Kura Oncology

Brendan, a Ph.D. in organic synthesis from Stanford, worked at Merck and biotech start-ups before co-founding 1200 Pharma. He holds a beneficial long position in KURA shares and is short put options, anticipating a larger position. Investment involves risk; consider objectives, experience, and risk appetite. This is a framework for understanding security price movement, not advice.

Syndax Pharmaceuticals' drug Revuforj, a menin inhibitor, received FDA approval for treating acute leukemia with KMT2A translocation, offering a new treatment option for patients with poor prognoses. The drug, priced at $39,500/month, showed promising results in a Phase 1/2 study, with 21.2% achieving complete remission. Revuforj carries a black box warning for differentiation syndrome risk.

FDA approves Syndax Pharma's Revuforj, an oral menin inhibitor, for relapsed or refractory acute leukaemia with KMT2A gene translocations, marking the first FDA-backed treatment for this type of blood cancer. This follows a disappointing phase 1/2 trial readout for Revuforj in mutant NPM1 acute myeloid leukaemia, causing a drop in Syndax's shares.

Syndax Pharmaceuticals' Phase II trial of revumenib met primary endpoint in relapsed or refractory AML, but stock dropped 25.6%. The AUGMENT-101 trial showed 23% CR/CRh, 4.7 months median duration, and 64% MRD-negative patients. Safety issues included QTc prolongation and differentiation syndrome. Revumenib targets menin-MLL interaction, competing with Kura Oncology's ziftomenib. Revumenib projected to generate $634m by 2030.

JMP Securities' Reni Benjamin maintains Buy rating on Kura Oncology (KURA) with $32.00 price target, citing KOMET-001 study results expected in 2025, breakthrough designation for Zifto in NPM1-m AML, strong cash position, and upcoming data presentations.

Kura Oncology reports Q3 2024 financial results, expecting topline results from ziftomenib trial in R/R NPM1-mutant AML in early 2025. The company plans to present data from 100 patients in the Phase 1a study at ASH, with the Phase 1b expansion study enrolling at 600 mg. Preclinical data supports ziftomenib's potential in GIST, with a proof-of-concept study expected in 1H 2025. Kura also dosed the first patient in the KO-2806 and adagrasib study in KRASG12C-mutated NSCLC. The company reported a net loss of $54.4 million for Q3 2024, with R&D expenses at $41.7 million and G&A expenses at $18.2 million. Kura holds $455.3 million in cash, cash equivalents, and investments, expected to fund operations into 2027.

Kura Oncology to report Q3 2024 financial results on Nov 7, 2024, with a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT. The call can be accessed via phone or webcast on the company's website.

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Stifel downgraded Kura Oncology's stock from Buy to Hold, reducing the price target to $19.00 due to anticipated challenges for ziftomenib in the cancer drug market. Despite progress with ziftomenib, including a breakthrough therapy designation and FDA clearance, Kura reported a net loss of $50.8 million. The company's strong cash position of $491.5 million is expected to fund operations into 2027, and recent advancements include the addition of Dr. Michael J. Vasconcelles to the Board of Directors.