Kura Oncology, Inc. reports news on its precision oncology business, including commercialization of KOMZIFTI™ (ziftomenib), an FDA-approved once-daily oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia. Company updates also cover small-molecule drug candidates designed to target cancer signaling pathways across hematologic malignancies and solid tumors.
Recurring KURA developments include financial results, corporate updates, clinical data presentations, collaboration-related milestones, healthcare conference participation and Nasdaq inducement grants. News on darlifarnib (KO-2806) follows the company’s farnesyl transferase inhibitor program, including studies in combination with cabozantinib for clear cell renal cell carcinoma.
Kura Oncology reported significant results from the Phase 2 RUN-HN trial of tipifarnib for HRAS mutant head and neck squamous cell carcinoma (HNSCC). The objective response rate (ORR) was 55%, with a median progression-free survival (PFS) of 5.6 months, outperforming previous therapies which had a PFS of 3.6 months (p=0.0012). The median overall survival (OS) was recorded at 15.4 months. The safety profile was consistent with earlier data, supporting the advancement of the AIM-HN registration-directed trial. These findings underscore the potential of genomic testing in identifying suitable candidates for tipifarnib treatment.
Kura Oncology reported positive developments regarding its clinical pipeline and financial results for 2020. Preliminary data for KO-539 showed significant single-agent activity in relapsed AML patients, particularly those with NPM1 mutations. The FDA granted Breakthrough Therapy Designation to tipifarnib for treating recurrent HRAS mutant HNSCC. Financially, the company ended 2020 with $633.3 million in cash, ensuring operational funding into 2024. However, Kura also reported an increase in net losses, reaching $89.6 million for the year.
Kura Oncology (Nasdaq: KURA) announced that its drug tipifarnib has received Breakthrough Therapy Designation from the FDA for treating recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC). This designation is based on promising data from the RUN-HN Phase 2 trial, which indicated a 50% objective response rate and improved median overall survival of 15.4 months. HNSCC, with over 885,000 new cases annually, has a poor prognosis and limited treatment options. Tipifarnib also holds Fast Track designation, enhancing its development pathway.
Kura Oncology, a clinical-stage biopharmaceutical company, announced that its CEO, Troy Wilson, will participate in four virtual investor conferences in February and March 2021. Key events include a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on February 25, a panel discussion at the Cowen 41st Annual Health Care Conference on March 3, and a presentation at the Barclays Virtual Global Healthcare Conference on March 10. Kura's drug candidates, including tipifarnib and KO-539, target specific cancer signaling pathways to enhance treatment outcomes.
Kura Oncology, Inc. (Nasdaq: KURA) announced it will report its fourth quarter and full year 2020 financial results on February 24, 2021, before U.S. markets open. Management will host a conference call at 8:00 a.m. ET to discuss these results and provide a corporate update. The company is focused on developing precision medicines for cancer treatment, with two key candidates: tipifarnib for HRAS mutant head and neck cancer, and KO-539 for acute myeloid leukemia, currently in clinical trials. For details, visit their website.
Kura Oncology announced its participation in the H.C. Wainwright BioConnect 2021 Conference, scheduled for January 13, 2021. President and CEO Troy Wilson will join a panel discussion on precision medicine, focusing on the role of biomarkers in drug discovery and commercialization. The panel, led by former FDA Commissioner Dr. Scott Gottlieb, will start at 9:00 a.m. PT. A live audio webcast will be accessible on Kura’s website, followed by an archived replay for 30 days.
Kura Oncology, a clinical-stage biopharmaceutical company focused on precision cancer medicines, will participate in the 39th Annual J.P. Morgan Healthcare Conference. CEO Troy Wilson is scheduled to present on January 12, 2021, at 1:30 p.m. PT / 4:30 p.m. ET. The virtual conference takes place from January 11-14, 2021. A live audio webcast of the presentation will be available on Kura's website and an archived replay will be accessible for 30 days post-event. Kura's leading drug candidates include tipifarnib and KO-539, targeting key cancer pathways.
Kura Oncology, Inc. (Nasdaq: KURA) announced the successful closing of its public offering, selling 9,326,500 shares at $37.00 each, yielding approximately $345.1 million gross proceeds. The underwriters fully exercised their option to purchase an additional 1,216,500 shares. The offering was conducted under a shelf registration effective December 7, 2020. SVB Leerink, Credit Suisse, Barclays, and Stifel served as joint bookrunning managers. Kura aims to utilize these funds to advance its clinical-stage pipeline targeting cancer treatments, particularly focusing on precision medicine.
Kura Oncology, a clinical-stage biopharmaceutical company focused on precision cancer medicine, will participate in the JMP Securities Hematology Summit on December 15, 2020. CEO Troy Wilson will take part in a fireside chat at 11:00 a.m. ET. The summit is hosted virtually from December 15-16, 2020. A live audio webcast of the discussion will be available on Kura's website, with a replay accessible for 30 days. Kura's leading drug candidate is tipifarnib, aimed at treating HRAS mutant head and neck squamous cell carcinoma, alongside KO-539 for acute myeloid leukemia.
Kura Oncology (Nasdaq: KURA) has announced the pricing of an underwritten public offering of 8,110,000 shares of its common stock at $37.00 per share, aiming for gross proceeds of approximately $300 million. The offering includes a 30-day option for underwriters to purchase an additional 1,216,500 shares. The expected closing date is December 11, 2020, pending customary conditions. The securities are offered under a previously filed shelf registration statement.