Aicuris Receives FDA Priority Review for Pritelivir NDA and Presents New Phase 3 Data at ESCMID 2026 Aicuris today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) filed for pritelivir, and that new extended Phase 3 data will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) 2026 congress in Munich, Germany. The NDA submission is based on initial results from the pivotal Phase 3 trial in which pritelivir met its registrational primary endpoint for the treatment of refractory herpes simplex virus (HSV) infections in immunocompromised patients. The ESCMID presentation includes extended treatment outcomes through 42 days, as well as virology and subgroup analyses.

Aicuris today announced that it has entered into a definitive agreement under which Asahi Kasei will acquire all shares of Aicuris through its U.S. subsidiary Veloxis Pharmaceuticals Inc. for a total of €780 million (~$920 million). The acquisition will enable Asahi Kasei to strategically expand its portfolio of therapies designed to treat severe viral infections, addressing critical infectious complications faced by patients in transplantation and other immunologically-driven conditions.

Aicuris today announced superior efficacy results from a subgroup analysis of its pivotal Phase 3 trial evaluating pritelivir vs. investigator’s choice treatment (ICT) in people living with HIV with refractory herpes simplex virus (HSV) infection. The results were presented as a late-breaking oral presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) on February 25, 2026, in Denver, USA. Similar to other subgroups, pritelivir achieved superior lesion healing of 61% up to 28 days of treatment, compared with 20% for ICT, with an adjusted treatment difference of 37% (p = 0.027, post-hoc analysis).

Aicuris today announced positive results from its pivotal Phase 3 trial evaluating pritelivir in immunocompromised patients with refractory herpes simplex virus (HSV) infections. The results will be presented as an Oral Late Breaker presentation at the 2026 TANDEM Meetings on February 7, 2026, in Salt Lake City, USA. Pritelivir showed a significant superiority in lesion healing of 62.7% compared to 34.0% for ICT and demonstrated fewer treatment-emergent adverse events and drug-related discontinuations compared to standard-of-care therapies. This data will form the basis of a New Drug Application (NDA) submission to the U.S. FDA in Q1of 2026.

Aicuris Announces Pritelivir Phase 3 HSV Data to Be Presented as Late-Breaking Oral Presentation at Tandem Aicuris will share Phase 3 data from for its lead candidate pritelivir in immunocompromised patients with refractory herpes simplex virus infections, at the 2026 Tandem Meetings in Salt Lake City, USA.