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Aug 6, 2026Regulatory decision

Zentalis reports Q2 2026 results as DENALI Part 2 nears full enrollment

The company said its accelerated approval strategy for azenosertib remains intact after FDA discussions, with topline DENALI Part 2 data expected in 1H 2027.

Zentalis Pharmaceuticals reported second quarter 2026 financial results and business updates on August 6, 2026, for the period ended June 30, 2026.

The company said the FDA had no objection to continued study of the selected monotherapy dose of azenosertib at 400mg once daily on a 5-days-on, 2-days-off schedule in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC), and acknowledged that the DENALI Part 2 study population, including the 2c cohort, could potentially support an accelerated approval pathway, though this would depend on the strength of the data and the competitive landscape of approved agents at the time of any regulatory decision.1

Enrollment updates: enrollment in DENALI Parts 2a and 2b is complete, while Part 2c is currently enrolling.1 The company said it expects to provide a topline readout in 1H 2027 to allow for data maturation post full enrollment.1

On the confirmatory trial, Zentalis said in May 2026 it dosed the first patient in the Phase 3 ASPENOVA trial, which is intended to meet FDA requirements for full U.S. approval and to support approval in major markets outside the U.S.1 That trial is currently enrolling.1

Financially, the company reported cash, cash equivalents and marketable securities of $174.6 million as of June 30, 2026, down from $245.9 million as of December 31, 2025.1 Zentalis said this balance is expected to fund operations into late 2027.1

Research and development expenses were $35.2 million for the quarter, up from $27.6 million a year earlier, driven partly by a $7.0 million milestone payment to Recurium IP Holdings tied to the start of ASPENOVA.1 Total operating expenses were $44.4 million, versus $36.1 million in the prior-year quarter.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.