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Enliven Therapeutics reports positive phase 1 CML data and FDA alignment for phase 3 trial (ELVN)

Updated ELVN-001 results showed strong molecular response rates in previously treated CML patients, while the FDA aligned ...

Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the ...

Alterity wins key FDA alignment for pivotal neurological trial

The regulator ticks off on key elements of a phase III trial, including study population, endpoint selection, dosing regimen ...
Mena FN

Nervgen Pharma Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic Tetraplegia

Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in ...
The Manila Times

Alterity Therapeutics Achieves Alignment with U.S. FDA on Pivotal Phase 3 Program for ATH434 in Multiple System Atrophy

Successful End-of-Phase 2 meeting with FDA agreeing on key elements of the proposed Phase 3 design, including study population, dosing regimen, and treatment duration - ...