December 5, 2024

Alkeus Pharmaceuticals Announces Positive Gildeuretinol Data Will Be Presented During the 12th International FLORetina ICOOR Congress December 5–8 in Florence, Italy

CAMBRIDGE, Mass., December 5, 2024 – Alkeus Pharmaceuticals, Inc. today announced that results from its clinical studies of investigational oral gildeuretinol for the treatment of Stargardt disease (TEASE) will be presented at the 12th International FLORetina ICOOR Congress being held December 5-8 in Florence, Italy.

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November 18, 2024

Alkeus Pharmaceuticals Receives FDA Rare Pediatric Disease and Fast Track Designations for Gildeuretinol as a Treatment for Stargardt Disease

CAMBRIDGE, Mass. — Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received Rare Pediatric Disease and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of Stargardt disease.

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October 23, 2024

Topline Results from Alkeus Pharmaceuticals’ Study of Oral Gildeuretinol Demonstrate Significant Trend in Slowing GA Progression and Visual Function Improvement

CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) treated with investigational oral therapy gildeuretinol (ALK-001) showed a statistically significant reduction in the GA lesion growth rate of 15.3% vs. placebo from 6 to 24 months (p=0.047). Gildeuretinol also demonstrated a statistically significant visual function improvement, showing 4.4 fewer letters lost (p=0.031) in low luminance visual acuity (LLVA) over 24 months. Gildeuretinol showed a clinically meaningful trend in slowing GA growth rate of 13.4% from baseline to 24 months (p=0.075), the study’s primary endpoint. A trend toward functional benefit in best corrected visual acuity (BCVA) was demonstrated with 3.3 fewer letters lost (p=0.099).

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October 17, 2024

Alkeus Pharmaceuticals Announces Data Presentations at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting, October 18-21 in Chicago

CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc. today announced that results from its clinical studies of investigational oral gildeuretinol for the treatment of geographic atrophy secondary to age-related macular degeneration (SAGA) and Stargardt disease (TEASE) will be presented at the 128th annual meeting of the American Academy of Ophthalmology (AAO) being held in Chicago October 18-21, 2024.

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