Twelve applications with September goal dates include six novel agents but only one breakthrough designation.

Emerging Company Profile: With experienced leadership and new financing, Evommune is developing a topical IRAK4 inhibitor for atopic dermatitis and earlier-stage systemic drugs for various conditions.

Lilly agrees to pay about $2.4bn to acquire Dice and its Phase IIb oral IL-17 inhibitor, as well as a discovery platform that has yielded a preclinical oral PD-L1 inhibitor.

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.