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Monday, October 30, 2023

Deciphera: Positive Top-line Results in Pivotal Phase 3 Study of Tenosynovial Giant Cell Tumor

 MOTION Study Met Primary Endpoint with Objective Response Rate (ORR) at Week 25 of 40% Compared to 0% for Placebo (p<0.0001) –

– MOTION Study Met All Key Secondary Endpoints with Statistically Significant and Clinically Meaningful Improvements at Week 25 Compared to Placebo, including ORR by Tumor Volume Score (TVS) of 67% vs. 0% (p< 0.0001) –

– Updated Results from Phase 1/2 Study of Vimseltinib Demonstrated Best ORR of 72% (Phase 1) and 64% (Phase 2 Cohort A) with Median Treatment Duration of 25.1 Months (Phase 1) and 21.0 Months (Phase 2 Cohort A) –

– Treatment with Vimseltinib was Well-tolerated with No Evidence of Cholestatic Hepatotoxicity in MOTION and Phase 1/2 Studies –

– Company Expects to Submit New Drug Application (NDA) in Second Quarter 2024 and Marketing Authorisation Application (MAA) in Third Quarter 2024 –

– Conference Call to be Held Today at 8:00 AM ET –

Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIc2885b197da74145bfc30deb5fb11858. A live webcast of the conference call will be available in the “Events and Presentations” page in the “Investors & News” section of the Company’s website at https://investors.deciphera.com/events-presentations. A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

https://www.businesswire.com/news/home/20231030355437/en/

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