Reports Q1: 400mg Dose Selection Increases Confidence Ahead Of YE Pivotal Data

研报英文原文证据摘录

Reports Q1: 400mg Dose Selection Increases Confidence Ahead Of YE Pivotal Data

Biotechnology

Zentalis

TD SECURITIES (USA) LLC EARNINGS UPDATE

May 12, 2026

Price: $4.28 (05/12/2026) Reports Q1: 400mg Dose Selection Increases

Price Target: NA Confidence Ahead Of YE Pivotal Data

BUY (1)

ESG SCORE: 60/100

Tyler Van Buren THE TD COWEN INSIGHT

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The pivotal 400mg QD 5:2 dose for DENALI is locked, which showed stronger efficacy vs

tyler.vanburen@tdsecurities.com

300mg, and improved tolerability vs Part 1. Inclusion of Part 2c (post taxane) strengthens

Ikenna Okafor, Ph.D. the dataset. Topline data across Part 2 are expected by year-end, positioning azeno for an

646 562 1395 Elahere-like accelerated approval and opportunity. Enrollment for the confirmatory ASPENOVA

ikenna.okafor@tdsecurities.com

Phase III trial is underway.

Nicholas Lorusso

646 562 1390 We Are Highly Confident In The Pivotal Topline Data Readout For DENALI Part 2, Which Are

nick.lorusso@tdsecurities.com Expected By The End Of The Year...

Sam Rollenhagen Zentalis recently selected the 400mg QD 5:2 dosing regimen to advance into Part 2b of the

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Phase II DENALI study in CCNE1+ PROC – which is enrolling ~100 patients. We are optimistic

samuel.rollenhagen@tdsecurities.com

about this dose selection, because the company reported that the 400mg dose demonstrated

Key Data a clearly differentiated response rate from 300mg with a comparable safety profile across

Symbol NASDAQ: ZNTL dose groups, including a discontinuation rate due to adverse events approximately half that

Beta: 2.00 observed in DENALI Part 1b and no treatment-related deaths (discussed here). The company

52-Week Range: $6.61-$1.16 is aligned with the FDA on dose and endpoints, supporting a potential accelerated approval