Shares of Kura Oncology KURA rose 8% after the company announced encouraging preliminary data from the ongoing FIT-001 study evaluating darlifarnib in combination with cabozantinib. The analysis focused on patients with clear cell renal cell carcinoma (ccRCC) who had previously been treated with cabozantinib, a population that typically showed limited response to further treatment.
Year to date, shares of KURA have lost 6.9% against the industry’s 3.5% growth.
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Key Highlights of KURA’s FIT-001 Study
In the FIT-001 study, darlifarnib is being administered at once-daily doses of 3 mg, 5 mg or 8 mg on a seven-day on and off schedule, in combination with cabozantinib, given once daily at 60 mg or 40 mg.
The treatment demonstrated strong anti-tumor activity along with a manageable safety profile across different dose levels, including full-dose cabozantinib. Among 16 evaluable patients, the regimen achieved an objective response rate of 44%, while the disease control rate reached 94% across all dose levels. Tumor shrinkage was observed in 75% of patients, with reductions ranging from 32% to 47% among those who responded.
The treatment showed effectiveness even in heavily pretreated patients, including those whose best prior response to cabozantinib was only stable disease, as well as those who had received additional tyrosine kinase inhibitors. Treatment duration ranged from eight weeks to 56 weeks, with one-third of patientsremaining on therapy at the time of analysis. These findings are particularly significant, as patients who progress on cabozantinib are generally considered unlikely to benefit from further cabozantinib-based treatment.
The study has progressed to the phase Ib dose-expansion stage, aimed at identifying the most effective and biologically active dose for the combination.
Kura Oncology is developing darlifarnib as a broad combination therapy backbone in oncology, with renal cell carcinoma (RCC) as the lead indication. Besides RCC, darlifarnib is being evaluated in combination with adagrasib in a phase I dose-escalation study for treating non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma.
KURA’s Zacks Rank & Stocks to Consider
Kura Oncology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals ANIP, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 12.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 8.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $9.02. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.24. Year to date, shares of ANIP have gained 2.5%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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Catalyst Pharmaceuticals, Inc. (CPRX): Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report
Kura Oncology, Inc. (KURA): Free Stock Analysis Report
Indivior Pharmaceuticals Inc. (INDV): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).