Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
Kura Oncology, Inc. (KURA)
Last kura oncology, inc. earnings: 2/25 04:03 pm
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Source: GlobeNewswire
SAN DIEGO and TOKYO, April 08, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”), today announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM 1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura expects to receive notification from the FDA on this preliminary evaluation in the second quarter of 2025. Priority Review was requested, which, if granted, would provide a target FDA review period of six months after NDA acceptance. “This NDA submission brings us one step closer to our
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KURA
News
- Kura Oncology and Kyowa Kirin Report Combination Data for KOMZIFTI™ (Ziftomenib) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory AMLGlobeNewswire
- Why The Narrative Around Kura Oncology Is Shifting After Komzifti's FDA Breakthrough [Yahoo! Finance]Yahoo! Finance
- Kura Oncology (NASDAQ:KURA) had its "market outperform" rating reaffirmed by analysts at Citigroup Inc..MarketBeat
- Kura Oncology: A Cautious Buy [Seeking Alpha]Seeking Alpha
- Kura Oncology to Host Virtual Investor Event to Discuss Data Presented at ASH 2025 on Triplet Combination of Ziftomenib (KOMZIFTI®) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia [Yahoo! Finance]Yahoo! Finance
KURA
Earnings
- 11/4/25 - Miss
KURA
Sec Filings
- 12/10/25 - Form 4
- 12/9/25 - Form 144
- 12/2/25 - Form 8-K
- KURA's page on the SEC website