AC Immune Says FDA Grants Fast Track Designation And IND Clearance For Anti-Alpha-Synuclein Immunotherapy ACI-7104 In Early Parkinson's; Phase 2 VacSYn Week-100 Data Expected In H2 2026

FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis

United Therapeutics announced FDA acceptance of a supplemental new drug application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF), with a regulatory decision expected in late April 2027. The TETON phase III studies demonstrated statistically significant improvements in lung function, including a 111.8 mL FVC benefit, reduced clinical worsening, and favorable secondary endpoints. If approved, Tyvaso would be the first FDA-approved inhaled anti-fibrotic treatment for IPF.

AC Immune Says Early Data from Anti-Inflammatory Drug Gives Wider Clinical Momentum for Pipeline

AC Immune reports favorable interim Phase 1 results for ACI-19764, an oral NLRP3 inhibitor showing strong safety and brain penetration.

BTIG Reiterates Buy on AC Immune, Maintains $8 Price Target

BTIG analyst Thomas Shrader reiterates AC Immune (NASDAQ:ACIU) with a Buy and maintains $8 price target.

AC Immune Says NLRP3 Inhibitor ACI-19764 Safe And Well Tolerated In Phase 1 With Confirmed CSF Penetration; Initial Cardiovascular Risk Cohort Results Expected By Year End