Federal Judge Allows BioXcel Shareholders Amended Suit Over FDA Trial Compliance

Several significant developments in the biotech and pharmaceutical sectors are anticipated in late 2025, with key FDA decisions poised to influence pediatric treatments and chronic disease management. Arcutis Biotherapeutics has received FDA acceptance for a new drug application for a topical cream aimed at treating atopic dermatitis in young children, based on promising clinical trial data highlighting its efficacy and safety. Ascendis Pharma awaits an FDA decision on navepegritide, an innovative therapy for children with achondroplasia, designed to inhibit a key growth pathway. Amgen and AstraZeneca are expecting FDA approval for Tezspire to treat chronic rhinosinusitis with nasal polyps, expanding its current use in severe asthma and potentially challenging existing therapies due to its biomarker-agnostic profile. Meanwhile, BioXcel Therapeutics faces legal scrutiny over allegations of misrepresenting clinical trial data crucial to its future, and Recursion Pharmaceuticals is viewed as a high-risk investment due to uncertain product timelines despite AI-driven drug discovery optimism. Additionally, the FDA authorized the first eyeglass lenses to slow myopia progression in children and granted accelerated approval to a novel treatment for Barth syndrome, while also considering new warnings for acetaminophen use during pregnancy.