KURA

Kura just transitioned from R&D-stage to commercial-stage: the FDA approved KOMZIFTI (ziftomenib) on November 13, 2025 for relapsed/refractory NPM1-mutated AML, and U.S. sales began November 21, 2025. The 10-K language emphasizes a genuine differentiation story — first once-daily oral menin inhibitor, no Black Box for QTc prolongation (unlike the competing approved menin inhibitor), and no dose adjustments with CYP3A4 inhibitors. Combined with Breakthrough/Fast Track/Orphan/Priority Review designations and a 21.4% CR+CRh rate from KOMET-001, this is a credible niche launch with Kyowa Kirin co-commercializing.

The financials, however, are pre-launch and ugly. FY2025 revenue of $67.5M (+25.2% YoY) is overwhelmed by a -$279M net loss (worsening 60% YoY) and -$304M operating loss, with R&D ramping to $251M (+47.7%). Operating cash flow flipped to -$64.1M from positive, total liabilities jumped 62.8% to $564M while equity collapsed -57.9% to $174M (L/E now 3.24x), and cash fell 33.6% to $149M. At 14.1x sales and a market cap of $950M, the stock is already pricing in meaningful KOMZIFTI uptake — yet the FY2025 revenue line is almost entirely pre-approval (approval was Nov 13, sales began Nov 21), so the real launch curve is still unproven.