inhaled cromolyn (PHENOGENE-1A) / PhenoNet - LARVOL DELTA

PhenoNet Cleared by FDA to Begin Phase 3 Trial of Inhaled PHENOGENE-1A in Early Alzheimer's Disease (Businesswire) - "The agency issued the 'May Proceed' notification on August 10, 2026, activating the company's Investigational New Drug (IND) application...PhenoNet expects to begin screening the first patients in January 2027....The trial will enroll approximately 648 participants across roughly 90 sites in North America and Europe and will assess the primary endpoint over 72 weeks. With the FDA's 'May Proceed' notification for the active IND, the company intends to pursue a Special Protocol Assessment (SPA) to confirm that the PHENOAD-002 trial design, if successful, can support a future 505(b)(2) NDA submission."

IND • New P3 trial • Alzheimer's Disease

PhenoNet, Inc. Completes Recruitment and Randomization in Phase IIb Clinical Trial Evaluating PHENOGENE-1A for Amyotrophic Lateral Sclerosis (ALS) (Businesswire) - "The ongoing clinical trial...is being conducted at clinical sites across the United States and Europe....If the results of the Phase IIb study are supportive, PhenoNet, Inc. intends to discuss an appropriate registrational development pathway with the U.S. Food and Drug Administration, including the potential use of the 505(b)(2) pathway, a Special Protocol Assessment, and an orphan-drug designation."

Enrollment closed • Amyotrophic Lateral Sclerosis