Kura Celebrates Major Success with FDA Approval of New Leukemia Medication
FDA Approval: The U.S. FDA has granted full approval to Komzifti (ziftomenib) for treating relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, making it the first oral menin inhibitor approved for this condition.
Clinical Trial Results: The approval is based on the KOMET-001 trial, which showed a 21.4% rate of complete remission (CR) plus CR with partial hematologic recovery (CRh), with a median duration of 5.0 months for these responses.
Strategic Collaboration: Kura Oncology and Kyowa Kirin entered a global collaboration in November 2024 to develop and commercialize Komzifti, with Kura confirming a $30 million milestone payment following the first patient dosing in a Phase 3 study.
Market Performance: Following the news, Kura Oncology's stock rose by 15.07% to $12.29, and Wedbush raised its price target for the company from $36 to $38, reflecting positive market sentiment.
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Kura Oncology Grants Stock Options to New Employees
- Stock Option Grant: On February 2, 2026, Kura Oncology granted 69,750 nonstatutory stock options to four new employees, aimed at attracting and retaining talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Exercise Price Setting: Each stock option has an exercise price of $8.27 per share, matching the closing price on the grant date, which serves to incentivize employees to grow alongside the company.
- Vesting Schedule: The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting monthly, ensuring employee stability during their service with the company.
- Strategic Positioning: Kura Oncology focuses on precision medicine and is committed to developing innovative cancer therapies, particularly with its FDA-approved KOMZIFTI™, demonstrating the company's ongoing commitment to oncology treatment advancements.
Kura Oncology Reports $2.1M KOMZIFTI Revenue in 2025 Financial Results
- Revenue Highlight: Kura Oncology reported $2.1 million in net product revenue from KOMZIFTI (ziftomenib) during the initial five weeks of commercial availability in its preliminary 2025 financial results, indicating strong market acceptance that is expected to drive future revenue growth.
- Milestone Payments: The company received $195 million in milestone payments from its collaboration with Kyowa Kirin in Q4, further strengthening its financial position and providing funding support for ongoing research and development initiatives.
- Regulatory Approval: KOMZIFTI achieved full FDA approval in 2025 for adult patients with relapsed or refractory acute myeloid leukemia harboring an NPM1 mutation, marking a significant breakthrough as the first once-daily oral menin inhibitor approved for this indication.
- Future Outlook: Kura aims to accelerate the U.S. uptake of KOMZIFTI in 2026 and plans to present updated data from the KOMET-007 trial in the first half of the year, which will further enhance product penetration and revenue growth.
Kura Oncology Launches KOMZIFTI, First Once-Daily Oral Menin Inhibitor with $2.1M Initial Revenue
- Product Launch: Kura Oncology's KOMZIFTI™ (ziftomenib), approved by the FDA on November 13, 2025, is the first once-daily oral menin inhibitor designed for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML), marking a significant breakthrough in precision medicine.
- Initial Revenue: The net product revenue of $2.1 million generated in the five-week period from November 21 to December 31, 2025, indicates strong market acceptance and is expected to drive continued growth for the company in 2026.
- Strategic Collaboration: Kura received milestone payments of $195 million under its collaboration agreement with Kyowa Kirin in Q4 2025, further strengthening its financial foundation to support R&D and market expansion plans.
- Future Outlook: Kura anticipates non-cash collaboration revenue recognition of $45 million to $55 million in 2026, combined with $667.3 million in cash and short-term investments as of December 31, 2025, ensuring the ongoing advancement of its ziftomenib program in newly diagnosed AML.
Kura Oncology Launches KOMZIFTI, First Once-Daily Oral Menin Inhibitor with $2.1M Initial Revenue
- Product Launch: Kura Oncology's KOMZIFTI™ (ziftomenib), approved by the FDA on November 13, 2025, is the first once-daily oral menin inhibitor designed for adults with relapsed or refractory NPM1-mutated AML, marking a significant breakthrough in precision medicine.
- Initial Revenue: The net product revenue for KOMZIFTI reached $2.1 million during the five-week period from November 21 to December 31, 2025, indicating strong market demand and rapid adoption, which is expected to drive future revenue growth for the company.
- Strategic Collaboration: Kura secured $195 million in milestone payments under its collaboration agreement with Kyowa Kirin in Q4 2025, further strengthening its financial position and providing funding support for future R&D and market expansion.
- Future Outlook: Kura anticipates non-cash collaboration revenue recognition of $45 million to $55 million in 2026, combined with $667.3 million in cash reserves, which will support the further development of ziftomenib in front-line AML treatment, showcasing the company's long-term potential in oncology.
Kura Oncology Gains Ground After Jim Cramer's Remarks
Cramer’s Mention Boosts Stock: Shares of Kura Oncology (KURA) rose by 12% following a mention on CNBC's "Mad Money" by Jim Cramer, who highlighted the potential of cancer-related stocks as speculative investments.
FDA Approval for Ziftomenib: The stock surge is linked to the recent FDA approval of Kura's drug, Komzifti (ziftomenib), for treating acute myeloid leukemia, which also triggered a $135 million milestone payment from partner Kyowa Kirin.
After-Hours Gains on Friday: Biotech and Genomics Stocks Demonstrate Resilience
Kura Oncology's Gains: Kura Oncology's shares rose 7.42% in after-hours trading, likely due to positive investor reactions to data from its KOMET-007 trial for acute myeloid leukemia.
SOPHiA GENETICS Collaboration: SOPHiA GENETICS saw a 5.21% increase in share price, attributed to ongoing interest in its collaboration with Complete Genomics for precision oncology testing.
Elutia and RenovoRx Performance: Elutia Inc. and RenovoRx, Inc. experienced modest gains, with Elutia up 3.10% and RenovoRx up 2.47%, reflecting steady investor interest in the biotech sector.
Kodiak Sciences and Other Companies: Kodiak Sciences gained 5.42% following a successful public offering, while Day One Biopharmaceuticals and Quantum BioPharma also saw increases, indicating a broader positive trend in biotech stocks.
Kura Oncology Grants Stock Options to New Employees
- Stock Option Grant: On February 2, 2026, Kura Oncology granted 69,750 nonstatutory stock options to four new employees, aimed at attracting and retaining talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Exercise Price Setting: Each stock option has an exercise price of $8.27 per share, matching the closing price on the grant date, which serves to incentivize employees to grow alongside the company.
- Vesting Schedule: The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting monthly, ensuring employee stability during their service with the company.
- Strategic Positioning: Kura Oncology focuses on precision medicine and is committed to developing innovative cancer therapies, particularly with its FDA-approved KOMZIFTI™, demonstrating the company's ongoing commitment to oncology treatment advancements.
Kura Oncology Reports $2.1M KOMZIFTI Revenue in 2025 Financial Results
- Revenue Highlight: Kura Oncology reported $2.1 million in net product revenue from KOMZIFTI (ziftomenib) during the initial five weeks of commercial availability in its preliminary 2025 financial results, indicating strong market acceptance that is expected to drive future revenue growth.
- Milestone Payments: The company received $195 million in milestone payments from its collaboration with Kyowa Kirin in Q4, further strengthening its financial position and providing funding support for ongoing research and development initiatives.
- Regulatory Approval: KOMZIFTI achieved full FDA approval in 2025 for adult patients with relapsed or refractory acute myeloid leukemia harboring an NPM1 mutation, marking a significant breakthrough as the first once-daily oral menin inhibitor approved for this indication.
- Future Outlook: Kura aims to accelerate the U.S. uptake of KOMZIFTI in 2026 and plans to present updated data from the KOMET-007 trial in the first half of the year, which will further enhance product penetration and revenue growth.
Kura Oncology Launches KOMZIFTI, First Once-Daily Oral Menin Inhibitor with $2.1M Initial Revenue
- Product Launch: Kura Oncology's KOMZIFTI™ (ziftomenib), approved by the FDA on November 13, 2025, is the first once-daily oral menin inhibitor designed for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML), marking a significant breakthrough in precision medicine.
- Initial Revenue: The net product revenue of $2.1 million generated in the five-week period from November 21 to December 31, 2025, indicates strong market acceptance and is expected to drive continued growth for the company in 2026.
- Strategic Collaboration: Kura received milestone payments of $195 million under its collaboration agreement with Kyowa Kirin in Q4 2025, further strengthening its financial foundation to support R&D and market expansion plans.
- Future Outlook: Kura anticipates non-cash collaboration revenue recognition of $45 million to $55 million in 2026, combined with $667.3 million in cash and short-term investments as of December 31, 2025, ensuring the ongoing advancement of its ziftomenib program in newly diagnosed AML.
Kura Oncology Launches KOMZIFTI, First Once-Daily Oral Menin Inhibitor with $2.1M Initial Revenue
- Product Launch: Kura Oncology's KOMZIFTI™ (ziftomenib), approved by the FDA on November 13, 2025, is the first once-daily oral menin inhibitor designed for adults with relapsed or refractory NPM1-mutated AML, marking a significant breakthrough in precision medicine.
- Initial Revenue: The net product revenue for KOMZIFTI reached $2.1 million during the five-week period from November 21 to December 31, 2025, indicating strong market demand and rapid adoption, which is expected to drive future revenue growth for the company.
- Strategic Collaboration: Kura secured $195 million in milestone payments under its collaboration agreement with Kyowa Kirin in Q4 2025, further strengthening its financial position and providing funding support for future R&D and market expansion.
- Future Outlook: Kura anticipates non-cash collaboration revenue recognition of $45 million to $55 million in 2026, combined with $667.3 million in cash reserves, which will support the further development of ziftomenib in front-line AML treatment, showcasing the company's long-term potential in oncology.
Kura Oncology Gains Ground After Jim Cramer's Remarks
Cramer’s Mention Boosts Stock: Shares of Kura Oncology (KURA) rose by 12% following a mention on CNBC's "Mad Money" by Jim Cramer, who highlighted the potential of cancer-related stocks as speculative investments.
FDA Approval for Ziftomenib: The stock surge is linked to the recent FDA approval of Kura's drug, Komzifti (ziftomenib), for treating acute myeloid leukemia, which also triggered a $135 million milestone payment from partner Kyowa Kirin.
After-Hours Gains on Friday: Biotech and Genomics Stocks Demonstrate Resilience
Kura Oncology's Gains: Kura Oncology's shares rose 7.42% in after-hours trading, likely due to positive investor reactions to data from its KOMET-007 trial for acute myeloid leukemia.
SOPHiA GENETICS Collaboration: SOPHiA GENETICS saw a 5.21% increase in share price, attributed to ongoing interest in its collaboration with Complete Genomics for precision oncology testing.
Elutia and RenovoRx Performance: Elutia Inc. and RenovoRx, Inc. experienced modest gains, with Elutia up 3.10% and RenovoRx up 2.47%, reflecting steady investor interest in the biotech sector.
Kodiak Sciences and Other Companies: Kodiak Sciences gained 5.42% following a successful public offering, while Day One Biopharmaceuticals and Quantum BioPharma also saw increases, indicating a broader positive trend in biotech stocks.
