Nui Rāwiri Wright said dividing this limited funding across all Māori-medium settings - including Māori immersion units in mainstream schools - will leave kura with next to nothing. "We are being kept in the dark. There is no clear breakdown of how this funding will be allocated, no equity in the process, and certainly no commitment to a genuine Treaty-based partnership. Meanwhile, our whānau continue to send their tamariki to kura that are falling apart. "This is not a genuine solution. It's yet another example of the Crown's ongoing failure to prioritise Kura Kaupapa Māori," Wright said. Te Rūnanga Nui called on the government to implement a long-term, ring-fenced investment plan of $1.25 billion over five years - $250 million annually - dedicated to Kura Kaupapa Māori property development. Over the past five years, the Ministry of Education has allocated less than 3 percent of its property budget to Kura Kaupapa, highlighting a significant underinvestment in this area, Te Rūnanga said in a statement. "Te Aho Matua defines our kura. Our buildings must reflect the values, identity, and excellence of our tamariki," Wright said. Chief executive Hohepa Campbell said this is why Kura Kaupapa Māori lodged an urgent claim with the Waitangi Tribunal. "The Tribunal has since confirmed what we have been saying for years-that the Crown has systematically underinvested in our kura and failed to implement dedicated policy or adequate funding to support our kaupapa," he said. During the hearings for the claim, Tribunal members visited Te Kura Kaupapa Māori o Ngā Mokopuna in Wellington and were visibly shocked at the substandard facilities tamariki are expected to learn in, Campbell said. In its closing arguments, even the Crown acknowledged that kura are under-resourced and that historical issues demand significant investment. The report found the Crown had breached Te Tiriti o Waitangi by failing to develop bespoke policies and investment strategies to address the specific needs of Kura Kaupapa Māori. Māori Education Package The Budget set aside more than $36 million over four years for a Māori Education Package, which included funding for five components: Training and support for up to 51,000 teachers in Year 0-13 schools to learn te reo Māori and tikanga. A Virtual Learning Network for online STEM education to more than 5500 Year 9-13 students in Kura Kaupapa and Maori Medium education. Seven new curriculum advisors to help teachers in using the redesigned Te Marautanga o Aotearoa. New curriculum resources in te reo matatini and STEM for around 5000 senior secondary students. Developing a new Māori Studies subject area for The New Zealand Curriculum, for Year 11-13 English medium schools. However, this package was funded by reprioritising funding from other initiatives, including disestablishing the Wharekura Expert Teachers programme and disestablishing roles for Resource Teachers of Māori, among other repriorritised funding initiatives. Te Rūnanga Nui said they were appalled by the funding cut to expert wharekura teachers. "This decision undermines the very heart of quality wharekura secondary education. Our tamariki deserve access to specialist teachers who can provide high-level Te Aho Matua and NCEA curriculum expertise. Cutting this support is not only shortsighted - it is negligent," their statement read. Education Minister Erica Stanford said the wider investment in education is the most significant investment in learning support in a generation. "Backed by a social investment lens, this is a seismic shift in how we support learning needs in New Zealand. We're deliberately prioritising early intervention, investing in what works and directly tackling long-standing inequities in the system."
Forbes
21-04-2025
- Business
- Forbes
Small Startups Are Fueling Stablecoin's Engine
Kura CEO Stephanie Joseph and COO Clifford Nau The vibrant, booming stablecoin sector comprises of visionary Small and medium-sized enterprises that are tackling significant challenges within the current payments infrastructure. Yet, they are to a large extent eclipsed by a handful of large players, such as Circle and Tether, which are center stage in the current Washington legislative debate. The bills advancing in both chambers of Congress focus on standards for issuance, liabilities, disclosures, guardrails. Specifically licensing requirements, guidelines for guaranteeing reserves, consumer rights, and others related matters. Innovation is already fostering growth. The benefits towards a U.S. digital dollar were deliberated over the last five years and policymakers are finally on the cusp of implementing rules pertaining to federal, state, and foreign-issued coins used by Americans. Ben Milne, CEO, Brale Stablecoins, decentralized tokens pegged to an asset like the U.S. dollar, already make up a robust global market, valued at over $220 billion according to Forbes. And the industry is being fueled by small builders all over the world, including in America. Some startups facilitate creation, others power the system. 'Fintechs and financial institutions worldwide are waking up to the idea of introducing protocols and stablecoins into their tech stacks to increase efficiency and revenue,' Brale Founder Ben Milne recently shared during Fintech Meetup in March. His state-regulated firm helps entities create and integrate stablecoins into their business. Milne, who serves on the Commodity Futures Trading Commission Technology Advisory Committee, boasts about the ease of anyone being able to design a stablecoin in just five steps using his company. There is broad optimism about the ways that stablecoins are bridging the gap between decentralized and centralized finance. 'Kura is using USDC to make immense progress toward driving down the cost of remittances, while increasing utility by enabling beneficiaries to spend these digital dollars in the real economy. Their cross-border payment solution enables instant settlement for merchants, instant spending for beneficiaries and transparency on all transactions through point-of-sale data,' Circle, the largest stablecoin issuer in the United States, cited in a recent report. A woman walks past signs advertising cryptocurrency banking at Union Station in Washington, DC, on ... More March 16, 2023. (Photo by Andrew Caballero-Reynolds / AFP) (Photo by ANDREW CABALLERO-REYNOLDS/AFP via Getty Images) Kura was a finalist in Circle's Unlocking Impact pitch competition in Washington, DC last year. Founded by Harvard and MIT scholars Stephanie Joseph and Clifford Nau, the US-based startup provides an alternative method for merchants in the Caribbean and Central America to capture cross-border payments. 'Traditional payment and banking rails no longer suit our digitally-connected world. We leverage blockchain technology to execute near-instant transfers of value across borders while mitigating fraud for merchants at the points of sale. Leveraging stablecoins as a payment utility for cross-border transactions offers the advantage of enabling secure, transparent, and near-instantaneous transactions, reducing costs associated with currency conversions and settlement times,' Joseph and Nau told me in a statement. Other stablecoin founders like Seree CEO Lance Davis are monitoring Washington's progress towards getting a bill across the finish line. The Senate is expected to schedule a vote on the Guiding and Establishing National Innovation for U.S. Stablecoins (GENIUS) Act shortly after Congress is back in session next week. New capital investments are flowing into the exploding marketplace, and micro enterprises and large companies alike are getting ready for the next stage of growth once a reconciled bill is signed into law later this year.
Yahoo
31-03-2025
- Business
- Yahoo
Unpacking Q4 Earnings: Kura Sushi (NASDAQ:KRUS) In The Context Of Other Sit-Down Dining Stocks
Quarterly earnings results are a good time to check in on a company's progress, especially compared to its peers in the same sector. Today we are looking at Kura Sushi (NASDAQ:KRUS) and the best and worst performers in the sit-down dining industry. Sit-down restaurants offer a complete dining experience with table service. These establishments span various cuisines and are renowned for their warm hospitality and welcoming ambiance, making them perfect for family gatherings, special occasions, or simply unwinding. Their extensive menus range from appetizers to indulgent desserts and wines and cocktails. This space is extremely fragmented and competition includes everything from publicly-traded companies owning multiple chains to single-location mom-and-pop restaurants. The 13 sit-down dining stocks we track reported a satisfactory Q4. As a group, revenues beat analysts' consensus estimates by 0.9% while next quarter's revenue guidance was 2.4% below. Amidst this news, share prices of the companies have had a rough stretch. On average, they are down 13% since the latest earnings results. Known for its conveyor belt that transports dishes to diners, Kura Sushi (NASDAQ:KRUS) is a chain of sushi restaurants serving traditional Japanese fare with a touch of modernity and technology. Kura Sushi reported revenues of $64.46 million, up 25.2% year on year. This print exceeded analysts' expectations by 4.7%. Overall, it was an exceptional quarter for the company with an impressive beat of analysts' EPS estimates and a solid beat of analysts' EBITDA estimates. Hajime Uba, President and Chief Executive Officer of Kura Sushi, stated, 'Our fiscal year is off to an excellent start, and we're very encouraged to see that our comps have returned to positive territory. Our new openings are exceeding expectations and have us even more excited about Kura's ultimate opportunity in the U.S. Adjusted EBITDA margins have achieved an all-time high for a fiscal first quarter, thanks to companywide efforts to control costs. We're off to a great start, and I'm extremely excited for another banner year at Kura Sushi.' The stock is down 50% since reporting and currently trades at $50.97. Is now the time to buy Kura Sushi? Access our full analysis of the earnings results here, it's free. Founded by Norman Brinker in Dallas, Brinker International (NYSE:EAT) is a casual restaurant chain that operates the Chili's, Maggiano's Little Italy, and It's Just Wings banners. Brinker International reported revenues of $1.36 billion, up 26.5% year on year, outperforming analysts' expectations by 9.6%. The business had an incredible quarter with an impressive beat of analysts' EPS estimates and a solid beat of analysts' EBITDA estimates. Brinker International achieved the biggest analyst estimates beat and highest full-year guidance raise among its peers. Although it had a fine quarter compared to its peers, the market seems unhappy with the results as the stock is down 6.1% since reporting. It currently trades at $145.20. Is now the time to buy Brinker International? Access our full analysis of the earnings results here, it's free. Owner of the iconic Australian-themed Outback Steakhouse, Bloomin' Brands (NASDAQ:BLMN) is a leading American restaurant company that owns and operates a portfolio of popular restaurant brands. Bloomin' Brands reported revenues of $972 million, down 18.6% year on year, falling short of analysts' expectations by 9.9%. It was a disappointing quarter as it posted full-year EPS guidance missing analysts' expectations. Bloomin' Brands delivered the weakest performance against analyst estimates and slowest revenue growth in the group. As expected, the stock is down 38.2% since the results and currently trades at $7.35. Read our full analysis of Bloomin' Brands's results here. Celebrated for its delicious (and free) brown bread, gigantic portions, and delectable desserts, Cheesecake Factory (NASDAQ:CAKE) is an iconic American restaurant chain that also owns and operates a portfolio of separate restaurant brands. The Cheesecake Factory reported revenues of $921 million, up 5% year on year. This print topped analysts' expectations by 0.9%. It was a strong quarter as it also produced a solid beat of analysts' EBITDA estimates and a decent beat of analysts' EPS estimates. The stock is down 10.6% since reporting and currently trades at $48.53. Read our full, actionable report on The Cheesecake Factory here, it's free. Founded in 1968 as Red Lobster, Darden (NYSE:DRI) is a leading American restaurant company that owns and operates a portfolio of popular restaurant brands. Darden reported revenues of $3.16 billion, up 6.2% year on year. This result missed analysts' expectations by 1.7%. Overall, it was a slower quarter as it also logged a slight miss of analysts' same-store sales estimates. The stock is up 8.7% since reporting and currently trades at $204.61. Read our full, actionable report on Darden here, it's free. Want to invest in winners with rock-solid fundamentals? Check out our Hidden Gem Stocks and add them to your watchlist. These companies are poised for growth regardless of the political or macroeconomic climate. Join Paid Stock Investor Research Help us make StockStory more helpful to investors like yourself. Join our paid user research session and receive a $50 Amazon gift card for your opinions. Sign up here. Sign in to access your portfolio
